TY - JOUR AU - Lima, Ana Paula AU - Nascimento, Isabella Oliveira AU - Oliveira, Anne Caroline A AU - Martins, Thiago Henrique S AU - Pereira, Danielle A Gomes AU - Britto, Raquel Rodrigues PY - 2019 DA - 2019/11/7 TI - Home-Based Cardiac Rehabilitation in Brazil’s Public Health Care: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e13901 VL - 8 IS - 11 KW - cardiac rehabilitation KW - coronary disease KW - exercise AB - Background: Coronary artery disease (CAD) is among the main causes of hospitalization and death worldwide, therefore, the implementation of programs to reduce its impact is necessary. Supervised cardiac rehabilitation has been shown to have positive effects on CAD control. However, there are barriers to patient participation in the traditional, face-to-face cardiac rehabilitation programs, mainly in low-resource environments. Objective: This study aimed to verify patient compliance to a home-based cardiac rehabilitation program, which includes unsupervised health education and physical exercises, guided by telephone. Moreover, we compare this new method to the traditional supervised cardiac rehabilitation offered in most hospital centers. Methods: We present here a two-arm, single-blinded, and randomized controlled design protocol, which compares the traditional cardiac rehabilitation (CenterRehab) with the home-based cardiac rehabilitation (Home-Based) in 72 patients affected by CAD. The primary outcome is the compliance to the cardiac rehabilitation sessions. The secondary outcomes (to evaluate effectiveness) include measurable variables such as functional capacity, CAD risk factors (blood pressure, waist circumference, glycemic, cholesterol levels, depressive symptoms, and the level of physical activity), the patient’s quality of life, the disease knowledge, and the morbidity rate. Parameters such as the program cost and the usability will also be evaluated. The programs will last 12 weeks, with a total of 60 rehabilitation and 6 educational sessions. Patients of the CenterRehab program will participate in 24 supervised sessions and 36 home sessions, while the patients of the Home-Based program will participate in 2 supervised sessions and 58 home sessions, guided by telephone. After the 12-week period all participants will be recommended to continue practicing physical exercises at home or at a community center, and they will be invited for re-evaluation after 3 months. The outcomes will be evaluated at baseline, and after 3 and 6 months. Results: Participants are currently being recruited for the trial. Data collection is anticipated to be completed by October 2019. Conclusions: This is the first study in Brazil comparing the traditional cardiac rehabilitation approach with a novel, home-based protocol that uses an accessible and low-cost technology. If positive results are obtained, the study will contribute to establish a new and viable model of cardiac rehabilitation. Trial Registration: ClinicalTrials.gov NCT03605992; https://clinicaltrials.gov/ct2/show/NCT03605992 International Registered Report Identifier (IRRID): DERR1-10.2196/13901 UR - https://www.researchprotocols.org/2019/11/e13901 UR - https://doi.org/10.2196/13901 UR - http://www.ncbi.nlm.nih.gov/pubmed/31697246 DO - 10.2196/13901 ID - info:doi/10.2196/13901 ER - TY - JOUR AU - Kentgen, Markus AU - Varghese, Julian AU - Samol, Alexander AU - Waltenberger, Johannes AU - Dugas, Martin PY - 2019 DA - 2019/08/23 TI - Common Data Elements for Acute Coronary Syndrome: Analysis Based on the Unified Medical Language System JO - JMIR Med Inform SP - e14107 VL - 7 IS - 3 KW - common data elements KW - acute coronary syndrome KW - documentation KW - standardization AB - Background: Standardization in clinical documentation can increase efficiency and can save time and resources. Objective: The objectives of this work are to compare documentation forms for acute coronary syndrome (ACS), check for standardization, and generate a list of the most common data elements using semantic form annotation with the Unified Medical Language System (UMLS). Methods: Forms from registries, studies, risk scores, quality assurance, official guidelines, and routine documentation from four hospitals in Germany were semantically annotated using UMLS. This allowed for automatic comparison of concept frequencies and the generation of a list of the most common concepts. Results: A total of 3710 forms items from 86 sources were semantically annotated using 842 unique UMLS concepts. Half of all medical concept occurrences were covered by 60 unique concepts, which suggests the existence of a core dataset of relevant concepts. Overlap percentages between forms were relatively low, hinting at inconsistent documentation structures and lack of standardization. Conclusions: This analysis shows a lack of standardized and semantically enriched documentation for patients with ACS. Efforts made by official institutions like the European Society for Cardiology have not yet been fully implemented. Utilizing a standardized and annotated core dataset of the most important data concepts could make export and automatic reuse of data easier. The generated list of common data elements is an exemplary implementation suggestion of the concepts to use in a standardized approach. UR - http://medinform.jmir.org/2019/3/e14107/ UR - https://doi.org/10.2196/14107 UR - http://www.ncbi.nlm.nih.gov/pubmed/31444871 DO - 10.2196/14107 ID - info:doi/10.2196/14107 ER - TY - JOUR AU - Sankaran, Supraja AU - Dendale, Paul AU - Coninx, Karin PY - 2019 DA - 2019/04/04 TI - Evaluating the Impact of the HeartHab App on Motivation, Physical Activity, Quality of Life, and Risk Factors of Coronary Artery Disease Patients: Multidisciplinary Crossover Study JO - JMIR Mhealth Uhealth SP - e10874 VL - 7 IS - 4 KW - heart diseases KW - cardiac rehabilitation KW - human factors engineering KW - evaluation studies KW - telerehabilitation KW - mobile app KW - multidisciplinary research AB - Background: Telerehabilitation approaches have been successful in supporting coronary artery disease (CAD) patients to rehabilitate at home after hospital-based rehabilitation. However, on completing a telerehabilitation program, the effects are not sustained beyond the intervention period because of the lack of lifestyle adaptations. Furthermore, decline in patients’ motivation lead to recurrence of disease and increased rehospitalization rates. We developed HeartHab, using persuasive design principles and personalization, to enable sustenance of rehabilitation effects beyond the intervention period. HeartHab promotes patients’ understanding, motivates them to reach personalized rehabilitation goals, and helps to maintain positive lifestyle adaptations during telerehabilitation. Objective: This study aimed to investigate the impact of the HeartHab app on patients’ overall motivation, increasing physical activities, reaching exercise targets, quality of life, and modifiable risk factors in patients with CAD during telerehabilitation. The study also investigated carryover effects to determine the maintenance of effects after the conclusion of the intervention. Methods: A total of 32 CAD patients were randomized on a 1:1 ratio to telerehabilitation or usual care. We conducted a 4-month crossover study with a crossover point at 2 months using a mixed-methods approach for evaluation. We collected qualitative data on users’ motivation, user experience, and quality of life using questionnaires, semistructured interviews and context-based sentiment analysis. Quantitative data on health parameters, exercise capacity, and risk factors were gathered from blood tests and ergo-spirometry tests. Data procured during the app usage phase were compared against baseline values to assess the impact of the app on parameters such as motivation, physical activity, quality of life, and risk factors. Carryover effects were used to gather insights on the maintenance of effects. Results: The qualitative data showed that 75% (21/28) of patients found the HeartHab app motivating and felt encouraged to achieve their rehabilitation targets. 84% (21/25) of patients either reached or exceeded their prescribed physical activity targets. We found positive significant effects on glycated hemoglobin (P=.01; d=1.03; 95% CI 0.24-1.82) with a mean decrease of 1.5 mg/dL and high-density lipoprotein (HDL) cholesterol (P=.04; d=0.78; 95% CI 0.02-1.55) with a mean increase of 0.61 mg/dL after patients used the HeartHab app. We observed significant carryover effects on weight, HDL cholesterol, and maximal oxygen consumption (VO2 max), indicating the maintenance of effects. Conclusions: Persuasive design techniques integrated in HeartHab and tailoring of exercise targets were effective in motivating patients to reach their telerehabilitation targets. This study demonstrated significant effects on glucose and HDL cholesterol and positive carryover effects on weight, HDL cholesterol, and VO2 max. There was also a perceived improvement in quality of life. A longer-term evaluation with more patients could possibly reveal effectiveness on other risk factors and maintenance of the positive health behavior change. Trial Registration: ClinicalTrials.gov NCT03102671; https://clinicaltrials.gov/ct2/show/NCT03102671 (Archived by WebCite at http://www.webcitation.org/76gzI9Pvd) UR - https://mhealth.jmir.org/2019/4/e10874/ UR - https://doi.org/10.2196/10874 UR - http://www.ncbi.nlm.nih.gov/pubmed/30946021 DO - 10.2196/10874 ID - info:doi/10.2196/10874 ER - TY - JOUR AU - Fitze, Daniel P AU - Franchi, Martino AU - Popp, Werner L AU - Ruoss, Severin AU - Catuogno, Silvio AU - Camenisch, Karin AU - Lehmann, Debora AU - Schmied, Christian M AU - Niederseer, David AU - Frey, Walter O AU - Flück, Martin PY - 2019 DA - 2019/03/27 TI - Concentric and Eccentric Pedaling-Type Interval Exercise on a Soft Robot for Stable Coronary Artery Disease Patients: Toward a Personalized Protocol JO - JMIR Res Protoc SP - e10970 VL - 8 IS - 3 KW - cardiovascular rehabilitation KW - concentric and eccentric exercise KW - high-intensity interval training KW - muscle oxygen saturation KW - near-infrared spectroscopy KW - peak oxygen uptake KW - ramp test KW - skeletal muscle power KW - soft robot AB - Background: Cardiovascular diseases are the leading causes of death worldwide, and coronary artery disease (CAD) is one of the most common causes of death in Europe. Leading cardiac societies recommend exercise as an integral part of cardiovascular rehabilitation because it reduces the morbidity and mortality of patients with CAD. Continuous low-intensity exercise using shortening muscle actions (concentric, CON) is a common training modality during cardiovascular rehabilitation. However, a growing clinical interest has been recently developed in high-intensity interval training (HIIT) for stable patients with CAD. Exercise performed with lengthening muscle actions (eccentric, ECC) could be tolerated better by patients with CAD as they can be performed with higher loads and lower metabolic cost than CON exercise. Objective: We developed a clinical protocol on a soft robot to compare cardiovascular and muscle effects of repeated and work-matched CON versus ECC pedaling-type interval exercise between patients with CAD during cardiovascular rehabilitation. This study aims to ascertain whether the developed training protocols affect peak oxygen uptake (VO2peak), peak aerobic power output (Ppeak), and parameters of muscle oxygen saturation (SmO2) during exercise, and anaerobic muscle power. Methods: We will randomize 20-30 subjects to either the CON or ECC group. Both groups will perform a ramp test to exhaustion before and after the training period to measure cardiovascular parameters and SmO2. Moreover, the aerobic skeletal muscle power (Ppeak) is measured weekly during the 8-week training period using a simulated squat jump and a counter movement jump on the soft robot and used to adjust the training load. The pedaling-type interval exercise on the soft robot is performed involving either CON or ECC muscle actions. The soft robotic device being used is a closed kinetic chain, force-controlled interactive training, and testing device for the lower extremities, which consists of two independent pedals and free footplates that are operated by pneumatic artificial muscles. Results: The first patients with CAD, who completed the training, showed protocol-specific improvements, reflecting, in part, the lower aerobic training status of the patient completing the CON protocol. Rehabilitation under the CON protocol, more than under the ECC protocol, improved cardiovascular parameters, that is, VO2peak (+26% vs −6%), and Ppeak (+20% vs 0%), and exaggerated muscle deoxygenation during the ramp test (248% vs 49%). Conversely, markers of metabolic stress and recovery from the exhaustive ramp test improved more after the ECC than the CON protocol, that is, peak blood lactate (−9% vs +20%) and peak SmO2 (+7% vs −7%). Anaerobic muscle power only improved after the CON protocol (+18% vs −15%). Conclusions: This study indicates the potential of the implemented CON and ECC protocols of pedaling-type interval exercise to improve oxygen metabolism of exercised muscle groups while maintaining or even increasing the Ppeak. The ECC training protocol seemingly provided a lower cardiovascular stimulus in patients with CAD while specifically enhancing the reoxygenation and blood lactate clearance in recruited muscle groups during recovery from exercise. Trial Registration: ClinicalTrials.gov NCT02845063; https://clinicaltrials.gov/ct2/show/NCT02845063 UR - https://www.researchprotocols.org/2019/3/e10970/ UR - https://doi.org/10.2196/10970 UR - http://www.ncbi.nlm.nih.gov/pubmed/30916659 DO - 10.2196/10970 ID - info:doi/10.2196/10970 ER - TY - JOUR AU - Duan, Yan Ping AU - Liang, Wei AU - Guo, Lan AU - Wienert, Julian AU - Si, Gang Yan AU - Lippke, Sonia PY - 2018 DA - 2018/11/19 TI - Evaluation of a Web-Based Intervention for Multiple Health Behavior Changes in Patients With Coronary Heart Disease in Home-Based Rehabilitation: Pilot Randomized Controlled Trial JO - J Med Internet Res SP - e12052 VL - 20 IS - 11 KW - eHealth KW - physical activity KW - diet KW - cardiac rehabilitation KW - health resources AB - Background: Web-based and theory-based interventions for multiple health behaviors appears to be a promising approach with respect to the adoption and maintenance of a healthy lifestyle in cardiac patients who have been discharged from the hospital. Until now, no randomized controlled trials have tested this assumption among Chinese rehabilitation patients with coronary heart disease using a Web-based intervention. Objective: The study aim was to evaluate the effect of an 8-week Web-based intervention in terms of physical activity (PA), fruit and vegetable consumption (FVC), lifestyle changes, social-cognitive outcomes, and health outcomes compared with a waiting control group in Chinese cardiac patients. The intervention content was theory-based on the health action process approach. Self-reported data were evaluated, including PA, FVC, healthy lifestyle (the synthesis of PA and FVC), internal resources (combination of intention, self-efficacy, and planning), and an external resource (social support) of PA and FVC behaviors, as well as perceived health outcomes (body mass index, quality of life, and depression). Methods: In a randomized controlled trial, 136 outpatients with coronary heart disease from the cardiac rehabilitation center of a hospital in China were recruited. After randomization and exclusion of unsuitable participants, 114 patients were assigned to 1 of the 2 groups: (1) the intervention group: first 4 weeks on PA and subsequent 4 weeks on FVC and (2) the waiting control group. A total of 2 Web-based assessments were conducted, including 1 at the beginning of the intervention (T1, N=114), and 1 at the end of the 8-week intervention (T2, N=83). The enrollment and follow-up took place from December 2015 to May 2016. Results: The Web-based intervention outperformed the control condition for PA, FVC, internal resources of PA and FVC, and an external resource of FVC, with an eta-squared effect size ranging from 0.06 to 0.43. Furthermore, the intervention effect was seen in the improvement of quality of life (F1,79=16.36, P<.001, η2=.17). When predicting a healthy lifestyle at follow-up, baseline lifestyle (odds ratio, OR 145.60, 95% CI 11.24-1886; P<.001) and the intervention (OR 21.32, 95% CI 2.40-189.20; P=.006) were found to be significant predictors. Internal resources for FVC mediated the effect of the intervention on the adoption of a healthy lifestyle (R2adj=.29; P=.001), indicating that if the intervention increased the internal resource of behavior, the adoption of a healthy lifestyle was more likely. Conclusions: Patients’ psychological resources such as motivation, self-efficacy, planning, and social support as well as lifestyle can be improved by a Web-based intervention that focuses on both PA and FVC. Such an intervention enriches extended rehabilitation approaches for cardiac patients to be active and remain healthy in daily life after hospital discharge. Trial Registration: ClinicalTrials.gov NCT01909349; https://clinicaltrials.gov/ct2/show/NCT01909349 (Archived by WebCite at http://www.webcitation.org/6pHV1A0G1) UR - http://www.jmir.org/2018/11/e12052/ UR - https://doi.org/10.2196/12052 UR - http://www.ncbi.nlm.nih.gov/pubmed/30455167 DO - 10.2196/12052 ID - info:doi/10.2196/12052 ER - TY - JOUR AU - Bashi, Nazli AU - Hassanzadeh, Hamed AU - Varnfield, Marlien AU - Wee, Yong AU - Walters, Darren AU - Karunanithi, Mohanraj PY - 2018 DA - 2018/10/31 TI - Multidisciplinary Smartphone-Based Interventions to Empower Patients With Acute Coronary Syndromes: Qualitative Study on Health Care Providers’ Perspectives JO - JMIR Cardio SP - e10183 VL - 2 IS - 2 KW - acute coronary syndrome KW - focus group KW - health care professionals KW - mobile phone KW - multidisciplinary KW - thematic analysis AB - Background: Postdischarge interventions are limited in patients with acute coronary syndrome (ACS) due to few scheduled visits to outpatient clinics and travel from remote areas. Smartphones have become a viable lifestyle technology to deliver educational and health interventions following discharge from hospital. Objective: The purpose of this study was to identify the requirements for the delivery of a mobile health intervention for the postdischarge management of patients with ACS via a multidisciplinary focus group. Methods: We conducted a focus group among health care professionals (n=10) from a large metropolitan hospital in May 2017. These participants from a multidisciplinary team contributed to a 1-hour discussion by responding to 8 questions relating to the applicability of smartphone-based educational and health interventions. Descriptive statistics of the focus group data were analyzed using SPSS. The qualitative data were analyzed according to relevant themes extracted from the focus group transcription, using a qualitative description software program (NVivo 11) and an ontology-based concept mapping approach. Results: The mean age of the participants was 47 (SD 8) years: 3 cardiologists; 2 nurse practitioners; 2 clinical nurses; 2 research scientists; and 1 physiotherapist. Of these participants, 70% (7/10) had experience using electronic health intervention during their professional practice. A total of 7 major themes and their subthemes emerged from the qualitative analysis. Health care providers indicated that comprehensive education on diet, particularly providing daily meal plans, is critical for patients with ACS. In terms of ACS symptoms, a strong recommendation was to focus on educating patients instead of daily monitoring of chest pain and shortness of breathing due to subjectivity and insufficient information for clinicians. Participants pointed that monitoring health measures such as blood pressure and body weight may result in increased awareness of patient physical health, yet may not be sufficient to support patients with ACS via the smartphone-based intervention. Therefore, monitoring pain and emotional status along with other health measures was recommended. Real-time support via FaceTime or video conferencing was indicated as motivational and supportive for patient engagement and self-monitoring. The general demographics of patients with ACS being older, having a low educational level, and a lack of computer skills were identified as potential barriers for engagement with the smartphone-based intervention. Conclusions: A smartphone-based program that incorporates the identified educational materials and health interventions would motivate patients with ACS to engage in the multidisciplinary intervention and improve their health outcomes following discharge from hospital. UR - http://cardio.jmir.org/2018/2/e10183/ UR - https://doi.org/10.2196/10183 UR - http://www.ncbi.nlm.nih.gov/pubmed/31758781 DO - 10.2196/10183 ID - info:doi/10.2196/10183 ER - TY - JOUR AU - Avila, Andrea AU - Claes, Jomme AU - Goetschalckx, Kaatje AU - Buys, Roselien AU - Azzawi, May AU - Vanhees, Luc AU - Cornelissen, Véronique PY - 2018 DA - 2018/06/22 TI - Home-Based Rehabilitation With Telemonitoring Guidance for Patients With Coronary Artery Disease (Short-Term Results of the TRiCH Study): Randomized Controlled Trial JO - J Med Internet Res SP - e225 VL - 20 IS - 6 KW - cardiac rehabilitation KW - telemonitoring KW - exercise KW - coronary artery disease AB - Background: Cardiac rehabilitation (CR) is an essential part of contemporary coronary heart disease management. However, patients exiting a center-based CR program have difficulty retaining its benefits. Objective: We aimed to evaluate the added benefit of a home-based CR program with telemonitoring guidance on physical fitness in patients with coronary artery disease (CAD) completing a phase II ambulatory CR program and to compare the effectiveness of this program in a prolonged center-based CR intervention by means of a randomized controlled trial. Methods: Between February 2014 and August 2016, 90 CAD patients (unblinded, mean age 61.2 years, SD 7.6; 80/90, 89.0% males; mean height 1.73 m, SD 0.7; mean weight 82.9 kg, SD 13; mean body mass index 27.5 kg/m2, SD 3.4) who successfully completed a 3-month ambulatory CR program were randomly allocated to one of three groups: home-based (30), center-based (30), or control group (30) on a 1:1:1 basis. Home-based patients received a home-based exercise intervention with telemonitoring guidance consisting of weekly emails or phone calls; center-based patients continued the standard in-hospital CR, and control group patients received the usual care including the advice to remain physically active. All the patients underwent cardiopulmonary exercise testing for assessment of their peak oxygen uptake (VO2 P) at baseline and after a 12-week intervention period. Secondary outcomes included physical activity behavior, anthropometric characteristics, traditional cardiovascular risk factors, and quality of life. Results: Following 12 weeks of intervention, the increase in VO2 P was larger in the center-based (P=.03) and home-based (P=.04) groups than in the control group. In addition, oxygen uptake at the first (P-interaction=.03) and second (P-interaction=.03) ventilatory thresholds increased significantly more in the home-based group than in the center-based group. No significant changes were observed in the secondary outcomes. Conclusions: Adding a home-based exercise program with telemonitoring guidance following completion of a phase II ambulatory CR program results in further improvement of physical fitness and is equally as effective as prolonging a center-based CR in patients with CAD. Trial Registration: ClinicalTrials.gov NCT02047942; https://clinicaltrials.gov/ct2/show/NCT02047942 (Archived by WebCite at http://www.webcitation.org/70CBkSURj) UR - http://www.jmir.org/2018/6/e225/ UR - https://doi.org/10.2196/jmir.9943 UR - http://www.ncbi.nlm.nih.gov/pubmed/29934286 DO - 10.2196/jmir.9943 ID - info:doi/10.2196/jmir.9943 ER - TY - JOUR AU - Östbring, Malin Johansson AU - Eriksson, Tommy AU - Petersson, Göran AU - Hellström, Lina PY - 2018 DA - 2018/02/20 TI - Motivational Interviewing and Medication Review in Coronary Heart Disease (MIMeRiC): Protocol for a Randomized Controlled Trial Investigating Effects on Clinical Outcomes, Adherence, and Quality of Life JO - JMIR Res Protoc SP - e57 VL - 7 IS - 2 KW - medication adherence KW - medication therapy management KW - pharmacist KW - coronary artery disease KW - randomized controlled trial AB - Background: Preventive treatment goals for blood pressure and cholesterol levels continue to be unmet for many coronary patients. The effect of drug treatment depends on both its appropriateness and the patients’ adherence to the treatment regimen. There is a need for adherence interventions that have a measurable effect on clinical outcomes. Objective: This study aims to evaluate the effects on treatment goals of an intervention designed to improve patient adherence and treatment quality in secondary prevention of coronary heart disease. A protocol for the prespecified process evaluation of the trial is published separately. Methods: The Motivational Interviewing and Medication Review in Coronary heart disease (MIMeRiC) trial is a prospective, randomized, outcomes-blinded trial designed to compare individualized follow-up by a clinical pharmacist using motivational interviewing (MI) and medication review with standard follow-up. Patients were randomized to 2 groups after stratification according to their beliefs about medicines. After standard follow-up at the cardiology clinic, patients in the intervention group are seen individually by a clinical pharmacist 2 to 5 times as required over 7 months, at the clinic. The pharmacist reviews each patient’s medication and uses MI to manage any problems with prescribing and adherence. The primary study outcome is the proportion of patients who have reached the treatment goal for low-density lipoprotein cholesterol by 12 months after discharge. Secondary outcomes are the effects on patient adherence, systolic blood pressure, disease-specific quality of life, and health care use. Results: The protocol for this study was approved by the Regional Ethics Committee, Linköping, in 2013. Enrollment started in October 2013 and ended in December 2016 when 417 patients had been included. Follow-up data collection will conclude in March 2018. Publication of the primary and secondary outcome results from the MIMeRiC trial is anticipated in 2019. Conclusions: The MIMeRiC trial will assess the effectiveness of an intervention involving medication reviews and individualized support. The results will inform the continued development of support for this large group of patients who use preventive medicines for lifelong treatment. The design of this adherence intervention is based on a theoretical framework and is the first trial of an intervention that uses beliefs about medicines to individualize the intervention protocol. Trial Registration: ClinicalTrials.gov NCT02102503; https://clinicaltrials.gov/ct2/show/NCT02102503 (Archived by WebCite at http://www.webcitation.org/6x7iUDohy) UR - http://www.researchprotocols.org/2018/2/e57/ UR - https://doi.org/10.2196/resprot.8659 UR - http://www.ncbi.nlm.nih.gov/pubmed/29463490 DO - 10.2196/resprot.8659 ID - info:doi/10.2196/resprot.8659 ER - TY - JOUR AU - Östbring, Malin Johansson AU - Eriksson, Tommy AU - Petersson, Göran AU - Hellström, Lina PY - 2018 DA - 2018/01/30 TI - Motivational Interviewing and Medication Review in Coronary Heart Disease (MIMeRiC): Intervention Development and Protocol for the Process Evaluation JO - JMIR Res Protoc SP - e21 VL - 7 IS - 1 KW - medication adherence KW - medication therapy management KW - pharmacist KW - coronary artery disease, quality of health care AB - Background: Trials of complex interventions are often criticized for being difficult to interpret because the effects of apparently similar interventions vary across studies dependent on context, targeted groups, and the delivery of the intervention. The Motivational Interviewing and Medication Review in Coronary heart disease (MIMeRiC) trial is a randomized controlled trial (RCT) of an intervention aimed at improving pharmacological secondary prevention. Guidelines for the development and evaluation of complex interventions have recently highlighted the need for better reporting of the development of interventions, including descriptions of how the intervention is assumed to work, how this theory informed the process evaluation, and how the process evaluation relates to the outcome evaluation. Objective: This paper aims to describe how the intervention was designed and developed. The aim of the process evaluation is to better understand how and why the intervention in the MIMeRiC trial was effective or not effective. Methods: The research questions for evaluating the process are based on the conceptual model of change processes assumed in the intervention and will be analyzed by qualitative and quantitative methods. Quantitative data are used to evaluate the medication review in terms of drug-related problems, to describe how patients’ beliefs about medicines are affected by the intervention, and to evaluate the quality of motivational interviewing. Qualitative data will be used to analyze whether patients experienced the intervention as intended, how cardiologists experienced the collaboration and intervention, and how the intervention affected patients’ overall experience of care after coronary heart disease. Results: The development and piloting of the intervention are described in relation to the theoretical framework. Data for the process evaluation will be collected until March 2018. Some process evaluation questions will be analyzed before, and others will be analyzed after the outcomes of the MIMeRiC RCT are known. Conclusions: This paper describes the framework for the design of the intervention tested in the MIMeRiC trial, development of the intervention from the pilot stage to the complete trial intervention, and the framework and methods for the process evaluation. Providing the protocol of the process evaluation allows prespecification of the processes that will be evaluated, because we hypothesize that they will determine the outcomes of the MIMeRiC trial. This protocol also constitutes a contribution to the new field of process evaluations as made explicit in health services research and clinical trials of complex interventions. UR - http://www.researchprotocols.org/2018/1/e21/ UR - https://doi.org/10.2196/resprot.8660 UR - http://www.ncbi.nlm.nih.gov/pubmed/29382630 DO - 10.2196/resprot.8660 ID - info:doi/10.2196/resprot.8660 ER - TY - JOUR AU - Chen, Shu AU - Gong, Enying AU - Kazi, Dhruv S AU - Gates, Ann B AU - Bai, Rong AU - Fu, Hua AU - Peng, Weixia AU - De La Cruz, Ginny AU - Chen, Lei AU - Liu, Xianxia AU - Su, Qingjie AU - Girerd, Nicolas AU - Karaye, Kamilu M AU - Alhabib, Khalid F AU - Yan, Lijing L AU - Schwalm, JD PY - 2018 DA - 2018/01/25 TI - Using Mobile Health Intervention to Improve Secondary Prevention of Coronary Heart Diseases in China: Mixed-Methods Feasibility Study JO - JMIR Mhealth Uhealth SP - e9 VL - 6 IS - 1 KW - coronary heart disease KW - secondary prevention KW - medication adherence KW - mobile applications KW - text messaging AB - Background: Coronary heart disease (CHD) is the leading cause of cardiovascular mortality worldwide, yet implementation of evidence-based strategies for secondary prevention remains suboptimal. Objective: This study aimed to evaluate the feasibility, specifically the usability and acceptability, and estimate the preliminary effectiveness of a mobile health (mHealth) intervention targeting both physicians and patients to improve adherence to evidence-based medications and lifestyle modifications. Methods: We conducted a 12-week pre-post interventional pilot study at two sites in Shanghai and Hainan, China. Physicians used the app designed in this study to prescribe evidence-based medicines and record patient information. Eligible and consenting patients received automatic text messages or voice calls 4 to 5 times per week for 12 weeks on medication adherence and healthy behaviors. Interviews were conducted among 10 physicians and 24 patients at the two sites for their thoughts on medication adherence and feedback on the usability and acceptability. Questions on usability and acceptability were also asked in a patient follow-up survey. With regard to estimating effectiveness, the primary outcome was medication adherence (as estimated by the Morisky Green Levine Scale) at 12 weeks. Secondary outcomes included physical activity, smoking status, fruits and vegetables consumption, and facility visit frequency. Results: Interview findings and patient survey showed the good usability and acceptability of the intervention. Among 190 patients who completed the intervention, there was a significant increase in medication adherence (odds ratio [OR] 1.80, 95% CI 1.14-2.85). The study also showed decrease of smokers’ percentage (−5%, P=.05), increase of daily vegetables consumption frequency (+0.3/day, P=.01), and community health care center visit frequency (+3 in 3 months, P=.04). The following site-specific differences were noted: medication adherence appeared to increase in Hainan (OR 14.68, 95% CI 5.20-41.45) but not in Shanghai (OR 0.61, 95% CI 0.33-1.12). Conclusions: Our study demonstrated that the intervention was feasible in both a tertiary care center and an urban community health center in China. Preliminary results from pre-post comparison suggest the possibility that provider and patient-linked mHealth interventions may improve medication adherence and lifestyle modifications among CHD patients, especially in resource-scarce settings. Randomized controlled trials are needed to verify the findings. UR - http://mhealth.jmir.org/2018/1/e9/ UR - https://doi.org/10.2196/mhealth.7849 UR - http://www.ncbi.nlm.nih.gov/pubmed/29371178 DO - 10.2196/mhealth.7849 ID - info:doi/10.2196/mhealth.7849 ER - TY - JOUR AU - Partridge, Stephanie R AU - Gallagher, Patrick AU - Freeman, Becky AU - Gallagher, Robyn PY - 2018 DA - 2018/01/17 TI - Facebook Groups for the Management of Chronic Diseases JO - J Med Internet Res SP - e21 VL - 20 IS - 1 KW - social media, prevention, intervention, Facebook UR - http://www.jmir.org/2018/1/e21/ UR - https://doi.org/10.2196/jmir.7558 UR - http://www.ncbi.nlm.nih.gov/pubmed/29343460 DO - 10.2196/jmir.7558 ID - info:doi/10.2196/jmir.7558 ER - TY - JOUR AU - Marcolino, Milena Soriano AU - Oliveira, João Antonio Queiroz AU - D'Agostino, Marcelo AU - Ribeiro, Antonio Luiz AU - Alkmim, Maria Beatriz Moreira AU - Novillo-Ortiz, David PY - 2018 DA - 2018/01/17 TI - The Impact of mHealth Interventions: Systematic Review of Systematic Reviews JO - JMIR Mhealth Uhealth SP - e23 VL - 6 IS - 1 KW - telemedicine KW - medical informatics KW - mobile phones AB - Background: Mobile phone usage has been rapidly increasing worldwide. mHealth could efficiently deliver high-quality health care, but the evidence supporting its current effectiveness is still mixed. Objective: We performed a systematic review of systematic reviews to assess the impact or effectiveness of mobile health (mHealth) interventions in different health conditions and in the processes of health care service delivery. Methods: We used a common search strategy of five major scientific databases, restricting the search by publication date, language, and parameters in methodology and content. Methodological quality was evaluated using the Measurement Tool to Assess Systematic Reviews (AMSTAR) checklist. Results: The searches resulted in a total of 10,689 articles. Of these, 23 systematic reviews (371 studies; more than 79,665 patients) were included. Seventeen reviews included studies performed in low- and middle-income countries. The studies used diverse mHealth interventions, most frequently text messaging (short message service, SMS) applied to different purposes (reminder, alert, education, motivation, prevention). Ten reviews were rated as low quality (AMSTAR score 0-4), seven were rated as moderate quality (AMSTAR score 5-8), and six were categorized as high quality (AMSTAR score 9-11). A beneficial impact of mHealth was observed in chronic disease management, showing improvement in symptoms and peak flow variability in asthma patients, reducing hospitalizations and improving forced expiratory volume in 1 second; improving chronic pulmonary diseases symptoms; improving heart failure symptoms, reducing deaths and hospitalization; improving glycemic control in diabetes patients; improving blood pressure in hypertensive patients; and reducing weight in overweight and obese patients. Studies also showed a positive impact of SMS reminders in improving attendance rates, with a similar impact to phone call reminders at reduced cost, and improved adherence to tuberculosis and human immunodeficiency virus therapy in some scenarios, with evidence of decrease of viral load. Conclusions: Although mHealth is growing in popularity, the evidence for efficacy is still limited. In general, the methodological quality of the studies included in the systematic reviews is low. For some fields, its impact is not evident, the results are mixed, or no long-term studies exist. Exceptions include the moderate quality evidence of improvement in asthma patients, attendance rates, and increased smoking abstinence rates. Most studies were performed in high-income countries, implying that mHealth is still at an early stage of development in low-income countries. UR - http://mhealth.jmir.org/2018/1/e23/ UR - https://doi.org/10.2196/mhealth.8873 UR - http://www.ncbi.nlm.nih.gov/pubmed/29343463 DO - 10.2196/mhealth.8873 ID - info:doi/10.2196/mhealth.8873 ER - TY - JOUR AU - Birkeland, Kade AU - Khandwalla, Raj M AU - Kedan, Ilan AU - Shufelt, Chrisandra L AU - Mehta, Puja K AU - Minissian, Margo B AU - Wei, Janet AU - Handberg, Eileen M AU - Thomson, Louise EJ AU - Berman, Daniel S AU - Petersen, John W AU - Anderson, R David AU - Cook-Wiens, Galen AU - Pepine, Carl J AU - Bairey Merz, C Noel PY - 2017 DA - 2017/12/20 TI - Daily Activity Measured With Wearable Technology as a Novel Measurement of Treatment Effect in Patients With Coronary Microvascular Dysfunction: Substudy of a Randomized Controlled Crossover Trial JO - JMIR Res Protoc SP - e255 VL - 6 IS - 12 KW - angina KW - coronary microvascular dysfunction KW - physical activity AB - Background: Digital wearable devices provide a “real-world” assessment of physical activity and quantify intervention-related changes in clinical trials. However, the value of digital wearable device-recorded physical activity as a clinical trial outcome is unknown. Objective: Because late sodium channel inhibition (ranolazine) improves stress laboratory exercise duration among angina patients, we proposed that this benefit could be quantified and translated during daily life by measuring digital wearable device-determined step count in a clinical trial. Methods: We conducted a substudy in a randomized, double-blinded, placebo-controlled, crossover trial of participants with angina and coronary microvascular dysfunction (CMD) with no obstructive coronary artery disease to evaluate the value of digital wearable device monitoring. Ranolazine or placebo were administered (500-1000 mg twice a day) for 2 weeks with a subsequent 2-week washout followed by crossover to ranolazine or placebo (500-1000 mg twice a day) for an additional 2 weeks. The outcome of interest was within-subject difference in Fitbit Flex daily step count during week 2 of ranolazine versus placebo during each treatment period. Secondary outcomes included within-subject differences in angina, quality of life, myocardial perfusion reserve, and diastolic function. Results: A total of 43 participants were enrolled in the substudy and 30 successfully completed the substudy for analysis. Overall, late sodium channel inhibition reduced within-subject daily step count versus placebo (mean 5757 [SD 3076] vs mean 6593 [SD 339], P=.01) but did not improve angina (Seattle Angina Questionnaire-7 [SAQ-7]) (P=.83). Among the subgroup with improved angina (SAQ-7), a direct correlation with increased step count (r=.42, P=.02) was observed. Conclusions: We report one of the first studies to use digital wearable device-determined step count as an outcome variable in a placebo-controlled crossover trial of late sodium channel inhibition in participants with CMD. Our substudy demonstrates that late sodium channel inhibition was associated with a decreased step count overall, although the subgroup with angina improvement had a step count increase. Our findings suggest digital wearable device technology may provide new insights in clinical trial research. Trial Registration: Clinicaltrials.gov NCT01342029; https://clinicaltrials.gov/ct2/show/NCT01342029 (Archived by WebCite at http://www.webcitation.org/6uyd6B2PO) UR - http://www.researchprotocols.org/2017/12/e255/ UR - https://doi.org/10.2196/resprot.8057 UR - http://www.ncbi.nlm.nih.gov/pubmed/29263019 DO - 10.2196/resprot.8057 ID - info:doi/10.2196/resprot.8057 ER - TY - JOUR AU - Alonzo, Angelo A PY - 2017 DA - 2017/10/13 TI - Studying Acute Coronary Syndrome Through the World Wide Web: Experiences and Lessons JO - JMIR Res Protoc SP - e182 VL - 6 IS - 10 KW - acute coronary syndrome KW - care-seeking KW - Internet study KW - Internet recruitment UR - http://www.researchprotocols.org/2017/10/e182/ UR - https://doi.org/10.2196/resprot.6788 UR - http://www.ncbi.nlm.nih.gov/pubmed/29030328 DO - 10.2196/resprot.6788 ID - info:doi/10.2196/resprot.6788 ER - TY - JOUR AU - Brokmann, Jörg C AU - Conrad, Clemens AU - Rossaint, Rolf AU - Bergrath, Sebastian AU - Beckers, Stefan K AU - Tamm, Miriam AU - Czaplik, Michael AU - Hirsch, Frederik PY - 2016 DA - 2016/12/01 TI - Treatment of Acute Coronary Syndrome by Telemedically Supported Paramedics Compared With Physician-Based Treatment: A Prospective, Interventional, Multicenter Trial JO - J Med Internet Res SP - e314 VL - 18 IS - 12 KW - acute coronary syndrome KW - prehospital emergency care KW - telemedicine KW - telehealth KW - myocardial infarction AB - Background: Prehospital treatment of acute coronary syndrome (ACS) in German emergency medical services (EMSs) is reserved for EMS physicians due to legal issues. Objective: The objective of this prospective, interventional, multicenter trial was to evaluate the quality of telemedically-delegated therapy and the possible complications in patients with ACS. Methods: After approval by the ethics committee and trial registration, a one-year study phase was started in August 2012 with 5 ambulances, telemedically equipped and staffed with paramedics, in 4 German EMS districts. The paramedics could contact an EMS-physician–staffed telemedicine center. After initiation of an audio connection, real-time data transmission was automatically established. If required, 12-lead electrocardiogram (ECG) and still pictures could be sent. Video was streamed from inside each ambulance. All drugs, including opioids, were delegated to the paramedics based on standardized, predefined algorithms. To compare telemedically-delegated medication and treatment in ACS cases with regular EMS missions, a matched pair analysis with historical controls was performed. Results: Teleconsultation was performed on 150 patients having a cardiovascular emergency. In 39 cases, teleconsultation was started due to suspected ACS. No case had a medical complication. Correct handling of 12-lead ECG was performed equally between the groups (study group, n=38 vs control group, n=39, P>.99). There were no differences in correct handling of intravenous administration of acetylsalicylic acid, heparin, or morphine between both the groups (study group vs control group): acetylsalicylic acid, n=31 vs n=33, P=.73; unfractionated heparin, n=34 vs n=33, P>.99; morphine, n=29 vs n=27, P=.50. The correct handling of oxygen administration was significantly higher in the study group (n=29 vs n=18, P=.007). Conclusions: Telemedical delegation of guideline conform medication and therapy by paramedics in patients with ACS and was found to be feasible and safe. The quality of guideline-adherent therapy was not significantly different in both the groups except for the correct administration of oxygen, which was significantly higher in the study group. Trial Registration: Clinicaltrials.gov NCT01644006; http://clinicaltrials.gov/ct2/show/NCT01644006 (Archived by WebCite at http://www.webcitation.org/6mPam3eDy). UR - http://www.jmir.org/2016/12/e314/ UR - https://doi.org/10.2196/jmir.6358 UR - http://www.ncbi.nlm.nih.gov/pubmed/27908843 DO - 10.2196/jmir.6358 ID - info:doi/10.2196/jmir.6358 ER - TY - JOUR AU - Farias-Itao, Daniela Souza AU - Pasqualucci, Carlos Augusto AU - Nishizawa, Aline AU - Silva, Luiz Fernando Ferraz AU - Campos, Fernanda Marinho AU - Silva, Karen Cristina Souza da AU - Leite, Renata Elaine Paraizo AU - Grinberg, Lea Tenenholz AU - Ferretti-Rebustini, Renata Eloah Lucena AU - Jacob Filho, Wilson AU - Suemoto, Claudia Kimie PY - 2016 DA - 2016/11/18 TI - Perivascular Adipose Tissue Inflammation and Coronary Artery Disease: An Autopsy Study Protocol JO - JMIR Res Protoc SP - e211 VL - 5 IS - 4 KW - coronary artery disease KW - atherosclerosis KW - inflammation KW - adipose tissue KW - macrophages KW - B lymphocytes KW - T lymphocytes AB - Background: Perivascular adipose tissue (PAT) inflammation may have a role in coronary artery disease (CAD) pathophysiology. However, most evidence has come from samples obtained during surgical procedures that may imply in some limitations. Moreover, the role of B lymphocytes and inflammation in PAT that is adjacent to unstable atheroma plaques has not been investigated in humans using morphometric measurements. Objective: The objective of this study is to investigate the inflammation in PAT, subcutaneous, and perirenal adipose tissues (SAT and PrAT) among chronic CAD, acute CAD, and control groups in an autopsy study. Methods: Heart, SAT, and PrAT samples are collected from autopsied subjects in a general autopsy service, with the written informed consent of the next-of-kin (NOK). Sociodemographic and clinical data are obtained from a semistructure interview with the NOK. Coronary arteries are dissected and PAT are removed. Sections with the greatest arterial obstruction or unstable plaques, and the local with absence of atherosclerosis in all coronary arteries are sampled. PAT are represented adjacent to these fragments. Adipose tissues are fixed in 4% buffered paraformaldehyde solution and analyzed immunohistochemically for macrophages (CD68), macrophage polarization (CD11c for proinflammatory and CD206 for anti-inflammatory), B lymphocytes (CD20), and T lymphocytes (CD3). Slides will be scanned, and inflammatory cells will be quantified in 20 random fields. Participants will be categorized in CAD groups, after morphometric measurement of arterial obstruction and plaque composition analysis in accordance with American Heart Association classification. Three study groups will be investigated: acute CAD (at least one unstable plaque); chronic CAD (≥50% arterial obstruction); and controls (<50% arterial obstruction). Inflammatory cells in PAT, SAT, and PrAT will be counted and compared between groups using multivariate linear regression, adjusted for age, body mass index, hypertension, diabetes, alcohol use, and smoking. Results: We present the methods of our study that was developed from 2 pilots. Currently, data collection and tissue processing are ongoing. Data collection, histology and immunochemistry procedures, and quantification of all inflammatory cells are expected to be concluded within 1 year. Conclusions: This study will contribute for the understanding of the mechanisms of CAD pathophysiology because it will help to clarify the role of inflammation both in chronic and acute CAD. UR - http://www.researchprotocols.org/2016/4/e211/ UR - https://doi.org/10.2196/resprot.6340 UR - http://www.ncbi.nlm.nih.gov/pubmed/27864166 DO - 10.2196/resprot.6340 ID - info:doi/10.2196/resprot.6340 ER - TY - JOUR AU - Pfaeffli Dale, Leila AU - Whittaker, Robyn AU - Jiang, Yannan AU - Stewart, Ralph AU - Rolleston, Anna AU - Maddison, Ralph PY - 2015 DA - 2015/10/21 TI - Text Message and Internet Support for Coronary Heart Disease Self-Management: Results From the Text4Heart Randomized Controlled Trial JO - J Med Internet Res SP - e237 VL - 17 IS - 10 KW - text messaging KW - mHealth KW - cellular phone KW - cardiovascular diseases KW - intervention KW - lifestyle change KW - behavior AB - Background: Mobile technology has the potential to deliver behavior change interventions (mHealth) to reduce coronary heart disease (CHD) at modest cost. Previous studies have focused on single behaviors; however, cardiac rehabilitation (CR), a component of CHD self-management, needs to address multiple risk factors. Objective: The aim was to investigate the effectiveness of a mHealth-delivered comprehensive CR program (Text4Heart) to improve adherence to recommended lifestyle behaviors (smoking cessation, physical activity, healthy diet, and nonharmful alcohol use) in addition to usual care (traditional CR). Methods: A 2-arm, parallel, randomized controlled trial was conducted in New Zealand adults diagnosed with CHD. Participants were recruited in-hospital and were encouraged to attend center-based CR (usual care control). In addition, the intervention group received a personalized 24-week mHealth program, framed in social cognitive theory, sent by fully automated daily short message service (SMS) text messages and a supporting website. The primary outcome was adherence to healthy lifestyle behaviors measured using a self-reported composite health behavior score (≥3) at 3 and 6 months. Secondary outcomes included clinical outcomes, medication adherence score, self-efficacy, illness perceptions, and anxiety and/or depression at 6 months. Baseline and 6-month follow-up assessments (unblinded) were conducted in person. Results: Eligible patients (N=123) recruited from 2 large metropolitan hospitals were randomized to the intervention (n=61) or the control (n=62) group. Participants were predominantly male (100/123, 81.3%), New Zealand European (73/123, 59.3%), with a mean age of 59.5 (SD 11.1) years. A significant treatment effect in favor of the intervention was observed for the primary outcome at 3 months (AOR 2.55, 95% CI 1.12-5.84; P=.03), but not at 6 months (AOR 1.93, 95% CI 0.83-4.53; P=.13). The intervention group reported significantly greater medication adherence score (mean difference: 0.58, 95% CI 0.19-0.97; P=.004). The majority of intervention participants reported reading all their text messages (52/61, 85%). The number of visits to the website per person ranged from zero to 100 (median 3) over the 6-month intervention period. Conclusions: A mHealth CR intervention plus usual care showed a positive effect on adherence to multiple lifestyle behavior changes at 3 months in New Zealand adults with CHD compared to usual care alone. The effect was not sustained to the end of the 6-month intervention. A larger study is needed to determine the size of the effect in the longer term and whether the change in behavior reduces adverse cardiovascular events. Trial Registration: ACTRN 12613000901707; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364758&isReview=true (Archived by WebCite at http://www.webcitation.org/6c4qhcHKt) UR - http://www.jmir.org/2015/10/e237/ UR - https://doi.org/10.2196/jmir.4944 UR - http://www.ncbi.nlm.nih.gov/pubmed/26490012 DO - 10.2196/jmir.4944 ID - info:doi/10.2196/jmir.4944 ER - TY - JOUR AU - Schweier, Rebecca AU - Romppel, Matthias AU - Richter, Cynthia AU - Hoberg, Eike AU - Hahmann, Harry AU - Scherwinski, Inge AU - Kosmützky, Gregor AU - Grande, Gesine PY - 2014 DA - 2014/07/23 TI - A Web-Based Peer-Modeling Intervention Aimed at Lifestyle Changes in Patients With Coronary Heart Disease and Chronic Back Pain: Sequential Controlled Trial JO - J Med Internet Res SP - e177 VL - 16 IS - 7 KW - coronary artery disease KW - lifestyle KW - health behavior KW - back pain KW - personal narratives as topic KW - Internet KW - diet KW - exercise KW - Web-based intervention AB - Background: Traditional secondary prevention programs often fail to produce sustainable behavioral changes in everyday life. Peer-modeling interventions and integration of peer experiences in health education are a promising way to improve long-term effects in behavior modification. However, effects of peer support modeling on behavioral change have not been evaluated yet. Therefore, we implemented and evaluated a website featuring patient narratives about successful lifestyle changes. Objective: Our aim is to examine the effects of using Web-based patient narratives about successful lifestyle change on improvements in physical activity and eating behavior for patients with coronary heart disease and chronic back pain 3 months after participation in a rehabilitation program. Methods: The lebensstil-aendern (“lifestyle-change”) website is a nonrestricted, no-cost, German language website that provides more than 1000 video, audio, and text clips from interviews with people with coronary heart disease and chronic back pain. To test efficacy, we conducted a sequential controlled trial and recruited patients with coronary heart disease and chronic back pain from 7 inpatient rehabilitation centers in Germany. The intervention group attended a presentation on the website; the control group did not. Physical activity and eating behavior were assessed by questionnaire during the rehabilitation program and 12 weeks later. Analyses were conducted based on an intention-to-treat and an as-treated protocol. Results: A total of 699 patients were enrolled and 571 cases were included in the analyses (control: n=313, intervention: n=258; female: 51.1%, 292/571; age: mean 53.2, SD 8.6 years; chronic back pain: 62.5%, 357/571). Website usage in the intervention group was 46.1% (119/258). In total, 141 trial participants used the website. Independent t tests based on the intention-to-treat protocol only demonstrated nonsignificant trends in behavioral change related to physical activity and eating behavior. Multivariate regression analyses confirmed belonging to the intervention group was an independent predictor of self-reported improvements in physical activity regularity (β=.09, P=.03) and using less fat for cooking (β=.09, P=.04). In independent t tests based on the as-treated protocol, website use was associated with higher self-reported improvements in integrating physical activity into daily routine (d=0.22, P=.02), in physical activity regularity (d=0.23, P=.02), and in using less fat for cooking (d=0.21, P=.03). Multivariate regression analyses revealed that using the website at least 3 times was the only factor associated with improved lifestyle behaviors. Conclusions: Usage of the lebensstil-aendern website corresponds to more positive lifestyle changes. However, as-treated analyses do not allow for differentiating between causal effects and selection bias. Despite these limitations, the trial indicates that more than occasional website usage is necessary to reach dose-response efficacy. Therefore, future studies should concentrate on strategies to improve adherence to Web-based interventions and to encourage more frequent usage of these programs. UR - http://www.jmir.org/2014/7/e177/ UR - https://doi.org/10.2196/jmir.3434 UR - http://www.ncbi.nlm.nih.gov/pubmed/25057119 DO - 10.2196/jmir.3434 ID - info:doi/10.2196/jmir.3434 ER -