MOVE-HF MOtivating Physical Activity With BehaVioral Economics in Heart Failure With Preserved Ejection Fraction

NCT06670001 | Recruiting DMC

• 2 other identifiers: 8559061R01HL174691
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HFpEF - Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• 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.

  9 months

Secondary Outcomes (5)

• Change in mean daily steps from baseline to through the 6-month intervention period

  6 months

• Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score from baseline through the 6-month intervention period

  6 months

• Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score from baseline through the 3-month post-intervention follow-up period

  9 months

• Change in six-minute walk distance from baseline through the 6-month intervention period

  6 months

• Change in six-minute walk distance from baseline through the 3-month post-intervention follow-up period

  9 months

Study Arms (3)

Control

NO 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.

Gamification plus social incentive

EXPERIMENTAL

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.

Behavioral: Gamification plus social incentive

Gamification plus competition

EXPERIMENTAL

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.

Behavioral: Gamification plus competition

Interventions

Gamification plus social incentive BEHAVIORAL

Participants 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 social incentive

Gamification plus competition BEHAVIORAL

Participants in the Gamification plus competition intervention arm will receive gamification and a competition as part of the intervention. See arm descriptions for more detail.

Gamification plus competition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (age ≥ 18 years) who: 1) have a diagnosis of heart failure with preserved ejection; 2) have an ejection fraction ≥ 50%; 3) meet ONE of the following criteria: any history of hospitalization with a primary diagnosis of heart failure with preserved ejection fraction, BNP \> 75 pg/mL (\> 225 pg/mL in patients with atrial fibrillation), H2FPEF score ≥ 5, OR elevated pulmonary capillary wedge pressure on right heart catheterization (≥ 15 mm Hg at rest or ≥ 25 mm Hg with exercise); 4) own a smartphone or tablet capable of connecting to the internet; 5) are able to read English; 6) are able to provide informed consent

You may not qualify if:

• Participants will be excluded if they are currently participating in another interventional physical activity study, have medical conditions prohibiting ambulation without assistance (including use of an assistive device other than a cane) or participation in an exercise program, if a 9-month physical activity program is infeasible or unsafe, upcoming cardiovascular procedures (e.g. stent or surgery) or if the patient is at a high level of physical activity (\>7500 steps per day) or very low level of physical activity (\< 1000 steps/day) at baseline. Patients taking \> 7500 steps/day will be excluded based on data showing that increasing step count beyond 7500 steps/day does not improve outcomes in all-comer populations, and to ensure that we are recruiting a population of patients with symptomatic HF. Patients taking \< 1000 steps/day at baseline will be excluded to ensure that we will not enroll very frail patients with a need for more intensive exercise training or physical therapy. To ensure that we are capturing patients who are limited in their exertional capacity by heart failure, we will also exclude patients with dementia, end-stage renal disease on dialysis, cirrhosis, cardiac surgery or transcatheter valve replacement within the last year, severe aortic stenosis or severe mitral stenosis.

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Study Officials

• Alexander Fanaroff, MD, MHS

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha Coratti

CONTACT

215-746-4372; samantha.coratti@pennmedicine.upenn.edu

Chinyere Anucha

CONTACT

chinyere.anucha@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 1, 2024
• Study Start: June 5, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

US (1)