Promoting Well-being and Health in Heart Failure
Recruiting · NCT04829617 · Interventional (participants receive a specific treatment) · Lead sponsor: Massachusetts General Hospital
View the official record on ClinicalTrials.gov →Interventions studied
MI-alone InterventionPP-MI Intervention
What this trial is about
The focus of this study is to test the efficacy of a 12-week, phone-delivered Positive Psychology-Motivational Interviewing (PP-MI) intervention, with additional twice weekly PP and health behavior text messages for a total of 24 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 12 weeks), compared to an attention-matched MI-based educational condition, in a randomized trial (NIH Stage II) of 280 patients with New York Heart Association class I-III Heart Failure (HF).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Adult patients with NYHA class I, II, or III HF.
- Suboptimal adherence to health behaviors. This will be defined as a total score of ≤15 on three Medical Outcomes Study Specific Adherence Scale (MOS) items regarding diet/exercise/medications.
Exclusion criteria
- Cognitive deficits impeding a participant's ability to provide informed consent or participate, assessed via a 6-item cognitive test.
- Medical conditions likely to lead to death within 6 months.
- Inability to participate in physical activity due to another medical condition (e.g., arthritis).
- Inability to read, write, or speak in English.
- Current participation in another intervention or program that has been designed to promote well-being or health behavior adherence.
Where it is running
1 location listed across 1 US state.
- Massachusetts General Hospital - Boston, Massachusetts, United States