Promoting Well-being and Health in Heart Failure
Purpose
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).
Conditions
- Heart Failure
- Heart Failure NYHA Class I
- Heart Failure NYHA Class II
- Heart Failure NYHA Class III
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Randomized, single-blinded, controlled trial
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
- Masking Description
- Participants and treating study staff will be aware of the participant's treatment condition. However, follow-up assessments will be performed by a study staff member that is masked to the participant's treatment condition.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental PP-MI Intervention |
Participants will receive a 12-week, Positive Psychology-Motivational Interviewing (PP-MI) intervention. Each week, participants will complete a PP activity and work towards one or more health behavior goals, then complete a phone session with a study trainer. Each weekly session will include PP and goal setting portions. In the PP portion, a study trainer will (a) review the week's PP exercise, (b) discuss the rationale of the next week's PP exercise through a guided review of the PP-MI manual, and (c) assign the next week's PP exercise. Additionally for the goal-setting portion, the trainer will (a) review their goals and health behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week. Finally, participants will receive supplemental text messages throughout the 12 weeks of the intervention and during the initial follow-up period (Week 13-24). |
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|
Active Comparator MI-alone Intervention |
This condition will mirror the MI component of the PP-MI intervention. During the first three sessions, participants will learn about the causes and types of HF, risk factors for cardiovascular disease, and methods for monitoring risk factors and symptoms. Then participants will complete nine sessions related to physical activity, a low sodium diet, and medication adherence. Weekly tasks (e.g., brainstorming barriers) will be assigned, completed between calls, and reviewed at the following call. Finally, participants will receive supplemental text messages throughout the 12 weeks of the intervention and during the initial follow-up period (Week 13-24). |
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Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
Detailed Description
The investigators are proposing a study that will focus on testing the efficacy of a 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) in patients with New York Heart Association class I-III HF. The investigators will enroll 280 HF patients, who will take part in a 12-week (with 24 weeks of supplemental text messages) health behavior intervention. In this project, the investigators hope to do the following: 1. Examine the efficacy of a 12-week, phone-delivered PP-MI intervention for individuals with heart failure (HF) on health behavior adherence at 12 weeks (primary time point), 24 weeks, and 48 weeks. 2. Assess the intervention's impact on psychological outcomes, health-related quality of life (HRQoL), HF-specific quality of life, HF symptoms, and function. 3. Explore the intervention's impact on markers of cardiovascular health (e.g., blood pressure), as well as major adverse cardiac events, HF hospitalizations, and mortality. Participants will undergo two visits (in-person or virtual) during which they will meet with study staff. During the first visit, participants will provide informed consent, answer questionnaires related to psychological and physical health and functioning, have their blood pressure and weight measured, and be asked to monitor their physical activity (using an accelerometer) for one week and medication adherence (using an electronic pill bottle) for two weeks. Participants will be given a urine collection container and asked to provide a urine sample within 4 hours of their first void and before eating breakfast on the day of Visit 2. At the second visit, the urine sample will be collected, and upon confirmation of adequate physical activity and medication adherence data, participants will be randomized to receive the PP-MI intervention or the MI-alone intervention. Following randomization, all participants will be provided a treatment manual corresponding with their treatment condition, a Fitbit activity tracker, and other treatment materials. The appropriate intervention will be introduced, and the first exercise will be assigned. Following the second visit, participants in both treatment conditions will complete twelve weekly phone sessions with a study trainer. The phone sessions primarily will include a review of the prior week's session content and a discussion of the rationale and assignment of the next week's exercise/assignment. Participants in both treatment conditions will receive twice weekly text messages throughout the intervention (Weeks 1-12) and initial follow-up period (Weeks 13-24). During the intervention, these messages will provide information about the PP activity (PP-MI group) and health behavior goal (both groups) discussed that week. During Weeks 13-24, participants in the PP-MI condition will engage with twice weekly, automated, interactive text messages related to PP and health behavior goals. Individuals in the MI-alone group will receive identical messages related to setting health behavior goals as the PP-MI participants and will additionally receive a fixed test message providing education about health behavior adherence. At Weeks 12, 24, and 48, participants will complete follow-up visits. One week prior to these visits, participants will be mailed an accelerometer and will wear it until their study visit. They will also be sent a container for urine collection, which they will bring to their follow-up visit. During these study visits, participants will be asked to answer questionnaires related to psychological and physical health and functioning, have their blood pressure, weight, and waist circumference measured, will perform a 6 minute walk test, and be asked about cardiovascular outcomes, including hospitalizations, cardiovascular procedures, and cardiac-specific hospitalizations. Finally, participants will complete phone sessions every 6 months until study end to inquire about hospitalizations and adverse cardiac events.