Medication Adherence Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: STAR-MAP health coaching, Medication reminder tools.
- Who it may be relevant to
- Registry conditions: Hypertension, Medication Adherence, Behavior and Behavior Mechanisms. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Behavioral STAR-MAP health coaching
Interactive health coaching delivered in 11 sessions over one year; focusing on using adaptive change tactics to improve medication-taking behavior - Behavioral Medication reminder tools
Medication-taking reminder app and pillbox
Primary outcome measures
- Difference in proportion with PDC >=0.8 at 12 months [Time frame: 12 months]
Secondary outcome measures (8)
- Difference in mean change in PDC, baseline to 12 months [Time frame: Baseline to 12 months]
- Difference in mean change in 4-item Krousel-Wood Medication Adherence Scale score, baseline to 12 months [Time frame: Baseline to 12 months]
- Difference in proportion with 4-item Krousel-Wood Medication Adherence Scale score <1 at 12 months [Time frame: 12 months]
- Difference in change in proportion with high adherence as measured by urine metabolite analysis, baseline to 12 months [Time frame: Baseline to 12 months]
- Difference in proportion with controlled BP at 12 months [Time frame: 12 months]
- Difference in mean change in SBP, baseline to 12 months [Time frame: Baseline to 12 months]
- Difference in mean change in DBP, baseline to 12 months [Time frame: Baseline to 12 months]
- Difference in mean change in health-related quality of life scores, baseline to 12 months [Time frame: Baseline to 12 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 5 centers
- Pennington Biomedical Research Center — Baton Rouge
- Tulane Doctors Dermatology & Multispecialty Clinic — Covington
- Tulane Doctors Heart & Vascular and Primary Care Clinic — Metairie
- Tulane University Clinical and Translational Unit — New Orleans
- LSU Health Sciences Shreveport Clinical Trials Office — Shreveport
Publications
- Peacock E, Mohundro B, Li J, Bazzano L, Shankar A, Petty R, Kegan R, Krousel-Wood M. Supporting tailored adaptive change and reinforcement for medication adherence program (STAR-MAP): Rationale and design of a randomized controlled clinical trial. Contemp Clin Trials. 2026 Jul;166:108353. doi: 10.1016/j.cct.2026.108353. Epub 2026 May 22. PMID 42173438
Identifiers
NCT: NCT05183763 · 2020-2221 · R01HL153750