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

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

Plain Language Summary

Simplified for easier understanding

This study is testing a program to help heart failure patients improve their day-to-day health habits — including diet, exercise, and taking medications as prescribed. Researchers are testing whether a well-being and behavior change intervention can help people with heart failure manage their condition better. **You may be eligible if...** - You are an adult with heart failure at a mild to moderate stage (NYHA class I, II, or III) - You score low on a test of health behavior adherence (meaning you are not consistently following recommended diet, exercise, or medication habits) - You are able to read, write, and speak English **You may NOT be eligible if...** - You have significant cognitive problems that would prevent you from giving consent or participating - You are expected to live less than 6 months due to other medical conditions - You cannot do physical activity due to another condition (e.g., severe arthritis) - You are currently in another wellness program Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT04829617


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