Medication Adherence Program

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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
• Поведенческое Medication reminder tools
  Medication-taking reminder app and pillbox

Первичные конечные точки

• Difference in proportion with PDC >=0.8 at 12 months [Срок оценки: 12 months]

Вторичные конечные точки (8)

• Difference in mean change in PDC, baseline to 12 months [Срок оценки: Baseline to 12 months]
• Difference in mean change in 4-item Krousel-Wood Medication Adherence Scale score, baseline to 12 months [Срок оценки: Baseline to 12 months]
• Difference in proportion with 4-item Krousel-Wood Medication Adherence Scale score <1 at 12 months [Срок оценки: 12 months]
• Difference in change in proportion with high adherence as measured by urine metabolite analysis, baseline to 12 months [Срок оценки: Baseline to 12 months]
• Difference in proportion with controlled BP at 12 months [Срок оценки: 12 months]
• Difference in mean change in SBP, baseline to 12 months [Срок оценки: Baseline to 12 months]
• Difference in mean change in DBP, baseline to 12 months [Срок оценки: Baseline to 12 months]
• Difference in mean change in health-related quality of life scores, baseline to 12 months [Срок оценки: Baseline to 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

США · 5 центров

• 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

Публикации

• 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

Идентификаторы

NCT: NCT05183763 · 2020-2221 · R01HL153750

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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