About this trial
This is a three-arm, randomized, controlled trial to test the effectiveness of gamification plus a social incentive - either social support or competition - to increase adherence to physical activity among individuals with HFpEF. There will be a 2-week run-in period to obtain baseline measures of physical activity, followed by a 6-month intervention period and then a 3-month follow-up period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Gamification plus social incentive
BehavioralParticipants in the Gamification plus social incentive intervention arm will receive gamification and social incentives as part of the intervention. See arm descriptions for more detail.
Gamification plus competition
BehavioralParticipants in the Gamification plus competition intervention arm will receive gamification and a competition as part of the intervention. See arm descriptions for more detail.
Treatment groups
Trial outcomes
Primary outcomes
The primary outcome is the change in mean daily step counts from baseline through the 3-month post-intervention follow-up period.
The primary outcome is the change in mean daily step counts from baseline through the 3-month post-intervention follow-up period.
Secondary outcomes
Change in mean daily steps from baseline to through the 6-month intervention period
Change in mean daily steps from baseline to through the 6-month intervention period
Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score from baseline through the 6-month intervention period
Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score from baseline through the 6-month intervention period
Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score from baseline through the 3-month post-intervention follow-up period
Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score from baseline through the 3-month post-intervention follow-up period
Change in six-minute walk distance from baseline through the 6-month intervention period
Change in six-minute walk distance from baseline through the 6-month intervention period
Sponsors and contacts
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University of Pennsylvania
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator