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Feasibility, Acceptability, and Clinical Effectiveness of a Technology-Enabled Cardiac Rehabilitation Platform (Physical Activity Toward Health-I): Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Cardiac rehabilitation (CR) is highly effective as secondary prevention for cardiovascular diseases (CVDs). Uptake of CR remains suboptimal (30% of eligible patients), and long-term adherence to a physically active lifestyle is even lower. Innovative strategies are needed to counteract this phenomenon. OBJECTIVE:The Physical Activity Toward Health (PATHway) system was developed to provide a comprehensive, remotely monitored, home-based CR program for CVD patients. The PATHway-I study aimed to investigate its feasibility and clinical efficacy during phase III CR. METHODS:Participants were randomized on a 1:1 basis to the PATHway (PW) intervention group or usual care (UC) control group in a single-blind, multicenter, randomized controlled pilot trial. Outcomes were assessed at completion of phase II CR and 6-month follow-up. The primary outcome was physical activity (PA; Actigraph GT9X link). Secondary outcomes included measures of physical fitness, modifiable cardiovascular risk factors, endothelial function, intima-media thickness of the common carotid artery, and quality of life. System usability and patients' experiences were evaluated only in PW. A mixed-model analysis of variance with Bonferroni adjustment was used to analyze between-group effects over time. Missing values were handled by means of an intention-to-treat analysis. Statistical significance was set at a 2-sided alpha level of .05. Data are reported as mean (SD). RESULTS:A convenience sample of 120 CVD patients (mean 61.4 years, SD 13.5 years; 22 women) was included. The PATHway system was deployed in the homes of 60 participants. System use decreased over time and system usability was average with a score of 65.7 (SD 19.7; range 5-100). Moderate-to-vigorous intensity PA increased in PW (PW: 127 [SD 58] min to 141 [SD 69] min, UC: 146 [SD 66] min to 143 [SD 71] min; Pinteraction=.04; effect size of 0.42), while diastolic blood pressure (PW: 79 [SD 11] mmHg to 79 [SD 10] mmHg, UC: 78 [SD 9] mmHg to 83 [SD 10] mmHg; Pinteraction=.004; effect size of -0.49) and cardiovascular risk score (PW: 15.9% [SD 10.4%] to 15.5% [SD 10.5%], UC: 14.5 [SD 9.7%] to 15.7% [SD 10.9%]; Pinteraction=.004; effect size of -0.36) remained constant, but deteriorated in UC. CONCLUSIONS:This pilot study demonstrated the feasibility and acceptability of a technology-enabled, remotely monitored, home-based CR program. Although clinical effectiveness was demonstrated, several challenges were identified that could influence the adoption of PATHway. TRIAL REGISTRATION:ClinicalTrials.gov NCT02717806; https://clinicaltrials.gov/ct2/show/NCT02717806. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR2-10.1136/bmjopen-2017-016781.

SUBMITTER: Claes J

PROVIDER: S-EPMC7055834 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Feasibility, Acceptability, and Clinical Effectiveness of a Technology-Enabled Cardiac Rehabilitation Platform (Physical Activity Toward Health-I): Randomized Controlled Trial.

Claes Jomme J Cornelissen Véronique V McDermott Clare C Moyna Niall N Pattyn Nele N Cornelis Nils N Gallagher Anne A McCormack Ciara C Newton Helen H Gillain Alexandra A Budts Werner W Goetschalckx Kaatje K Woods Catherine C Moran Kieran K Buys Roselien R

Journal of medical Internet research 20200204 2

<h4>Background</h4>Cardiac rehabilitation (CR) is highly effective as secondary prevention for cardiovascular diseases (CVDs). Uptake of CR remains suboptimal (30% of eligible patients), and long-term adherence to a physically active lifestyle is even lower. Innovative strategies are needed to counteract this phenomenon.<h4>Objective</h4>The Physical Activity Toward Health (PATHway) system was developed to provide a comprehensive, remotely monitored, home-based CR program for CVD patients. The P ...[more]

PMID: 32014842

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Project description:INTRODUCTION:Exercise-based cardiac rehabilitation (CR) independently alters the clinical course of cardiovascular diseases resulting in a significant reduction in all-cause and cardiac mortality. However, only 15%-30% of all eligible patients participate in a phase 2 ambulatory programme. The uptake rate of community-based programmes following phase 2 CR and adherence to long-term exercise is extremely poor. Newer care models, involving telerehabilitation programmes that are delivered remotely, show considerable promise for increasing adherence. In this view, the PATHway (Physical Activity Towards Health) platform was developed and now needs to be evaluated in terms of its feasibility and clinical efficacy. METHODS AND ANALYSIS:In a multicentre randomised controlled pilot trial, 120 participants (m/f, age 40-80?years) completing a phase 2 ambulatory CR programme will be randomised on a 1:1 basis to PATHway or usual care. PATHway involves a comprehensive, internet-enabled, sensor-based home CR platform and provides individualised heart rate monitored exercise programmes (exerclasses and exergames) as the basis on which to provide a personalised lifestyle intervention programme. The control group will receive usual care. Study outcomes will be assessed at baseline, 3?months and 6?months after completion of phase 2 of the CR programme. The primary outcome is the change in active energy expenditure. Secondary outcomes include cardiopulmonary endurance capacity, muscle strength, body composition, cardiovascular risk factors, peripheral endothelial vascular function, patient satisfaction, health-related quality of life (HRQoL), well-being, mediators of behaviour change and safety. HRQoL and healthcare costs will be taken into account in cost-effectiveness evaluation. ETHICS AND DISSEMINATION:The study will be conducted in accordance with the Declaration of Helsinki. This protocol has been approved by the director and clinical director of the PATHway study and by the ethical committee of each participating site. Results will be disseminated via peer-reviewed scientific journals and presentations at congresses and events. TRIAL REGISTRATION NUMBER:NCT02717806. This trial is currently in the pre-results stage.

Project description:BackgroundMany patients do not meet the recommended levels of physical activity after completing a cardiac rehabilitation (CR) program. Wearable activity trackers and mobile phone apps are promising potential self-management tools for maintaining physical activity after CR completion.ObjectiveThis study aims to evaluate the acceptability of a wearable device, mobile app, and push messages to facilitate physical activity following CR completion.MethodsWe used semistructured interviews to assess the acceptability of various mobile technologies after participation in a pilot randomized controlled trial. Intervention patients in the randomized controlled trial wore the Fitbit Charge 2, used the Movn mobile app, and received push messages on cardiovascular disease prevention and physical activity for over 2 months. We asked 26 intervention group participants for feedback about their experience with the technology and conducted semistructured individual interviews with 7 representative participants. We used thematic analysis to create the main themes from individual interviews.ResultsOur sample included participants with a mean age of 66.7 (SD 8.6) years; 23% (6/26) were female. Overall, there were varying levels of satisfaction with different technology components. There were 7 participants who completed the satisfaction questionnaires and participated in the interviews. The Fitbit and Movn mobile app received high satisfaction scores of 4.86 and 4.5, respectively, whereas push messages had a score of 3.14 out of 5. We identified four main themes through the interviews: technology use increased motivation to be physically active, technology use served as a reminder to be physically active, recommendations for technology to improve user experience, and desire for personal feedback.ConclusionsBy applying a wearable activity tracker, mobile phone app, and push messages, our study showed strong potential for the adoption of new technologies by older adults to maintain physical activity after CR completion. Future research should include a larger sample over a longer period using a mixed methods approach to assess the efficacy of technology use for promoting long-term physical activity behavior in older adults.

Project description:ObjectiveThe purpose of this study was to examine the feasibility and acceptability of a wearable device and telehealth counseling physical activity intervention early after lumbar spine surgery.MethodsSixteen patients were randomized to an 8-session physical activity intervention or to usual postoperative care after surgery. The intervention included a wearable device (ie, Fitbit) and telehealth counseling by a licensed physical therapist. The feasibility of study procedures was assessed through recruitment, randomization, retention, and participation rates. Acceptability was assessed through a satisfaction survey and median within-participant change in objective physical activity (steps per day and time spent in moderate-to-vigorous physical activity [MVPA]) and patient-reported outcomes.ResultsOf 64 participants who were eligible, recruitment and randomization rates were 41 and 62%, respectively. Retention for objective physical activity and patient-reported outcomes was 94 and 100%, respectively, at 6-month follow-up. Seven (88%) participants in the intervention group completed all telehealth sessions, and 6 (75%) met step goals over the 8 sessions. All participants in the intervention group found the wearable device and telehealth counseling to be helpful and reported it much or somewhat more important than other postoperative services. Median within-participant change for steps per day improved from baseline (preoperative) to 6 months after surgery for both the intervention (1070) and usual care (679) groups, while MVPA only improved for the intervention group (2.2. minutes per day). Improvements in back and leg pain and disability were noted for both groups. No adverse events were reported in the study.ConclusionCombining wearable technology and telehealth counseling is a feasible approach to promote the physical activity during the early postoperative period after spine surgery. Future randomized controlled trials are needed to investigate the efficacy of leveraging wearables and telehealth during postoperative rehabilitation.ImpactThis study has implications for the clinical dissemination of physical activity strategies in the rehabilitation setting.

Project description:Background: Many children are not engaging in sufficient physical activity and there are substantial between-children physical activity inequalities. In addition to their primary role as educators, teachers are often regarded as being well-placed to make vital contributions to inclusive visions of physical activity promotion. With the dramatic increase in popularity of wearable technologies for physical activity promotion in recent years, there is a need to better understand teachers' perspectives about using such devices, and the data they produce, to support physical activity promotion in schools. Method: Semi-structured interviews were conducted with 26 UK-based primary school teachers, exploring their responses to children's physical activity data and their views about using wearable technologies during the school day. Interview discussions were facilitated by an elicitation technique whereby participants were presented with graphs illustrating children's in-school physical activity obtained from secondary wearable technology data. Interview transcripts were thematically analyzed. Results: Most teachers spoke positively about the use of wearable technologies specifically designed for school use, highlighting potential benefits and considerations. Many teachers were able to understand and critically interpret data showing unequal physical activity patterns both within-and between-schools. Being presented with the data prompted teachers to provide explanations about observable patterns, emotional reactions-particularly about inequalities-and express motivations to change the current situations in schools. Conclusion: These findings suggest that primary school teachers in the UK are open to integrating wearable technology for measuring children's physical activity into their practices and can interpret the data produced by such devices. Visual representations of physical activity elicited strong responses and thus could be used when working with teachers as an effective trigger to inform school practices and policies seeking to address in-school physical inactivity and inequalities.

Project description:BackgroundMobile health (mHealth) technology has the potential to support the Chronic Care Model's vision of closed feedback loops and patient-clinician partnerships.ObjectiveThis study aims to evaluate the feasibility, acceptability, and short-term impact of an electronic health record-linked mHealth platform (Orchestra) supporting patient and clinician collaboration through real-time, bidirectional data sharing.MethodsWe conducted a 6-month prospective, pre-post, proof-of-concept study of Orchestra among patients and parents in the Cincinnati Children's Hospital inflammatory bowel disease (IBD) and cystic fibrosis (CF) clinics. Participants and clinicians used Orchestra during and between visits to complete and view patient-reported outcome (PRO) measures and previsit plans. Surveys completed at baseline and at 3- and 6-month follow-up visits plus data from the platform were used to assess outcomes including PRO completion rates, weekly platform use, disease self-efficacy, and impact on care. Analyses included descriptive statistics; pre-post comparisons; Pearson correlations; and, if applicable, effect sizes.ResultsWe enrolled 92 participants (CF: n=52 and IBD: n=40), and 73% (67/92) completed the study. Average PRO completion was 61%, and average weekly platform use was 80%. Participants reported improvement in self-efficacy from baseline to 6 months (7.90 to 8.44; P=.006). At 6 months, most participants reported that the platform was useful (36/40, 90%) and had a positive impact on their care, including improved visit quality (33/40, 83%), visit collaboration (35/40, 88%), and visit preparation (31/40, 78%). PRO completion was positively associated with multiple indicators of care impact at 3 and 6 months.ConclusionsUse of an mHealth tool to support closed feedback loops through real-time data sharing and patient-clinician collaboration is feasible and shows indications of acceptability and promise as a strategy for improving pediatric chronic illness management.

Project description:BackgroundHeart failure (HF), is a leading cause of cardiovascular morbidity and mortality in Sub-Saharan Africa. Cardiac rehabilitation (CR) is known to improve functional capacity and reduce morbidity associated with HF. Although CR is a low-cost intervention, global access and adherence rates to CR remain poor. In regions such as Western Kenya, CR programs do not exist. We sought to establish the feasibility CR for HF in this region by testing adherence to institution and home-based models of CR.MethodsOne hundred participants with New York Heart Association (NYHA) class II and III HF symptoms were prospectively enrolled from a tertiary health facility in Western Kenya. Participants were non-randomly assigned to participate in one of two CR models based on their preference. Institution based cardiac rehabilitation (IBCR) comprised 36 facility-based exercise sessions over a period of 12 weeks. Home based cardiac rehabilitation (HBCR) comprised weekly pedometer guided exercise targets over a period of 12 weeks. An observational arm (OA) receiving usual care was also enrolled. The primary endpoint of CR feasibility was assessed based on study participants to adherence to at least 25% of exercise sessions. Secondary outcomes of change in NYHA symptom class, and six-minute walk time distance (6MWTD) were also evaluated. Data were summarized and analyzed as means (SD) and frequencies. Paired t-tests, Chi Square, Fisher's, and ANOVA tests were used for comparisons.FindingsMean protocol adherence was greater than 25% in both CR models; 46% ± 18 and 29% ± 11 (P < 0.05) among IBCR and HBCR participants respectively. Improvements by at least one NYHA class were observed among 71%, 41%, and 54%, of IBCR, HBCR and OA participants respectively. 6MWTD increased significantly by a mean of 31 ± 65 m, 40 ± 55 m and 38 ± 71 m in the IBCR, HBCR and OA respectively (P < 0.05).ConclusionsIBCR and HBCR, are feasible rehabilitation models for HF in Western Kenya. Whereas improvement in functional capacity was observed, effectiveness of CR in this population remains unknown. Future randomized studies evaluating effect size, long term efficacy, and safety of cardiac rehabilitation in low resource settings such as Kenya are recommended.

Project description:BackgroundThe adherence to cardiac rehabilitation is low. Social media has been used to improve motivation and cardiac rehabilitation completion, but the authors did not find Facebook interventions for these purposes in the literature.ObjectiveThe purpose of this study was to determine the feasibility of the Cardiac Rehabilitation Facebook Intervention (Chat) for affecting changes in exercise motivation and need satisfaction and adherence to cardiac rehabilitation.MethodsThe Behavioral Regulation in Exercise Questionnaire-3 and Psychological Need Satisfaction for Exercise were used to measure motivation and need satisfaction (competence, autonomy, and relatedness) before and after the Chat intervention. To support need satisfaction, the intervention included educational posts, supportive posts, and interaction with peers. The feasibility measures included recruitment, engagement, and acceptability. Groups were compared using analysis of variance and Kruskal-Wallis tests. Paired t tests were used to assess motivation and need satisfaction change, and Pearson or Spearman correlations were used for continuous variables.ResultsA total of 32 participants were lost to follow-up and 22 were included in the analysis. Higher motivation at intake (relative autonomy index 0.53, 95% CI 0.14-0.78; P=.01) and change in need satisfaction-autonomy (relative autonomy index 0.61, 95% CI 0.09-0.87; P=.02) were associated with more completed sessions. No between-group differences were found. Engagement included "likes" (n=210) and "hits" (n=157). For acceptability, mean scores on a 1 (not at all) to 5 (quite a bit) Likert scale for feeling supported and in touch with providers were 4.6 and 4.4, respectively.ConclusionsAcceptability of the Chat group was high; however, intervention feasibility could not be determined due to the small sample size. Those with greater motivation at intake completed more sessions, indicating its importance in cardiac rehabilitation completion. Despite challenges with recruitment and engagement, important lessons were learned.Trial registrationClinicalTrials.gov NCT02971813; https://clinicaltrials.gov/ct2/show/NCT02971813.International registered report identifier (irrid)RR2-10.2196/resprot.7554.

Dataset Information

Feasibility, Acceptability, and Clinical Effectiveness of a Technology-Enabled Cardiac Rehabilitation Platform (Physical Activity Toward Health-I): Randomized Controlled Trial.

Publications

Feasibility, Acceptability, and Clinical Effectiveness of a Technology-Enabled Cardiac Rehabilitation Platform (Physical Activity Toward Health-I): Randomized Controlled Trial.

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