跳至主要内容
临床试验/NCT06177990
NCT06177990招募中不适用

Caregiver as Navigator: Develop Skills Online (CAN-DO) Developing Dementia Family Caregiver Mastery for Navigating Complex Health, Social Service, Legal, Financial, and Family Systems

Emory University1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2024年12月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
270
试验地点
1
主要终点
Change in Pearlin Caregiver Stress Scales score

研究概览

简要总结

This study is designed to learn more about ways to promote caregiver mastery online. 270 dementia family caregivers will be enrolled and randomized to take the CAN-DO online course immediately or after a waiting period. They will participate in interviews before and after the course; total time of study participation is 6 months.

详细描述

Family members and friends are the core of the uncoordinated system of care that tenuously maintains persons living with dementia in their community settings and delays their placement into more costly settings of institutional care, providing more contributed and out of pocket care support than Medicare and Medicaid combined.

The CAN-DO program fills a significant gap in caregiver psychoeducation programming by focusing not principally on day-to-day care management but on the many substantial system navigation tasks that caregivers assume. Supported by preliminary efficacy data, CAN-DO will employ state-of-the art asynchronous interactive learning methods to enhance caregivers' mastery of skills and confidence to navigate healthcare and other (legal, financial, social service, and family) systems that are crucial to the continued community living of persons affected with dementia illnesses.

This study will enroll 270 dementia family caregivers who will be randomized to take the CAN-DO course immediately or after a waiting period. They will participate in interviews before and after the course; total time of study participation is 6 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • Family member or friend providing at least 4 hours per week of informal care for a community-dwelling person living with ADRD
  • 18 years or older
  • Has internet access
  • Does not have to co-reside with the individual
  • Understands, speaks, and reads English

排除标准

  • Family caregiver plans to move care recipient to an institutional setting within the next six months
  • Care recipient currently enrolled in hospice

结局指标

主要结局

Change in Pearlin Caregiver Stress Scales score

时间窗: Baseline, 2, 4, 6, and 8 months post-intervention

This primary outcome will measure Caregiver Mastery (including Competence, Confidence, Management of Situation). The Pearlin caregiver scale includes 8 items, with a rating from 1-4 for each of them. Total possible score range is 8-32. Higher score correlates with better outcome.

Change in Caregiver Assessment of Behavioral Skill scale score

时间窗: Baseline, 2, 4, 6, and 8 months post-intervention

This study outcome will also measure Caregiver Mastery. Caregiver Assessment of Behavioral Skills score will be assessed using the Fortinsky scale that includes 17 items rated from 0-3 each. Possible score range is 0-51. Higher score correlates with better outcome.

Change in Perceived Stress Scale score

时间窗: Baseline, 2, 4, 6, and 8 months post-intervention

This outcome will measure Caregiver Emotional Wellbeing. The Perceived Stress Scale includes 10 items, each of them rated 1-5, with a total possible score 10-50. Lower score correlates with better study outcome.

Change in State-Trait Anxiety Scale score

时间窗: Baseline, 2, 4, 6, and 8 months post-intervention

This outcome will measure Caregiver Emotional Wellbeing. The State-Trait Anxiety Scale includes 20 items, each of them rated 1-4. Total possible score range 20-80 with higher score correlated with better study outcome.

Change in Caregiver Burden Index

时间窗: Baseline, 2, 4, 6, and 8 months post-intervention

This outcome will measure Caregiver Emotional Wellbeing. The caregiver burden Index includes 22 items, each of them rated 0-4, with a total possible score 0-88. Lower score correlates with better study outcome.

Change in Dyadic Relationship Scale score

时间窗: Baseline, 2, 4, 6, and 8 months post-intervention

This outcome will assess Caregiver Emotional Wellbeing. The Dyadic Relationship Scale includes 11 items rated from 1 to 4, with a total possible score range 11-44. Higher score correlates with better outcome.

次要结局

  • Change in Quality of Life in Alzheimer's score(Baseline, 2, 4, 6, and 8 months post-intervention)
  • Change in Revised Memory and Behavior Problem Checklist score(Baseline, 2, 4, 6, and 8 months post-intervention)

研究者

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

Carolyn Clevenger

Professor

Emory University

研究点 (1)

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