Mobile Health Intervention to Increase Activity in Heart Failure Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mobile application intervention.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
MObile Health Intervention to INcrease Activity in Heart Failure Study: A Micro-Randomized Trial
Overview
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
- Behavioral Mobile 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 promotin
Primary outcome measures
- Step count 4 hours after a decision point for micro-randomized messages [Time frame: 4 hours after a decision point]
Secondary outcome measures (5)
- Change in mean daily step count from baseline to 3 months [Time frame: Baseline, 3 months]
- Percentage of transcripts with a recommendation that is deemed unsafe by the study team [Time frame: 3-month intervention]
- Changes in autonomous motivation from baseline to 3 months on the Behavioral Regulation in Exercise Questionnaire version 3 (BREQ-3) [Time frame: Baseline, 3 months]
- Change in controlled motivation from baseline to 3 months on the Behavioral Regulation in Exercise Questionnaire version 3 (BREQ-3). [Time frame: Baseline, 3 months]
- Change in mean daily step count by week over the study duration [Time frame: Weekly up to 3 months (intervention period)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Michigan — Ann Arbor
Identifiers
NCT: NCT07750262 · HUM00290190 · K23HL168220-01