NCT04829617 Promoting Well-being and Health in Heart Failure
| NCT ID | NCT04829617 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 280 participants |
| Start Date | 2021-11-29 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 280 participants in total. It began in 2021-11-29 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility 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.
Contact & Investigator
Christopher M Celano, MD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT04829617 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04829617 currently recruiting?
Yes, NCT04829617 is actively recruiting participants. Contact the research team at ccelano@partners.org for enrollment information.
Where is the NCT04829617 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT04829617 clinical trial?
NCT04829617 is sponsored by Massachusetts General Hospital. The principal investigator is Christopher M Celano, MD at Massachusetts General Hospital. The trial plans to enroll 280 participants.
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