Researching Emotions And Cardiac Health: Phase III — REACH III  

Congestive Heart Failure Clinical Trial

Official title: A Positive Psychology Intervention to Promote Health Behaviors in Heart Failure: a Randomized, Controlled Pilot Trial

Status Completed

Clinical Trial Summary

The focus of this study is to examine the feasibility, acceptability, and preliminary impact of a 12-week, telephone-delivered, positive psychology (PP)-based health behavior intervention in a group of patients with mild to moderate heart failure (HF), compared to a motivational interviewing- (MI-) based education condition and treatment as usual (TAU).

Clinical Trial Description

The investigators are proposing a study that will focus on the implementation of a novel PP-based health behavior intervention that is adapted for patients with HF. The MGH inpatient units, MGH Heart Center, and MGH primary care clinic outpatients will serve as the source of participants for the study, with patients who have a diagnosis of HF serving as potential participants. The investigators will enroll 60 HF patients, who will take part in a 12-week PP-based health behavior intervention.

In this project, the investigators hope to do the following:

1. Test a 12-week, telephone-delivered health behavior intervention utilizing PP exercises and systematic goal-setting in a three-arm, randomized, controlled pilot trial in patients with mild to moderate HF (N=60).

2. Determine whether this optimized intervention is feasible in a small cohort of HF patients.

3. Explore potential benefits of the intervention on outcomes of interest (e.g., psychological health, functioning, and health behavior adherence) compared to a motivational interviewing- (MI) based education condition and treatment as usual (TAU).

Baseline information about enrolled participants will be obtained from the patients, care providers, and the electronic medical record as required for characterization of our population. This information will include data regarding medical history (history of prior acute coronary syndrome, coronary artery disease, coronary artery bypass graft, congestive HF, hypertension, diabetes mellitus, hyperlipidemia, and current smoking), current medical variables (renal function, left ventricular ejection fraction, NYHA class), medications, and sociodemographic data (age, gender, race/ethnicity, living alone).

Participants will undergo two in person visits during which they will meet with study staff in person (or if preferred over the phone). In their first visit, they will answer questionnaires related to psychological and physical health and functioning and will be asked to wear an accelerometer for one week to measure their baseline physical activity. At their second in-person visit, they will be randomized to receive (1) the PP-based health behavior intervention, (2) the MI-based educational condition, or (3) TAU. Participants in the TAU group will not receive any additional intervention but will complete follow-up phone calls at 12 and 24 weeks.

Following randomization, participants in the two treatment groups will be provided a treatment manual corresponding with their treatment condition with weekly exercises, along with a copy of the Learning to Live with Heart Failure guide. The appropriate intervention will be introduced, and the first exercise will be assigned. Finally, participants in both treatment groups will receive a personal step counter to use over the course of the study.

Following the second in-person visit, participants in the PP-based intervention and MI-based control condition groups will complete twelve 30- to 45-minute 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.

At Weeks 12 and 24, a member of the study staff will call participants to repeat the self-report questionnaires that were administered at baseline. At these two time points, participants also will be asked to wear an accelerometer for an additional 7 days to measure physical activity. ;

Related Conditions & MeSH terms

• Congestive Heart Failure
• Emotions
• Heart Failure
• Patient Compliance

• NCT number: NCT03220204
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Completion date: September 9, 2019