Dataset Information

Mobile Health Intervention Promoting Physical Activity in Adults Post Cardiac Rehabilitation: Pilot Randomized Controlled Trial.

ABSTRACT:

Background

Cardiac rehabilitation (CR) is an exercise-based program prescribed after cardiac events associated with improved physical, mental, and social functioning; however, many patients return to a sedentary lifestyle leading to deteriorating functional capacity after discharge from CR. Physical activity (PA) is critical to avoid recurrence of cardiac events and mortality and maintain functional capacity. Leveraging mobile health (mHealth) strategies to increase adherence to PA is a promising approach. Based on the social cognitive theory, we sought to determine whether mHealth strategies (Movn mobile app for self-monitoring, supportive push-through messages, and wearable activity tracker) would improve PA and functional capacity over 2 months.

Objective

The objectives of this pilot randomized controlled trial were to examine preliminary effects of an mHealth intervention on group differences in PA and functional capacity and group differences in depression and self-efficacy to maintain exercise after CR.

Methods

During the final week of outpatient CR, patients were randomized 1:1 to the intervention group or usual care. The intervention group downloaded the Movn mobile app, received supportive push-through messages on motivation and educational messages related to cardiovascular disease (CVD) management 3 times per week, and wore a Charge 2 (Fitbit Inc) activity tracker to track step counts. Participants in the usual care group wore a pedometer and recorded their daily steps in a diary. Data from the 6-minute walk test (6MWT) and self-reported questionnaires were collected at baseline and 2 months.

Results

We recruited 60 patients from 2 CR sites at a community hospital in Northern California. The mean age was 68.0 (SD 9.3) years, and 23% (14/60) were female; retention rate was 85% (51/60). Our results from 51 patients who completed follow-up showed the intervention group had a statistically significant higher mean daily step count compared with the control (8860 vs 6633; P=.02). There was no difference between groups for the 6MWT, depression, or self-efficacy to maintain exercise.

Conclusions

This intervention addresses a major public health initiative to examine the potential for mobile health strategies to promote PA in patients with CVD. Our technology-based pilot mHealth intervention provides promising results on a pragmatic and contemporary approach to promote PA by increasing daily step counts after completing CR.

Trial registration

ClinicalTrials.gov NCT03446313; https://clinicaltrials.gov/ct2/show/NCT03446313.

SUBMITTER: Park LG

PROVIDER: S-EPMC8087971 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:Home-based cardiac rehabilitations (CRs) with digital technologies have been researched and implemented to replace, augment, and complement traditional center-based CR in recent years with considerable success. One problem that technology-enhanced home-based CR can potentially address is the gap between cardiac interventions and formal CR programs. In the Netherlands and some other countries (eg, Australia), patients after cardiac interventions stay at home for 3-4 weeks without much support from their physicians, and often engage in very little physical activity (PA). A home-based exercise program enabled by digital technologies may help patients to better prepare for the later center-based CR programs, potentially increasing the uptake rate of those programs. OBJECTIVE:In a randomized controlled trial (RCT), we will evaluate the effectiveness of a home-based walking exercise program enhanced by self-tracking and mobile-based coaching (treatment condition), comparing it with a version of the same program without these technologies (control condition). The added value of the digital technologies is justified if patients in the treatment group walk more steps on average (primary outcome) and show better physical fitness in a bicycle ergometer test and higher self-efficacy toward PA (secondary outcomes). METHODS:Based on a power analysis, we will recruit 100 cardiac patients and assign them evenly to the 2 parallel groups. Eligible patients are those who are scheduled in the postanesthesia care unit, know the Dutch language, have basic literacy of using smartphones, and are without medical conditions that may increase risks associated with PA. In a face-to-face meeting with a nurse practitioner, all patients are prescribed a 3-week exercise program at home (2 walking exercises per day with increasing duration), based on national and international guidelines and tailored to their physical conditions after cardiac intervention. Their physical activities (daily steps) will be measured by the Axivity AX3 accelerometer worn at hip position. Patients in the treatment group will also be supported by a Neo Health One self-tracking device and a mobile platform called Heart Angel, through which they are monitored and coached by their nurses. After the study, all patients will perform a bicycle ergometer test and return the devices within 1 week. In addition, 5 questionnaires will be sent to the patients by emails to assess their self-efficacy toward PA and other psychological states for exploratory analyses (at discharge, at the end of each monitoring week, and 1 week after the study). To minimize bias, the randomization procedure will be performed after introducing the exercise program, so the nurse practitioners are blind to the experimental conditions until that point. RESULTS:The study protocol has been approved by the Medical Research Ethics Committees United on February 26, 2018 (NL 62142.100.17/R17.51). By the end of 2018, we completed a small pilot study with 8 patients and the results based on interviews and app usage data suggest that a larger clinical trial with the targeted population is feasible. We expect to complete the RCT by the end of 2021, and statistical analyses will follow. CONCLUSIONS:Results of the RCT will help us to test the hypothesized benefits of self-tracking and mobile-based coaching for cardiac patients in home-based exercise programs during the discharge-rehabilitation gap. If the results are positive, cost-effectiveness analysis will be performed based on the insights of the study to inform the translation of the technology-enhanced program to clinical practice. We also note limitations of the trial in the discussion. TRIAL REGISTRATION:Registered at Netherlands Trial Register NL8040; https://www.trialregister.nl/trial/8040. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/16737.

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:BackgroundBaseline physical activity in patients when they initiate cardiac rehabilitation is poorly understood. We used mobile health technology to understand baseline physical activity of patients initiating cardiac rehabilitation within a clinical trial to potentially inform personalized care.MethodsThe VALENTINE (Virtual Application-Supported Environment to Increase Exercise During Cardiac Rehabilitation Study) is a prospective, randomized-controlled, remotely administered trial designed to evaluate a mobile health intervention to supplement cardiac rehabilitation for low- and moderate-risk patients. All participants receive a smartwatch and usual care. Baseline physical activity was assessed remotely after enrollment and included (1) 6-minute walk distance, (2) daily step count, and (3) daily exercise minutes, both over 7 days and for compliant days, defined by >8 hours of watch wear time. Multivariable linear regression identified patient-level features associated with these 3 measures of baseline physical activity.ResultsFrom October 2020 to March 2022, 220 participants enrolled in the study. Participants are mostly White (184 [83.6%]); 67 (30.5%) are female and 84 (38.2%) are >65 years old. Most participants enrolled in cardiac rehabilitation after percutaneous coronary intervention (105 [47.7%]) or coronary artery bypass surgery (39 [17.7 %]). Clinical diagnoses include coronary artery disease (78.6%), heart failure (17.3%), and valve repair or replacement (26.4%). Baseline mean 6-minute walk distance was 489.6 (SD, 143.4) meters, daily step count was 6845 (SD, 3353), and exercise minutes was 37.5 (SD, 33.5). In a multivariable model, 6-minute walk distance was significantly associated with age and sex, but not cardiac rehabilitation indication. Sex but not age or cardiac rehabilitation indication was significantly associated with daily step count and exercise minutes.ConclusionsBaseline physical activity varies substantially in low- and moderate-risk patients enrolled in cardiac rehabilitation. Future studies are warranted to explore whether personalizing cardiac rehabilitation programs using mobile health technologies could optimize recovery.RegistrationURL: https://www.Clinicaltrialsgov; Unique identifier: NCT04587882.

Project description:BackgroundPhysical activity is beneficial for cardiovascular rehabilitation. Digitalization suggests using technology in the promotion of physical activity and lifestyle changes. The effectiveness of distance technology interventions has previously been found to be similar to that of conventional treatment, but the added value of the technology has not been frequently studied.ObjectiveThe aim of this pilot study was to investigate whether additional distance technology intervention is more effective in promoting physical activity than non-technology-based treatment in 12 months of cardiac rehabilitation.MethodsThe cardiovascular disease rehabilitation intervention consisted of three 5-day inpatient periods in a rehabilitation center and two 6-month self-exercise periods at home in between. Participants were recruited from among cardiac patients who attended the rehabilitation program and were cluster-randomized into unblinded groups: conventional rehabilitation control clusters (n=3) and similar rehabilitation with additional distance technology experimental group clusters (n=3). Experimental groups used Fitbit Charge HR for self-monitoring, and they set goals and reported their activity using Movendos mCoach, through which they received monthly automated and in-person feedback. Physical activity outcomes for all participants were measured using the Fitbit Zip accelerometer and the International Physical Activity Questionnaire.ResultsDuring the first 6 months, the experimental group (n=29) engaged in light physical activity more often than the control group (n=30; mean difference [MD] 324.2 minutes per week, 95% CI 77.4 to 571.0; P=.01). There were no group differences in the duration of moderate to vigorous physical activity (MD 12.6 minutes per week, 95% CI -90.5 to 115.7; P=.82) or steps per day (MD 1084.0, 95% CI -585.0 to 2752.9; P=.20). During the following 6 months, no differences between the groups were observed in light physical activity (MD -87.9 minutes per week, 95% CI -379.2 to 203.3; P=.54), moderate to vigorous physical activity (MD 70.9 minutes per week, 95% CI -75.7 to 217.6; P=.33), or steps per day (MD 867.1, 95% CI -2099.6 to 3833.9; P=.55).ConclusionsThe use of additional distance technology increased the duration of light physical activity at the beginning of cardiac rehabilitation (for the first 6 months), but statistically significant differences were not observed between the two groups for moderate or vigorous physical activity or steps per day for both 6-month self-exercise periods.Trial registrationISRCTN Registry ISRCTN61225589; https://doi.org/10.1186/ISRCTN61225589.

Project description:BACKGROUND:Internet-based physical activity interventions have great potential in supporting patients in cardiac rehabilitation. Health behavior change theories and user input are identified as important contributors in the effectiveness of the interventions, but they are rarely combined in a systematic way in the design of the interventions. OBJECTIVE:The aim of this study is to identify the appropriate theoretical framework, along with the needs of the users of a physical activity intervention for cardiac rehabilitation, and to combine them into an effective Internet- and mobile-based intervention. METHODS:We explain the theoretical framework of the intervention in a narrative overview of the existing health behavior change literature as it applies to physical activity. We also conducted a focus group with 11 participants of a cardiac rehabilitation program and used thematic analysis to identify and analyze patterns of meaning in the transcribed data. RESULTS:We chose stage-based approaches, specifically the transtheoretical model and the health action process approach as our main framework for tailoring, supplemented with other theoretical concepts such as regulatory focus within the appropriate stages. From the thematic analysis of the focus group data, we identified seven themes: (1) social, (2) motivation, (3) integration into everyday life, (4) information, (5) planning, (6) monitoring and feedback, and (7) concerns and potential problems. The final design of the intervention was based on both the theoretical review and the user input, and it is explained in detail. CONCLUSIONS:We applied a combination of health behavioral theory and user input in designing our intervention. We think this is a promising design approach with the potential to combine the high efficacy of theory-based interventions with the higher perceived usefulness of interventions designed according to user input. TRIAL REGISTRATION:Clinicaltrials.gov NCT01223170; http://clinicaltrials.gov/show/NCT01223170 (Archived by WebCite at http://www.webcitation.org/6M5FqT9Q2).

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:BACKGROUND:Technological interventions such as mobile apps, Web-based social networks, and wearable trackers have the potential to influence physical activity; yet, only a few studies have examined the efficacy of an intervention bundle combining these different technologies. OBJECTIVE:This study aimed to pilot test an intervention composed of a social networking mobile app, connected with a wearable tracker, and investigate its efficacy in improving physical activity, as well as explore participant engagement and the usability of the app. METHODS:This was a pre-post quasi-experimental study with 1 arm, where participants were subjected to the intervention for a 6-month period. The primary outcome measure was the difference in daily step count between baseline and 6 months. Secondary outcome measures included engagement with the intervention and system usability. Descriptive and inferential statistical tests were conducted; posthoc subgroup analyses were carried out for participants with different levels of steps at baseline, app usage, and social features usage. RESULTS:A total of 55 participants were enrolled in the study; the mean age was 23.6 years and 28 (51%) were female. There was a nonstatistically significant increase in the average daily step count between baseline and 6 months (mean change=14.5 steps/day, P=.98, 95% CI -1136.5 to 1107.5). Subgroup analysis comparing the higher and lower physical activity groups at baseline showed that the latter had a statistically significantly higher increase in their daily step count (group difference in mean change from baseline to 6 months=3025 steps per day, P=.008, 95% CI 837.9-5211.8). At 6 months, the retention rate was 82% (45/55); app usage decreased over time. The mean system usability score was 60.1 (SD 19.2). CONCLUSIONS:This study showed the preliminary efficacy of a mobile social networking intervention, integrated with a wearable tracker to promote physical activity, particularly for less physically active subgroups of the population. Future research should explore how to address challenges faced by physically inactive people to provide tailored advices. In addition, users' perspectives should be explored to shed light on factors that might influence their engagement with the intervention.

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