HFpEF - Heart Failure With Preserved Ejection Fraction
Conditions
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.
Detailed description
Heart failure (HF) with preserved ejection fraction (HFpEF), a syndrome characterized by exercise intolerance due to breathlessness and fatigue, is a major public health problem rising in prevalence. No pharmacologic strategy has been shown to consistently improve functional capacity of HFpEF patients, though exercise training is beneficial. However, reimbursement barriers and access limitations preclude widespread implementation of cardiac rehabilitation. Despite the association between increased physical activity, lower HF hospitalization, and improved quality of life, physical activity levels remain dismally low in HF patients. 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. All participants will be asked to use the wearable device during the day every day during the intervention and follow-up periods. The three interventions by study arm will vary as follows: Control, Gamification plus social incentive which includes; Pre commitment, support partner, a game using; points, levels, fresh starts, trophies and automated coaching. Competition arm which includes; Pre commitment, a game using; points, levels, fresh starts, trophies and automated coaching and a competition with other participants and access to the leadership board.
Interventions
BEHAVIORALGamification plus social incentive
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.
BEHAVIORALGamification plus competition
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome is the change in mean daily step counts from baseline through the 3-month post-intervention follow-up period. | 9 months | The primary outcome is the change in mean daily step counts from baseline through the 3-month post-intervention follow-up period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean daily steps from baseline to through the 6-month intervention period | 6 months | 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 | 6 months | 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 | 9 months | 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 | 6 months | Change in six-minute walk distance from baseline through the 6-month intervention period |
| Change in six-minute walk distance from baseline through the 3-month post-intervention follow-up period | 9 months | Change in six-minute walk distance from baseline through the 3-month post-intervention follow-up period |
Countries
United States
Contacts
Primary ContactSamantha Coratti
Backup ContactChinyere Anucha
Outcome results
None listed