Exploring the Role of Mindfulness Training in the Promotion of Medication Adherence in Heart Failure Outpatients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Retention Rate
研究概览
简要总结
This study investigated the feasibility and acceptability of a phone-delivered mindfulness intervention to improve medication adherence among outpatients with heart failure.
详细描述
This project seeked to study the role of mindfulness training (MT) in the promotion of medication adherence among patients with chronic heart failure (HF). A prospective pre/post design study was conducted among 50 stable outpatients with HF and sub-optimal self-reported medication adherence. MT sessions (one 30-min session/week over 8 weeks) were phone-delivered by qualified mindfulness instructors. Assessments were conducted at baseline, 3 months (end of the intervention) and 6 months since baseline. The primary outcomes were feasibility and acceptability. We hypothesized we would meet recruitment goals (n=50) within the study timeline, with < 20% drop out rates by the end of the study and that > 80% of participants would report high (=grade 5) enjoyment ratings on a self-report intervention enjoyment scale (range:1 to 5). Secondary outcomes were self-reported and objectively assessed medication adherence and functional capacity (a clinical marker of medication adherence. We hypothesized we would observe significant pre-post intervention improvements in medication adherence and functional capacity. Additional outcomes included possible mediators of intervention effect, i.e., cognitive function, mood, sleep quality, and interoceptive awareness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > = 18
- •Fluency in English language
- •A confirmed diagnosis of heart failure
- •Sub-optimal adherence to medications
- •Access to a telephone
- •Ability to understand and speak English
排除标准
- •Unwillingness/inability to provide informed consent
- •New York Heart Association (NYHA) class IV heart failure or clinically unstable
- •Severe hearing impairment not allowing phone delivery
- •Severe depressive symptoms
- •Acute psychosis
- •Severe cognitive impairment
- •Recent hospitalization (< 6 weeks)
- •Current (at least once a month) mind/body practice
结局指标
主要结局
Retention Rate
时间窗: 3 months, 6 months
Percentage of participants retained in the study (n enrolled/n retained X 100)
Intervention Acceptability
时间窗: 3 months
Self-reported intervention enjoyment scale (1 = did not enjoy to 5 = enjoyed very much). Scores range from 1 to 5; higher scores mean a better outcome. The metric for this study was the percentage of participants indicating high intervention enjoyment (a score of 5).
次要结局
- Objectively-assessed Medication Adherence(baseline, 3 months, 6 months)
- Self-reported Medication Adherence(baseline, 3 months, 6 months)
- Functional Capacity(baseline, 3 months, 6 months)
研究者
Elena Salmoirago-Blotcher
Research Scientist
The Miriam Hospital
