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E-Rehabilitation - an Internet and mobile phone based tailored intervention to enhance self-management of cardiovascular disease: study protocol for a randomized controlled trial.

ABSTRACT: Cardiac rehabilitation is very important for the recovery and the secondary prevention of cardiovascular disease, and one of its main strategies is to increase the level of physical activity. Internet and mobile phone based interventions have been successfully used to help people to achieve this. One of the components that are related to the efficacy of these interventions is tailoring of content to the individual. This trial is studying the effect of a longitudinally tailored Internet and mobile phone based intervention that is based on models of health behaviour, on the level of physical activity and the adherence to the intervention, as an extension of a face-to-face cardiac rehabilitation stay.A parallel group, cluster randomized controlled trial. The study population is adult participants of a cardiac rehabilitation programme in Norway with home Internet access and mobile phone, who in monthly clusters are randomized to the control or the intervention condition. Participants have access to a website with information regarding cardiac rehabilitation, an online discussion forum and an online activity calendar. Those randomized to the intervention condition, receive in addition tailored content based on models of health behaviour, through the website and mobile text messages. The objective is to assess the effect of the intervention on maintenance of self-management behaviours after the rehabilitation stay. Main outcome is the level of physical activity one month, three months and one year after the end of the cardiac rehabilitation programme. The randomization of clusters is based on a true random number online service, and participants, investigators and outcome assessor are blinded to the condition of the clusters.The study suggests a theory-based intervention that combines models of health behaviour in an innovative way, in order to tailor the delivered content. The users have been actively involved in its design, and because of the use of Open-Source software, the intervention can easily and at low-cost be reproduced and expanded by others. Challenges are the recruitment in the elderly population and the possible underrepresentation of women in the study sample. Funding by Northern Norway Regional Health Authority.Trial registry http://www.clinicaltrials.gov: NCT01223170.

SUBMITTER: Antypas K

PROVIDER: S-EPMC3483248 | biostudies-literature | 2012 Jul

REPOSITORIES: biostudies-literature

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E-Rehabilitation - an Internet and mobile phone based tailored intervention to enhance self-management of cardiovascular disease: study protocol for a randomized controlled trial.

Antypas Konstantinos K Wangberg Silje C SC

BMC cardiovascular disorders 20120709

<h4>Unlabelled</h4><h4>Background</h4>Cardiac rehabilitation is very important for the recovery and the secondary prevention of cardiovascular disease, and one of its main strategies is to increase the level of physical activity. Internet and mobile phone based interventions have been successfully used to help people to achieve this. One of the components that are related to the efficacy of these interventions is tailoring of content to the individual. This trial is studying the effect of a long ...[more]

PMID: 22776554

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Project description:An increase in physical activity for secondary prevention of cardiovascular disease and cardiac rehabilitation has multiple therapeutic benefits, including decreased mortality. Internet- and mobile-based interventions for physical activity have shown promising results in helping users increase or maintain their level of physical activity in general and specifically in secondary prevention of cardiovascular diseases and cardiac rehabilitation. One component related to the efficacy of these interventions is tailoring of the content to the individual.Our trial assessed the effect of a longitudinally tailored Internet- and mobile-based intervention for physical activity as an extension of a face-to-face cardiac rehabilitation stay. We hypothesized that users of the tailored intervention would maintain their physical activity level better than users of the nontailored version.The study population included adult participants of a cardiac rehabilitation program in Norway with home Internet access and a mobile phone. The participants were randomized in monthly clusters to a tailored or nontailored (control) intervention group. All participants had access to a website with information regarding cardiac rehabilitation, an online discussion forum, and an online activity calendar. Those using the tailored intervention received tailored content based on models of health behavior via the website and mobile fully automated text messages. The main outcome was self-reported level of physical activity, which was obtained using an online international physical activity questionnaire at baseline, at discharge, and at 1 month and 3 months after discharge from the cardiac rehabilitation program.Included in the study were 69 participants. One month after discharge, the tailored intervention group (n=10) had a higher median level of overall physical activity (median 2737.5, IQR 4200.2) than the control group (n=14, median 1650.0, IQR 2443.5), but the difference was not significant (Kolmogorov-Smirnov Z=0.823, P=.38, r=.17). At 3 months after discharge, the tailored intervention group (n=7) had a significantly higher median level of overall physical activity (median 5613.0, IQR 2828.0) than the control group (n=12, median 1356.0, IQR 2937.0; Kolmogorov-Smirnov Z=1.397, P=.02, r=.33). The median adherence was 45.0 (95% CI 0.0-169.8) days for the tailored group and 111.0 (95% CI 45.1-176.9) days for the control group; however, the difference was not significant (P=.39). There were no statistically significant differences between the 2 groups in stage of change, self-efficacy, social support, perceived tailoring, anxiety, or depression.Because of the small sample size and the high attrition rate at the follow-up visits, we cannot make conclusions regarding the efficacy of our approach, but the results indicate that the tailored version of the intervention may have contributed to the long-term higher physical activity maintained after cardiac rehabilitation by participants receiving the tailored intervention compared with those receiving the nontailored intervention.ClinicalTrials.gov: NCT01223170; http://clinicaltrials.gov/show/NCT01223170 (Archived by WebCite at http://www.webcitation.org/6Nch4ldcL).

Project description:BackgroundWith an explosive growth in mobile health, an estimated 500 million patients are potentially using mHealth apps for supporting health and self-care of chronic diseases. Therefore, this review focused on mHealth apps for use among patients with heart failure.ObjectiveThe aim of this integrative review was to identify and assess the functionalities of mHealth apps that provided usability and efficacy data and apps that are commercially available without supporting data, all of which are to support heart failure self-care management and thus impact heart failure outcomes.MethodsA search of published, peer-reviewed literature was conducted for studies of technology-based interventions that used mHealth apps specific for heart failure. The initial database search yielded 8597 citations. After filters for English language and heart failure, the final 487 abstracts was reviewed. After removing duplicates, a total of 18 articles that tested usability and efficacy of mobile apps for heart failure self-management were included for review. Google Play and Apple App Store were searched with specified criteria to identify mHealth apps for heart failure. A total of 26 commercially available apps specific for heart failure were identified and rated using the validated Mobile Application Rating Scale.ResultsThe review included studies with low-quality design and sample sizes ranging from 7 to 165 with a total sample size of 847 participants from all 18 studies. Nine studies assessed usability of the newly developed mobile health system. Six of the studies included are randomized controlled trials, and 4 studies are pilot randomized controlled trials with sample sizes of fewer than 40. There were inconsistencies in the self-care components tested, increasing bias. Thus, risk of bias was assessed using the Cochrane Collaboration's tool for risk of selection, performance, detection, attrition, and reporting biases. Most studies included in this review are underpowered and had high risk of bias across all categories. Three studies failed to provide enough information to allow for a complete assessment of bias, and thus had unknown or unclear risk of bias. This review on the commercially available apps demonstrated many incomplete apps, many apps with bugs, and several apps with low quality.ConclusionsThe heterogeneity of study design, sample size, intervention components, and outcomes measured precluded the performance of a systematic review or meta-analysis, thus introducing bias of this review. Although the heart failure-related outcomes reported in this review vary, they demonstrated trends toward making an impact and offer a potentially cost-effective solution with 24/7 access to symptom monitoring as a point of care solution, promoting patient engagement in their own home care.

Project description:BACKGROUND:Patients with type 2 diabetes mellitus (T2DM) struggle with the management of their condition due to difficulty relating lifestyle behaviors with glycemic control. While self-monitoring of blood glucose (SMBG) has proven to be effective for those treated with insulin, it has been shown to be less beneficial for those only treated with oral medications or lifestyle modification. We hypothesized that the effective self-management of non-insulin treated T2DM requires a behavioral intervention that empowers patients with the ability to self-monitor, understand the impact of lifestyle behaviors on glycemic control, and adjust their self-care based on contextualized SMBG data. OBJECTIVE:The primary objective of this randomized controlled trial (RCT) is to determine the impact of bant2, an evidence-based, patient-centered, behavioral mobile app intervention, on the self-management of T2DM. Our second postulation is that automated feedback delivered through the mobile app will be as effective, less resource intensive, and more scalable than interventions involving additional health care provider feedback. METHODS:This study is a 12-month, prospective, multicenter RCT in which 150 participants will be randomly assigned to one of two groups: the control group will receive current standard of care, and the intervention group will receive the mobile phone app system in addition to standard of care. The primary outcome measure is change in glycated hemoglobin A1c from baseline to 12 months. RESULTS:The first patient was enrolled on July 28, 2015, and we anticipate completing this study by September, 2018. CONCLUSIONS:This RCT is one of the first to evaluate an evidence-based mobile app that focuses on facilitating lifestyle behavior change driven by contextualized and structured SMBG. The results of this trial will provide insights regarding the usage of mobile tools and consumer-grade devices for diabetes self-care, the economic model of using incentives to motivate behavior change, and the consumption of test strips when following a rigorously structured approach for SMBG. TRIAL REGISTRATION:ClinicalTrials.gov NCT02370719; https://clinicaltrials.gov/ct2/show/NCT02370719 (Archived at http://www.webcitation.org/6jpyjfVRs).

Project description:There is increased research interest in the use of mobile phone apps to support diabetes management. However, there are divergent views on what constitute the minimum standards for inclusion in the development of mobile phone apps. Mobile phone apps require an evidence-based approach to development which will consequently impact on their effectiveness. Therefore, comprehensive information on developmental considerations could help designers and researchers to develop innovative and effective patient-centered self-management mobile phone apps for diabetes patients.This systematic review examined the developmental considerations adopted in trials that engaged mobile phone applications for diabetes self-management.A comprehensive search strategy was implemented across 5 electronic databases; Medline, Scopus, Social Science Citation Index, the Cochrane Central Register of Controlled Trials and Cumulative Index of Nursing and Allied Health Literature (CINALHL) and supplemented by reference list from identified studies. Study quality was evaluated using the Joanna Briggs Critical appraisal checklist for trials. Information on developmental factors (health behavioral theory, functionality, pilot testing, user and clinical expert involvements, data privacy and app security) were assessed across experimental studies using a template developed for the review.A total of 11 studies (10 randomized controlled trials and 1 quasi-experimental trial) that fitted the inclusion criteria were identified. All the included studies had the functionality of self-monitoring of blood glucose. However, only some of them included functions for data analytics (7/11, 63.6%), education (6/11, 54.5%) and reminder (6/11, 54.5%). There were 5/11(45.5%) studies with significantly improved glycosylated hemoglobin in the intervention groups where educational functionality was present in the apps used in the 5 trials. Only 1 (1/11, 9.1%) study considered health behavioral theory and user involvement, while 2 (2/11, 18.1%) other studies reported the involvement of clinical experts in the development of their apps. There were 4 (4/11, 36.4%) studies which referred to data security and privacy considerations during their app development while 7 (7/12, 63.6%) studies provided information on pilot testing of apps before use in the full trial. Overall, none of the studies provided information on all developmental factors assessed in the review.There is a lack of elaborate and detailed information in the literature regarding the factors considered in the development of apps used as interventions for diabetes self-management. Documentation and inclusion of such vital information will foster a transparent and shared decision-making process that will ultimately lead to the development of practical and user-friendly self-management apps that can enhance the quality of life for diabetes patients.

Project description:This paper reports on how the clinical consultation in primary care is performed under the new premises of patients' daily self-reporting and self-generation of data. The aim was to explore and describe the structure, topic initiation and patients' contributions in follow-up consultations after eight weeks of self-reporting through a mobile phone-based hypertension self-management support system.A qualitative, explorative study design was used, examining 20 audio- (n?=?10) and video-recorded (n?=?10) follow-up consultations in primary care hypertension management, through interaction analysis. Clinical trials registry: ClinicalTrials.gov NCT01510301.Four primary health care centers in Sweden.Patients with hypertension (n?=?20) and their health care professional (n?=?7).The consultations comprised three phases: opening, examination and closing. The most common topic was blood pressure (BP) put in relation to self-reported variables, for example, physical activity and stress. Topic initiation was distributed symmetrically between parties and BP talk was lifestyle-centered. The patients' contributed to the interpretation of BP values by connecting them to specific occasions, providing insights to the link between BP measurements and everyday life activities.Patients' contribution through interpretations of BP values to specific situations in their own lives brought on consultations where the patient as a person in context became salient. Further, the patients' and health care professionals' equal contribution during the consultations showed actively involved patients. The mobile phone-based self-management support system can thus be used to support patient involvement in consultations with a person-centered approach in primary care hypertension management Key points ? The clinical consultation is important to provide opportunities for patients to gain understanding of factors affecting high blood pressure, and for health care professionals to motivate and promote changes in life-style. This study shows that self-reporting as base for follow-up consultations in primary care hypertension management can support patients and professionals to equal participation in clinical consultations. Self-reporting combined with increased patient-health care professional interaction during follow-up consultations can support patients in understanding the blood pressure value in relation to their daily life. These findings implicate that the interactive mobile phone self-management support system has potential to support current transformations of patients as recipients of primary care, to being actively involved in their own health.

Dataset Information

E-Rehabilitation - an Internet and mobile phone based tailored intervention to enhance self-management of cardiovascular disease: study protocol for a randomized controlled trial.

Publications

E-Rehabilitation - an Internet and mobile phone based tailored intervention to enhance self-management of cardiovascular disease: study protocol for a randomized controlled trial.

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