Pilot Program to Improve Statin Adherence and Lower Cholesterol in Older Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Medication adherence
研究概览
简要总结
The purpose of this study is to pilot test a behavioral medication adherence (MA) intervention compared to control condition in older adults with low adherence to medication for hypercholesterolemia.
详细描述
This study will answer the following primary research question:
- What is the estimated effect size of a behavioral MA intervention on MA rates in older adults who are poorly adherent to statin medications?
The study will also explore the following secondary research questions: 2. What is the estimated effect size of a behavioral MA intervention on low-density lipoprotein cholesterol (LDL-C) levels in older adults? 3. What is the estimated effect size of a behavioral MA intervention on high-density lipoprotein cholesterol (HDL-C) levels in older adults? 4. What is the feasibility of successfully testing this intervention protocol in a population of older adults with low adherence to statin medications?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 60 or older at the time of study entry,
- •Take a once-daily prescription statin medication for ≥ 6 months with no changes to statin prescription for at least 30 days prior to study entry,
- •A score of ≤ 9 on the Short Blessed Test,
- •Participants must self-administer his or her own medications without prompts from any other person or device.
- •Baseline medication adherence rate of ≤ 90%.
- •Participants agree to complete all study contacts and measurements, including the use of a special medication bottle with a Medication Event Monitoring System (MEMS) cap for the duration of the study.
- •Able to open and close MEMS caps.
排除标准
- •Participant's medications are managed by someone other than the participant
- •Participant is unable or unwilling to use MEMS caps.
结局指标
主要结局
Medication adherence
时间窗: 6 months
次要结局
- Serum cholesterol(6 months)