RecruitingNot ApplicableNCT04829617

Promoting Well-being and Health in Heart Failure

A Novel Behavioral Intervention to Promote Adherence in Heart Failure

Sponsor

Massachusetts General Hospital

Enrollment

280 participants

Start Date

Nov 29, 2021

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 Years

Inclusion Criteria2

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 Criteria5

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.

Interventions

BEHAVIORALPP-MI Intervention

The 12-week PP-MI intervention focuses on enhancing well-being (through PP) and promoting adherence to physical activity, diet, and medications (through MI). 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. The PP portion of the program will focus on the cultivation of well-being through the performance of easy-to complete activities (e.g., using a strength in a new way) and review of the positive feelings they generate. The MI portion of the program will focus on assisting participants to monitor health behavior adherence, resolve ambivalence to behavior change, set realistic health behavior goals, problem-solve barriers, and identify resources to complete behavior change. Finally, participants will receive twice weekly text messages (for 24 weeks) to encourage completion of PP activities and engagement in health behaviors.

BEHAVIORALMI-alone Intervention

The time- and attention-matched MI-alone intervention focuses on providing education about heart failure (HF) and promoting adherence to physical activity, diet, and medications. Each week, participants will independently complete an activity related to HF education or adherence to a health behavior, then complete a phone session with a study trainer. HF educational topics will include the causes and types of HF, risk factors for cardiovascular disease, methods for monitoring risk factors and symptoms, and the importance of adherence to physical activity, diet, and medications. For each health behavior, study trainers will assist participants to monitor adherence, identify realistic behavior goals, problem-solve barriers, and identify resources to complete behavior change. Finally, participants will receive twice weekly text messages (for 24 weeks) that provide education and encourage engagement in health behaviors.