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临床试验/NCT05310877
NCT05310877已完成不适用

Feasibility and Acceptability of a Values-Affirmation Intervention Targeting Medication Adherence in Older Adults With Heart Failure

The Miriam Hospital1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2022年2月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
1
主要终点
Feasibility of Intervention Procedures

研究概览

简要总结

Heart failure (HF) represents a significant public health concern. Medication non-adherence represents 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. Similar interventions have promoted weight loss, increased adherence and physical activity, and more frequent fruit and vegetable consumption in a variety of contexts and populations. This study seeks to test a recently developed values-affirmation intervention targeting medication adherence in older adults with HF enrolled in cardiac rehabilitation (CR). The purpose of this feasibility study is to test methodology to aid development of a subsequent randomized controlled pilot trial to examine preliminary efficacy.

详细描述

The objective of this study is to examine the preliminary feasibility and acceptability of study procedures and the values-affirmation intervention in a single-arm trial. Participants will be asked to complete a brief intervention with tailored education relevant to medication information, motivation, and behavioral skills. Participants will complete a baseline assessment and a follow-up assessment at one month post-intervention. The investigators hypothesize that the developed study and intervention procedures will be feasible and acceptable to participants. The investigators will also examine changes in self-reported and electronically monitored medication adherence from the baseline assessment to follow-up.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
55 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
  • •At risk for medication non-adherence based on self-report screening or number of prescribed medications

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
  • •Terminal illness with an expected lifespan of less than 6 months

研究组 & 干预措施

Values-affirmation

Experimental

干预措施: Values-Affirmation (Behavioral)

结局指标

主要结局

Feasibility of Intervention Procedures

时间窗: Week 4

Proportion of enrolled participants who complete the study

Feasibility of Recruitment Procedures

时间窗: Baseline

Proportion of eligible participants who enroll in the study

Acceptability Assessed Via Qualitative Exit Interview- Number of Participants Who Completed Interview

时间窗: Week 4

Qualitative exit interview to assess patient reported satisfaction with intervention content, intervention delivery, and study procedures

次要结局

  • Self-reported Medication Adherence(Baseline, 4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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