A Novel Behavioral Intervention to Promote Adherence in Heart Failure

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Christohper M Celano, MD
ccelano@partners.org
617-726-6485
Time Frame
Start Date: 2021-11-29
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 280
Treatments
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).
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).
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov