Heart Failure
Conditions
Keywords
Physical activity, Digital health, Mobile Health, Artificial Intelligence
Brief summary
Physical activity is known to help patients with heart failure feel better and live longer though few patients with heart failure are sufficiently active. This study is evaluating whether a mobile health intervention can help patients with heart failure increase physical activity levels and remain active over time. The mobile health intervention consists of three parts: Notifications encouraging physical activity, a digital health coach trained in motivational interviewing, and a mobile application which encourages goal setting and activity monitoring.
Detailed description
Hypotheses: 1. Push notifications as part of a mobile health intervention will increase immediate (4 hour) physical activity levels among participants with heart failure. 2. A multicomponent mobile health intervention will increase physical activity levels at 3 months among participants with heart failure. 3. An artificial intelligence (AI) based health coach promoting physical activity will be safe among participants with heart failure.
Interventions
BEHAVIORALMobile application intervention
Following a baseline period, participants will receive a 12 week mobile health intervention consisting of 3 main components: (1) a mobile application which supports goal-setting and self-monitoring; (2) an artificial intelligence (AI)-based health coach within the mobile application trained in principles of motivational interviewing and tailored to the needs of patients with heart failure (3) micro-randomized messages designed to enhance perceived competence around physical activity and promoting low level physical activity.
Sponsors
University of Michigan
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Michigan Medicine patient with a diagnosis of heart failure (HF) * Age 18 years and older at screening and able to provide consent * New York Heart Association class 2 or 3 HF symptoms * Safe for home physical activity as determined by treating clinician * Own a smartphone with a compatible Apple or Android operating system * Fluent in spoken and written English
Exclusion criteria
* Hospitalized for HF within the prior 6 weeks * Orthopedic or neurological condition significantly limiting physical activity * Greater than mild cognitive impairment * Enrolled in hospice care * Severe valvular stenosis * Exercise-induced ventricular tachycardia * Obstructive left main or proximal left anterior descending coronary artery disease * Pulmonary hypertension treated with inhaled or intravenous therapy * Currently pregnant or planning to become pregnant * Determined to be unsafe for participation as assessed by the investigative team.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Step count 4 hours after a decision point for micro-randomized messages | 4 hours after a decision point |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean daily step count from baseline to 3 months | Baseline, 3 months | Participants will wear a Fitbit activity tracker for the duration of the study |
| Percentage of transcripts with a recommendation that is deemed unsafe by the study team | 3-month intervention | AI-based health coaching conversations determined to be unsafe based on study team review. |
| Changes in autonomous motivation from baseline to 3 months on the Behavioral Regulation in Exercise Questionnaire version 3 (BREQ-3) | Baseline, 3 months | The BREQ-3 is a widely used measure of the continuum of behavioral regulation in exercise psychology research. The BREQ-3 is 24 questions and the score ranges from 0-4 with higher scores indicating a greater level of endorsement of autonomous motivation. It will be measured at 2 time points. Autonomous motivation will be calculated by combining the identified, integrated, and intrinsic regulation subscales of the BREQ-3. |
| Change in controlled motivation from baseline to 3 months on the Behavioral Regulation in Exercise Questionnaire version 3 (BREQ-3). | Baseline, 3 months | The BREQ-3 is a widely used measure of the continuum of behavioral regulation in exercise psychology research. The BREQ-3 is 24 questions and the score ranges from 0-4 with higher scores indicating a greater level of endorsement of controlled motivation. It will be measured at 2 time points. Autonomous motivation will be calculated by combining the identified, integrated, and intrinsic regulation subscales of the BREQ-3. |
| Change in mean daily step count by week over the study duration | Weekly up to 3 months (intervention period) | — |
Countries
United States
Contacts
CONTACTChelsie Gesierich, MPH
PRINCIPAL_INVESTIGATORJessica Golbus, MD, MS
University of Michigan
Outcome results
None listed