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临床试验/NCT05304117
NCT05304117已完成不适用

Culturally Tailoring an Advance Care Planning Intervention for American Indians

Western Carolina University2 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2022年2月4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
155
试验地点
2
主要终点
Count of Self-Report of Advance Directive

研究概览

简要总结

This project has three specific aims: (1) culturally tailor the content of the Make Your Wishes about You (MY WAY) ACP curriculum and guide for one American Indian tribe; (2) assess the feasibility of the culturally-tailored MY WAY ACP curriculum and patient education guide with the tribe; and (3) examine preliminary outcomes of the culturally-tailored MY WAY ACP curriculum and guide with 70 tribal members. Upon successful completion, it is expected that this project will develop a feasible culturally-tailored MY WAY that through a quasi-experimental waitlist design shows promise as an efficacious program with respect to self-efficacy, readiness, and ACP completion that increases facilitators and decreases barriers to ACP.

详细描述

Research Design. A quasi-experimental waitlist study design will be used to test the hypothesis that the intervention participants will experience increased ACP self-efficacy, readiness, and completion rates. It is also expected that the intervention participants will experience increased facilitators and decreased barriers to ACP. A control sample of waitlist participants will be used.

Based on the odds of completing an ACP indicated in previously implemented MY WAY interventions and using 90% power as a threshold, it is estimated that will be a need for at least an n = 60 to find effects. The intervention group, Cohort 1, will be those who participated in the first round of both the Community Educational Sessions and Sharing Sessions. The control group, Cohort 2, will be those who participated in the second round of both the Community Education Sessions and Sharing Sessions.

Measurement. Process Measures that are a part of the 9-item ACP Engagement Survey that includes measurement of self-efficacy and readiness, identified from Behavioral Change Theory, will be used. Self-efficacy and readiness subscales have Likert responses of "not at all, a little, somewhat, fairly, extremely" and have good reliability and discriminant validity. Barriers and Facilitators to ACP Questionnaire used in the MY WAY randomized controlled trial will be used. Pretest interviews with these measurements will be conducted by telephone or in person at the time of pre-registration for both cohorts by the Project Coordinator and team members.

Cohort 1 will be interviewed five times: Baseline pretest, Community Information Session Evaluation; Sharing Session Evaluation, 8 week-post test and 6 month post-test.

Cohort 2 will be interviewed five times: Baseline pretest, 2nd baseline control pretest, waitlist Community Information Session evaluation, and waitlist Sharing Session evaluation, 8 week post test.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
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

  • aged ≥18 years
  • either enrolled member or spouse of enrolled member in tribal service area
  • Member of another American Indian/Alaskan Native tribe
  • English fluency
  • Resides in the tribal service area.

排除标准

  • Cognitively impaired

结局指标

主要结局

Count of Self-Report of Advance Directive

时间窗: Cohort 1 Experimental: Baseline and Post-test (week 8); Cohort 2 Waitlist: Baseline 1 and Baseline 2 (3-6 months after baseline and immediately before intervention); Cohort 2 Experimental; Baseline 1 and post-test (5-8 months after 1st baseline)

The proportion of participants who self-report advance directive completion.

Average Advance Care Planning -Engagement Readiness

时间窗: Cohort 1 Experimental: Baseline and Post-test (week 8); Cohort 2 Waitlist: Baseline 1 and Baseline 2 (3-6 months after baseline and immediately before intervention); Cohort 2 Experimental; Baseline 1 and post-test (5-8 months after 1st baseline)

The mean ACP Readiness scores range from 1-6, with higher scores indicating greater readiness.

Average Advance Care Planning-Engagement Self-Efficacy

时间窗: Cohort 1 Experimental: Baseline and Post-test (week 8); Cohort 2 Waitlist: Baseline 1 and Baseline 2 (3-6 months after baseline and immediately before intervention); Cohort 2 Experimental; Baseline 1 and post-test (5-8 months after 1st baseline)

The mean ACP Self-Efficacy scores range from 1-6, with higher scores indicating greater self-efficacy. not at all, a little, somewhat, fairly, extremely Higher scores indicate better outcomes.

次要结局

  • Average Number of Barriers to Advance Care Planning(Cohort 1 Experimental: Baseline and Post-test (week 8); Cohort 2 Waitlist: Baseline 1 and Baseline 2 (3-6 months after baseline and immediately before intervention); Cohort 2 Experimental; Baseline 1 and post-test (5-8 months after 1st baseline))
  • Average Number of Facilitators for Advance Care Planning(Cohort 1 Experimental: Baseline and Post-test (week 8); Cohort 2 Waitlist: Baseline 1 and Baseline 2 (3-6 months after baseline and immediately before intervention); Cohort 2 Experimental; Baseline 1 and post-test (5-8 months after 1st baseline))

研究者

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

Elizabeth Anderson

Assistant Professor of Social Work

Western Carolina University

研究点 (2)

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