ACTIVE_NOT_RECRUITING

Healthy Heart Habits-2

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Conditions

Acute Coronary Syndrome

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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

Sixty adults who have experienced acute coronary syndrome within the past 2-12 months from three states (Rhode Island, North Carolina, Minnesota) will be randomized to either (1) a coaching program for depressed mood and health behavior change (Behavioral Activation for Health and Depression; BA-HD), or (2) Enhanced Usual Care. This study will evaluate the feasibility and acceptability of study procedures and BA-HD, and establish protocol and measurement harmonization across three sites in preparation for a future multi-site efficacy trial.

Official Title

Multisite Feasibility of BA-HD: An Integrated Depression and Behavioral Risk Factor Reduction Coaching Program Following Acute Coronary Syndrome

Quick Facts

Study Start:2024-06-13
Study Completion:2026-07-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06440278

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 to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Medical chart-documented ACS (diagnosis of unstable angina, ST or non-ST elevation myocardial infarction) occurrence within the past 2-12 months.
  2. * Post-ACS depressed mood defined as a Patient Health Questionnaire(PHQ)--9 score ≥ 10 upon screening,
  3. * Non-adherence to and willingness to implement changes to ≥1 health behavior based on screening of:
  4. 1. Smoking/Tobacco exposure,
  5. 2. Physical Activity,
  6. 3. Diet,
  7. 4. Sleep health,
  8. 5. Medication adherence
  9. * English-language fluency
  10. * Resides within 90 minutes (driving time) of each site with no plans to relocate beyond that range during study participation
  11. * Access to a telephone and/or videoconferencing capability
  12. * Has primary care provider
  13. * Address at which packages can be received
  1. * Chart indication of significant cognitive impairment (e.g., chart-documented dementia), Current exacerbation of serious mental illness,
  2. * Suicidality,
  3. * Hearing impairment that prevents telephone/video communication for intervention and assessment purposes,
  4. * Current hospice care, and
  5. * Current engagement in cardiac rehabilitation or other regular counseling treatment targeting depression or health behavior change

Contacts and Locations

Principal Investigator

Emily Gathright, PhD
PRINCIPAL_INVESTIGATOR
The Miriam Hospital
Andrew Busch, PhD
PRINCIPAL_INVESTIGATOR
Hennepin Healthcare Research Institute

Study Locations (Sites)

Hennepin Healthcare Research Institute
Minneapolis, Minnesota, 55415
United States
ECU Health
Greenville, North Carolina, 27835
United States
The Miriam Hospital
Providence, Rhode Island, 02903
United States

Collaborators and Investigators

Sponsor: The Miriam Hospital

  • Emily Gathright, PhD, PRINCIPAL_INVESTIGATOR, The Miriam Hospital
  • Andrew Busch, PhD, PRINCIPAL_INVESTIGATOR, Hennepin Healthcare Research Institute

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 Date2024-06-13
Study Completion Date2026-07-15

Study Record Updates

Study Start Date2024-06-13
Study Completion Date2026-07-15

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Coronary Syndrome