跳至主要内容
临床试验/NCT03571581
NCT03571581已完成不适用

Exploring the Role of Mindfulness Training in the Promotion of Medication Adherence in Heart Failure Outpatients.

The Miriam Hospital2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2018年10月11日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elena Salmoirago-Blotcher

Research Scientist

The Miriam Hospital

研究点 (2)

Loading locations...

相似试验

Mind Your Heart Study | 临床试验