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 trial aims to determine if a game-like approach (gamification), combined with social support or competition, can help individuals with heart failure with preserved ejection fraction (HFpEF) maintain a regular physical activity routine. Participants will either receive support from a chosen partner or compete with fellow participants to achieve step goals. It is ideal for those diagnosed with HFpEF, who own a smartphone or tablet, and can walk unaided. As an unphased trial, this study provides a unique opportunity to explore innovative methods to improve health and contribute to valuable research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that adding game-like elements to everyday activities, known as gamification, can effectively increase physical activity. Studies indicate that these methods help people with heart conditions stay active without major safety concerns.

In the Gamification plus competition treatment, research has found that gamification, especially when paired with friendly competition, motivates people to be more active. This approach has successfully encouraged physical activity in those with heart issues, with no significant safety problems reported.

In the Gamification plus social incentive treatment, studies highlight the benefits of adding social support to gamification. Involving friends or family helps participants stay motivated, leading to better health outcomes. Again, no major safety issues have been noted with this method.

Both strategies aim to increase physical activity, which is generally safe and beneficial for heart health. Since this trial is not in an early phase, the safety of these approaches appears well-established. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they leverage gamification and social dynamics to engage patients with heart failure in a new way. Unlike traditional treatments that focus on medications or lifestyle advice, these approaches use games and competition to motivate increased physical activity. The "Gamification plus social incentive" arm involves support from family or friends, providing a personal touch to help patients stick to their goals. On the other hand, the "Gamification plus competition" arm introduces a competitive edge with a leaderboard to boost motivation. These innovative strategies aim to make exercise a more engaging and consistent part of patients' lives, potentially improving their health outcomes in a fun and interactive manner.

What evidence suggests that this trial's treatments could be effective for heart failure?

Studies have shown that game-like elements can boost physical activity, crucial for managing heart failure with preserved ejection fraction (HFpEF). Research indicates that walking just 500 extra steps daily can reduce the risk of heart-related death by 7%. In this trial, one treatment arm involves gamification with competition, allowing participants to track progress on a leaderboard. Another treatment arm uses gamification with social incentives, encouraging friends or family to support participants in reaching activity goals. Both methods aim to promote exercise, known to improve heart health and lower risks. ^{1 2 4 6 7}

Who Is on the Research Team?

Alexander Fanaroff, MD, MHS

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for individuals with diastolic heart failure, also known as heart failure with preserved ejection fraction (HFpEF). Participants should be willing to increase their physical activity and adhere to the study's requirements over a period of 9 months.

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

Trial Overview The trial examines if adding game-like elements ('gamification') plus social incentives—either support from friends/family or competition—can help people with HFpEF stick to an exercise routine. It's a three-part study: first, there's a two-week observation phase, then six months of intervention, followed by three months of follow-up.

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+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. ctv.veeva.com ctv.veeva.com/study/game-hfpef-heart-failure-with-preserved-ejection-fraction

MOVE-HF MOtivating Physical Activity With BehaVioral ... This is a three-arm, randomized, controlled trial to test the effectiveness of gamification plus a social incentive - either social support or ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06670001?term=AREA%5BBasicSearch%5D(STEP-HFpEF)&rank=8

MOVE-HF MOtivating Physical Activity With BehaVioral ... This is a three-arm, randomized, controlled trial to test the effectiveness of gamification plus a social incentive - either social support or competition ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.069531

Effect of Gamification, Financial Incentives, or Both to ... In observational studies, increased physical activity is associated with a lower risk of all-cause mortality and major adverse cardiovascular ...

4. withpower.com withpower.com/trial/phase-heart-failure-1-2025-6db1c

Gamification for Heart Failure This is a three-arm, randomized, controlled trial to test the effectiveness of gamification plus a social incentive - either social support or competition ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11806271/

Effectiveness of Mobile Health–Based Gamification ... Banach et al [52] found that an increase of just 500 steps per day was linked to a 7% reduction in cardiovascular mortality. Based on the PI, in a new study, ...

6. researchgate.net researchgate.net/publication/379654245_Effect_of_Gamification_Financial_Incentives_or_Both_to_Increase_Physical_Activity_Among_Patients_at_High_Risk_of_Cardiovascular_Events_The_BE_ACTIVE_Randomized_Controlled_Trial

Effect of Gamification, Financial Incentives, or Both to ... Lifestyle modification with weight loss and physical activity can improve risk factors and functional outcomes in HFpEF. We sought to observe daily physical ...

7. researchprotocols.org researchprotocols.org/2023/1/e45801/

Sensor-Controlled Digital Game for Heart Failure Self- ... This randomized clinical trial aims to assess the efficacy of a SCDG in integrating the behavioral data of participants with HF from weight scale and activity ...