Gamification for Heart Failure

Overseen By Samantha Coratti

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: End-stage renal disease, Cirrhosis, Cardiac surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

270 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Alexander Fanaroff, MD, MHS

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

Timeline for a Trial Participant

Run-in

Baseline measures of physical activity are obtained

2 weeks

Intervention

Participants engage in a gamified program with social incentives to increase physical activity

6 months

Daily monitoring with wearable device

Follow-up

Participants are monitored for changes in physical activity and functional capacity

3 months

Daily monitoring with wearable device

What Are the Treatments Tested in This Trial?

Interventions

• Gamification plus competition
• Gamification plus social incentive

How Is the Trial Designed?

Group I: Gamification plus social incentive Experimental Treatment 1 Intervention

Participants will receive daily text messages on whether or not they hit their step goal. Participants will be entered into a game, that runs for 6 months. Each week they receive 70 points. If the step goal was met they keep their points. If not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level. If not, they drop a level. They will receive twice-weekly motivational or educational text messages that highlight the effect of exercise on functional capacity in patients with HFpEF. Participants will select a family member or friend who will serve as a support partner. We hold a 3-way phone call with the participant and partner to discuss ways they can help the participant meet their goal. The support partner will receive a weekly email reminding him/her of these approaches and updating him/her on the participant's progress including accumulated points, level in the game, and average step count.

Group II: Gamification plus competition Experimental Treatment 1 Intervention

Participants will receive daily text messages on whether or not they hit their step goal. Participants will be entered into a game, that runs for 6 months. Each week they receive 70 points. If the step goal was met they keep their points. If not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level. If not, they drop a level. They will receive twice-weekly motivational or educational text messages that highlight the effect of exercise on functional capacity in patients with HFpEF. Participants will have access to a leaderboard that will include two other participants. Participants will be ranked on the leaderboard by total points over the course of the study. They will receive a weekly text message with their position on the leaderboard.

Group III: Control Active Control 1 Intervention

In addition to using a wearable device, participants in the control arm will receive a daily notification of their step count from the previous day.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+