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Promoting Well-being and Health in Heart Failure

A Novel Behavioral Intervention to Promote Adherence in Heart Failure

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 2 visits
  • Time periods mentioned: 1 week, 2 weeks
  • Procedures mentioned: Questionnaires, Pills, Urine samples

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will undergo two visits (in-person or virtual) during which they will meet with study staff."
  • "During the first visit, participants will provide informed consent, answer questionnaires related to psychological and physical health and functioning, have their blood pressure and weight measured, and be asked to monitor their physical activity (using an accelerometer) for one week and medication adherence (using an electronic pill bottle) for two weeks."
  • "Participants will be given a urine collection container and asked to provide a urine sample within 4 hours of their first void and before eating breakfast on the day of Visit 2."
  • "At the second visit, the urine sample will be collected, and upon confirmation of adequate physical activity and medication adherence data, participants will be randomized to receive the PP-MI intervention or the MI-alone intervention."
  • "During these study visits, participants will be asked to answer questionnaires related to psychological and physical health and functioning, have their blood pressure, weight, and waist circumference measured, will perform a 6 minute walk test, and be asked about cardiovascular outcomes, including hospitalizations, cardiovascular procedures, and cardiac-specific hospitalizations."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a 12-week phone program that helps people focus on positive feelings and build healthy habits, plus text messages over 24 weeks. It compares this program with health education and motivational support with a similar amount of attention. It is for adults with class I–III heart failure who have trouble following diet, exercise, or medicine plans.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are an adult with class I, II, or III heart failure, ranging from no symptoms during usual activity to symptoms during light activity.
  • You have trouble following diet, exercise, or medicine plans, shown by a score of 15 or less on three survey questions.

Who can't join

  • You have memory or thinking problems that prevent you from agreeing to join or taking part, based on a 6-question test.
  • You have a medical condition likely to cause death within 6 months.
  • Another medical condition, such as arthritis, prevents you from doing physical activity.
  • You cannot read, write, or speak English.
  • You are already in another program meant to improve well-being or help you follow healthy habits.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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.

Study sites (1)

MA