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临床试验/NCT05080777
NCT05080777已完成不适用

Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems

UConn Health4 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2021年9月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
74
试验地点
4
主要终点
Change in Caregiver Mastery

研究概览

简要总结

This cluster randomized pragmatic clinical trial will test the effectiveness and feasibility of embedding the Tele-Savvy intervention, a psychoeducational program for family and other informal caregivers of older adults living in the community with Alzheimer's disease and related dementia (ADRD), in two health care systems/clinical sites: UConn Health in Farmington, Connecticut, and Emory Healthcare in Atlanta, Georgia.

详细描述

This cluster randomized pragmatic clinical trial will test the effectiveness and feasibility of embedding the Tele-Savvy intervention, a psychoeducational program for family and other informal caregivers of older adults living in the community with Alzheimer's disease and related dementia (ADRD), in two health care systems/clinical sites: UConn Health in Farmington, Connecticut, and Emory Healthcare in Atlanta, Georgia. A total of 100 caregivers, 50 at each study site, will participate in this pilot study. At each site, 30 caregivers will be randomly assigned to receive the Tele-Savvy intervention, and 20 caregivers will be randomly assigned to receive the self-guided Caregiving During Crisis online program.

All 100 caregivers will complete identical self-administered questionnaires to measure the caregiver-specific outcome measures in this pilot study. Outcome measures will include caregiver mastery (primary outcome), caregiver response to specific memory and behavioral problems, and caregiver stress. Also, we will employ process measures of participation and engagement in the interventions for caregivers in both arms of the trial, as well as implementation outcomes via surveys with clinicians and Information Technology staff at each of the two clinical sites responsible for programming electronic medical records to enable capture and storage of caregiver outcomes.

研究设计

研究类型
Interventional
分配方式
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 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Identified by EHR systems and confirmed by a health care provider as a family member or unpaid significant other who provides care at home for an older adult (age 65 or older) living with ADRD
  • English speaking
  • Able to understand study procedures and comply with them for the entire length of the study
  • Access to appropriate video and audio technology to be able to participate in interventions

排除标准

  • Unwilling to be randomized to receive either Tele-Savvy or Caregiving During Crisis
  • Planning to admit the person living with ADRD to a nursing home on a long-term basis within 6 months of randomization.

结局指标

主要结局

Change in Caregiver Mastery

时间窗: pre-randomization; 3 months post-randomization; and 6 months post-randomization (6 months post-randomization for Emory site only)

Caregiving competence scale, minimum and maximum values 4-16, higher scores mean greater mastery.

次要结局

  • Change in Caregiver Reactions(pre-randomization; 3 months post-randomization; and 6 months post-randomization (6 months post-randomization for Emory site only))
  • Change in Caregiver Stress(pre-randomization; 3 months post-randomization; and 6 months post-randomization (6-month post randomization for Emory site only))

研究者

发起方
UConn Health
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fortinsky, Richard

Professor

UConn Health

研究点 (4)

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