Promoting Well-being and Health in Heart Failure

NCT04829617 | Recruiting DMC

• 1 other identifier: 2021P000882
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Keywords

Positive Psychology; Physical Activity; Low-Sodium Diet; Medication Adherence; Motivational Interviewing

Outcome Measures

Primary Outcomes (1)

• Health behavior adherence

  Composite score of overall activity (measured by accelerometer in steps/day), sodium excretion (urine sodium in mEq/day), and medication adherence (Medication Event Monitoring System \[MEMS\] electronic pill bottle). This composite score will be created by calculating z scores for each individual outcome measure and then averaging them for each participant at each time point.

  Baseline, 12 Weeks, 24 Weeks, 48 Weeks

Secondary Outcomes (5)

• Physical activity (in steps/day)

  Measured for 7 days at baseline, 12 weeks, 24 weeks, and 48 weeks

• Objective medication adherence (Medication Event Monitoring System [MEMS] pill bottles)

  Measured for 14 days at baseline, 12 weeks, 24 weeks, and 48 weeks

• Sodium Excretion (mEq/day)

  Baseline, 12 weeks, 24 weeks, 48 weeks

• Positive Affect (Positive and Negative Affect Schedule [PANAS] positive affect items)

  Baseline, 12 weeks, 24 weeks, 48 weeks

• Physical Function (PROMIS 20-item Physical Function Short Form [PF-20])

  Baseline, 12 weeks, 24 weeks, 48 weeks

Other Outcomes (23)

• Moderate to Vigorous Physical Activity (MVPA)

  Measured for 7 days at baseline, 12 weeks, 24 weeks, and 48 weeks

• Sedentary Time (mean minutes/day)

  Measured for 7 days at baseline, 12 weeks, 24 weeks, and 48 weeks

• Self-reported sodium intake (Scored Sodium Questionnaire [SSQ])

  Baseline, 12 weeks, 24 weeks, 48 weeks

Study Arms (2)

PP-MI Intervention

EXPERIMENTAL

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).

Behavioral: PP-MI Intervention

MI-alone Intervention

ACTIVE COMPARATOR

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).

Behavioral: MI-alone Intervention

Interventions

PP-MI Intervention BEHAVIORAL

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.

PP-MI Intervention

MI-alone Intervention BEHAVIORAL

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.

MI-alone Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure; Motor Activity; Medication Adherence

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Christopher M Celano, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christohper M Celano, MD

CONTACT

617-726-6485; ccelano@partners.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist

Model Details: Randomized, single-blinded, controlled trial

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 2, 2021
• Study Start: November 29, 2021
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: This information will be shared prior to the end of the study funding period.
• Access Criteria: Investigators who are interested in obtaining access to this information will be asked to submit a request to the principal investigator outlining the proposed use of the data and would need to agree to certain conditions (e.g., not attempting to identify individual participants, destroying data once the use of the data is complete) prior to obtaining access.

Locations

US (1)