RecruitingNot ApplicableNCT05183763

Medication Adherence Program

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


Sponsor

Tulane University

Enrollment

402 participants

Start Date

Mar 7, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 40 Years

Inclusion Criteria12

  • fully insured by Blue Cross Blue Shield of Louisiana (BCBSLA)
  • continuously enrolled in BCBSLA for one year
  • planning to remain a member of BCBSLA for next year
  • English-speaking
  • telephone access
  • aged ≥40 years
  • diagnosis of essential hypertension (ICD-10-CM code I10)
  • currently filling antihypertensive medication
  • low antihypertensive medication refill (proportion of days covered (PDC) \<0.8)
  • low self-report adherence (4-item Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4) score ≥1)
  • uncontrolled blood pressure (BP) (systolic BP ≥130 mm Hg or diastolic BP ≥80 mm Hg)
  • desire to improve BP

Exclusion Criteria3

  • living in a household with someone already enrolled in the study
  • enrollment in another clinical trial for drug adherence or BP control
  • moderate to severe cognitive impairment

Interventions

BEHAVIORALSTAR-MAP health coaching

Interactive health coaching delivered in 11 sessions over one year; focusing on using adaptive change tactics to improve medication-taking behavior

BEHAVIORALMedication reminder tools

Medication-taking reminder app and pillbox


Locations(5)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Tulane Doctors Dermatology & Multispecialty Clinic

Covington, Louisiana, United States

Tulane Doctors Heart & Vascular and Primary Care Clinic

Metairie, Louisiana, United States

Tulane University Clinical and Translational Unit

New Orleans, Louisiana, United States

LSU Health Sciences Shreveport Clinical Trials Office

Shreveport, Louisiana, United States

View Full Details on ClinicalTrials.gov

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NCT05183763


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