Impact of SystemCHANGE™ Intervention on Medication Adherence in Older Adults With Heart Failure: A Pilot RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Acceptability and feasibility using open ended questionnaire
研究概览
简要总结
The purpose of this pilot RCT study is to evaluate the acceptability and feasibility of a SystemCHANGE™ intervention to improve medication adherence in older adults with heart failure. The intervention focuses on changing the individual's environment by incorporating medication taking into existing routines using small experiments with feedback, and receiving support from people who impact routines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 50 years or older
- •HF diagnosis confirmed by their physician utilizing their most recent ejection fraction
- •prescribed diuretics
- •self-administering medications
- •able to open an electronic cap
- •able to speak, hear and understand English
- •not hospitalized,
- •no cognitive impairment as determined by a score of 4 or greater on the 6-item mini-mental status exam.
排除标准
- 未提供
研究组 & 干预措施
SystemCHANGE intervention
The SystemCHANGE™ intervention utilizes the Socioecological Model and Plan-Do-Check Act model as its framework and focuses on changing the individual's environment to change behavior using small experiments with feedback.
干预措施: SystemCHANGE (Behavioral)
Attention Control
The attention control group will receive education at baseline, 1 month, and 2 months following America Heart Association brochures.
结局指标
主要结局
Acceptability and feasibility using open ended questionnaire
时间窗: one point in time at the end of the maintenance phase which is 3 months after randomization into groups
open ended questionnaire asking participants about acceptability and feasibility
次要结局
- Systems thinking using questionnaire(baseline and after 2 month intervention phase)
- Kansas City Cardiomyopathy Questionnaire(baseline and after 2 month intervention phase)
- Medication adherence using medication event monitoring systems(after randomization through end of maintenance phase for a total of 3 months)
研究者
Angela Andrews
PhD Student
University of Missouri, Kansas City