RECRUITING

Promoting Well-being and Health in Heart Failure

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Novel Behavioral Intervention to Promote Adherence in Heart Failure

Quick Facts

Study Start:2021-11-29
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04829617

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients with NYHA class I, II, or III HF.
  2. * 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.
  1. * Cognitive deficits impeding a participant's ability to provide informed consent or participate, assessed via a 6-item cognitive test.
  2. * Medical conditions likely to lead to death within 6 months.
  3. * Inability to participate in physical activity due to another medical condition (e.g., arthritis).
  4. * Inability to read, write, or speak in English.
  5. * Current participation in another intervention or program that has been designed to promote well-being or health behavior adherence.

Contacts and Locations

Study Contact

Christohper M Celano, MD
CONTACT
617-726-6485
ccelano@partners.org

Principal Investigator

Christopher M Celano, MD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Christopher M Celano, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-29
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2021-11-29
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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