Pilot Randomized Controlled Trial of a Values-Affirmation Intervention Targeting Medication Adherence in Older Adults With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Acceptability of Intervention and Study Procedures
研究概览
简要总结
The goals of this study are to determine the (1) feasibility and (2) acceptability of the study procedures through a pilot randomized controlled trial of a values affirmation intervention targeting medication adherence in adults with heart failure enrolled in cardiac rehabilitation relative to usual care.
详细描述
Heart failure (HF) represents a significant public health concern. Medication non-adherence is a modifiable contributor to costly hospital readmissions in older adults with HF. Educational interventions improve, but do not eliminate, non-adherence. Values affirmation interventions which invite individuals to reflect on core values may encourage better engagement in health behaviors by increasing the personal relevance of targeted behaviors. This study tests a values-affirmation intervention targeting medication adherence in older adults with HF enrolled in cardiac rehabilitation.
The objective of this study is to examine the feasibility and acceptability of study procedures and the values-affirmation intervention in a pilot randomized controlled trial. Participants will complete a baseline assessment including 30 days of medication monitoring using electronic medication monitoring devices. After the baseline medication monitoring period, participants will be randomly assigned to either the intervention or control condition. Intervention participants will be asked to complete a brief intervention with tailored education relevant to medication information, motivation, and behavioral skills in additional to their usual cardiac rehabilitation care. Control participants will continue with their usual care. Participants will be asked to continue using the medication monitoring devices and to complete a final assessment 30 days later.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart failure
- •Enrolled in cardiac rehabilitation
- •Read and understand English
排除标准
- •Current participation in another medication-monitoring clinical or research protocol
- •New York Heart Association class IV heart failure
- •Diagnosis of Alzheimer's, dementia, or severe cognitive impairment indicated on screening
- •Current suicidality or psychosis
研究组 & 干预措施
Values Affirmation + Usual Care
干预措施: Values Affirmation + Usual Care (Behavioral)
Usual Care
干预措施: Usual Care (Other)
结局指标
主要结局
Acceptability of Intervention and Study Procedures
时间窗: Post-test (2-months)
Participant self-reported satisfaction with intervention content and delivery \[intervention group only\] and study procedures
Retention
时间窗: 2 months
Proportion of enrolled participants who completed the final assessment
次要结局
- Medication Adherence (Electronically Monitored)(1 month; calculated as the difference between Baseline and post-test)
- Change in Medication Adherence (Self-report)(Baseline, post-test (2-months))
- Medication Adherence (Pill Count)(Baseline, post-test (2-months))