Promoting Well-being and Health in Heart Failure

Heart Failure Clinical Trial

Official title: A Novel Behavioral Intervention to Promote Adherence in Heart Failure

Status Recruiting

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure NYHA Class I
• Heart Failure NYHA Class II
• Heart Failure NYHA Class III

• NCT number: NCT04829617
• Study type: Interventional
• Source: Massachusetts General Hospital
• Contact: Christohper M Celano, MD
• Phone: 617-726-6485
• Email: ccelano@partners.org
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2021
• Completion date: June 30, 2026