RECRUITING

Medication Adherence Program

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

Randomized controlled trial testing the efficacy of the Supporting Tailored Adaptive change and Reinforcement for Medication Adherence Program (STAR-MAP), a health coaching approach that aims to improve antihypertensive medication adherence, blood pressure control, and quality of life. Participants (n=402) \>=40 years old with a diagnosis of hypertension, uncontrolled blood pressure, and low antihypertensive medication adherence will be recruited through a statewide health insurer, Blue Cross Blue Shield of Louisiana, and randomized to receive either interactive health coaching sessions with medication reminder tools (intervention) or medication reminder tools only (control) over one year. Data will be collected from participants at baseline, 6 months, 12 months, and 24 months using questionnaires, physical measurement (height, weight, blood pressure), a computer-based single-category implicit association test, and laboratory analysis of antihypertensive medication urinary metabolites.

Official Title

Supporting Tailored Adaptive Change and Reinforcement for Medication Adherence Program: Randomized Trial of a Novel Approach to Improve Adherence in Older Hypertensive Women and Men

Quick Facts

Study Start:2022-03-07
Study Completion:2027-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05183763

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:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * fully insured by Blue Cross Blue Shield of Louisiana (BCBSLA)
  2. * continuously enrolled in BCBSLA for one year
  3. * planning to remain a member of BCBSLA for next year
  4. * English-speaking
  5. * telephone access
  6. * aged ≥40 years
  7. * diagnosis of essential hypertension (ICD-10-CM code I10)
  8. * currently filling antihypertensive medication
  9. * low antihypertensive medication refill (proportion of days covered (PDC) \<0.8)
  10. * low self-report adherence (4-item Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4) score ≥1)
  11. * uncontrolled blood pressure (BP) (systolic BP ≥130 mm Hg or diastolic BP ≥80 mm Hg)
  12. * desire to improve BP
  1. * living in a household with someone already enrolled in the study
  2. * enrollment in another clinical trial for drug adherence or BP control
  3. * moderate to severe cognitive impairment

Contacts and Locations

Study Contact

Erin M Peacock, PhD, MPH
CONTACT
504-988-1075
epeacoc@tulane.edu
Marie A Krousel-Wood, MD, MSPH
CONTACT
504-988-7056
mawood@tulane.edu

Principal Investigator

Marie A Krousel-Wood, MD, MSPH
PRINCIPAL_INVESTIGATOR
Tulane University

Study Locations (Sites)

Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
United States
Tulane Doctors Dermatology & Multispecialty Clinic
Covington, Louisiana, 70433
United States
Tulane Doctors Heart & Vascular and Primary Care Clinic
Metairie, Louisiana, 70002
United States
Tulane University Clinical and Translational Unit
New Orleans, Louisiana, 70112
United States
LSU Health Sciences Shreveport Clinical Trials Office
Shreveport, Louisiana, 71101
United States

Collaborators and Investigators

Sponsor: Tulane University

  • Marie A Krousel-Wood, MD, MSPH, PRINCIPAL_INVESTIGATOR, Tulane University

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 Date2022-03-07
Study Completion Date2027-04-30

Study Record Updates

Study Start Date2022-03-07
Study Completion Date2027-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Hypertension
  • Medication Adherence
  • Behavior and Behavior Mechanisms