Improving well-being and health in heart failure patients
A Novel Behavioral Intervention to Promote Adherence in Heart Failure
This study is testing a new phone-based program that combines positive psychology and motivational support to see if it can help heart failure patients improve their health and well-being over six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04829617 on ClinicalTrials.gov |
What this trial studies
This study tests a 12-week phone-delivered Positive Psychology-Motivational Interviewing (PP-MI) intervention, supplemented by health behavior text messages over 24 weeks, for patients with New York Heart Association class I-III heart failure. The goal is to evaluate the intervention's effectiveness on health behavior adherence, psychological outcomes, and cardiovascular health markers. Participants will engage in two visits for assessments and monitoring, with a focus on improving quality of life and reducing hospitalizations.
Who should consider this trial
Good fit: Ideal candidates are adults with NYHA class I, II, or III heart failure who struggle with adherence to health behaviors.
Not a fit: Patients with cognitive deficits, severe medical conditions, or those currently engaged in similar interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance health behaviors and overall well-being in heart failure patients, potentially leading to better health outcomes.
How similar studies have performed: Other studies have shown promise in using motivational interviewing and positive psychology approaches for improving health outcomes, suggesting this intervention could be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Christopher M Celano, MD — Massachusetts General Hospital
- Study coordinator: Christohper M Celano, MD
- Email: ccelano@partners.org
- Phone: 617-726-6485
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.