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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 402
- 试验地点
- 10
- 主要终点
- Difference in proportion with PDC >=0.8 at 12 months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
The Data Manager will calculate the primary outcome measure from pharmacy refill data prior to merging with any data file indicating group assignment. Laboratory technicians who perform the liquid chromatography tandem mass spectrometry analysis of urine metabolites of antihypertensive medications will also be blinded to group assignment. Finally, participants' primary care providers will be notified of their patients' enrollment into the study but will not be given information about group assignment.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
STAR-MAP
Interactive health coaching sessions and medication reminder tools
干预措施: Medication reminder tools (Behavioral)
STAR-MAP
Interactive health coaching sessions and medication reminder tools
干预措施: STAR-MAP health coaching (Behavioral)
Medication App and Reminder System Medication Adherence Program (MARS-MAP)
Medication reminder tools only
干预措施: Medication reminder tools (Behavioral)
结局指标
主要结局
Difference in proportion with PDC >=0.8 at 12 months
时间窗: 12 months
Proportion of days covered (PDC) calculated from pharmacy refill data
次要结局
- Difference in proportion with controlled BP at 12 months(12 months)
- Difference in proportion with 4-item Krousel-Wood Medication Adherence Scale score <1 at 12 months(12 months)
- Difference in mean change in SBP, baseline to 12 months(Baseline to 12 months)
- Difference in mean change in PDC, baseline to 12 months(Baseline to 12 months)
- Difference in mean change in 4-item Krousel-Wood Medication Adherence Scale score, baseline to 12 months(Baseline to 12 months)
- Difference in change in proportion with high adherence as measured by urine metabolite analysis, baseline to 12 months(Baseline to 12 months)
- Difference in mean change in DBP, baseline to 12 months(Baseline to 12 months)
- Difference in mean change in health-related quality of life scores, baseline to 12 months(Baseline to 12 months)