跳至主要内容
临床试验/NCT03116464
NCT03116464终止不适用

Family Telemental Health Intervention for Veterans With Dementia

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2017年9月18日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
1
主要终点
Healthy Aging Brain Center Monitor (HABC Monitor):

研究概览

简要总结

Dementia impacts Veterans, their families, and other Veterans who serve as caregivers. One of the most stressful aspects of caregiving is the management of behavioral problems (e.g. wandering, agitation, and sleep difficulties), which exacerbate health issues for both caregivers and persons with dementia (PWD). Existing VA caregiver treatments for caregiver stress and behavioral problems are often ineffective. Many caregivers do not realize their interactions with PWD contribute to behavioral problems and thus do not ask for help to improve their interpersonal skills. The aim of this project is to develop an assessment of interpersonal skills deficits and a related treatment strategy to assist family caregivers of PWD who are challenged by a lack of interpersonal skills and are not helped by existing family caregiver treatments. This project, will develop and test (1) a video assessment of caregiver/PWD interaction that clinicians will use to identify interpersonal difficulties and (2) a family therapy for the interpersonal difficulties clinicians identify in the assessment.

详细描述

Study temporarily suspended due to COVID risk associated with at risk population of Veterans with Dementia and often older caregivers.

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

  • Either the caregiver or the care-recipient must be a Veteran.
  • The caregiver must:
  • Be the primary unpaid family or friend who helps or supports an individual with dementia
  • Be involved in the care of the person with dementia (at least 4 hours of care per day)
  • Report that the care-recipient exhibits behavioral problems that are distressing
  • Not be currently receiving the REACH VA protocol
  • Additionally, the care-recipient must:
  • Must have a documented diagnosis of dementia
  • Have cognitive impairment (MMSE<23 or SLUMS<20 or diagnosis of dementia based on chart review)
  • Be out of bed and able to respond to a caregiver's instructions or interventions

排除标准

  • Caregiver severe cognitive impairment
  • Caregiver inability to meet study demands
  • Caregiver psychosis

结局指标

主要结局

Healthy Aging Brain Center Monitor (HABC Monitor):

时间窗: Post Treatment, an average of 12-18 weeks

A 31-item caregiver assessment of dementia severity, caregiver stress, and mood. Contains three patient symptom domains (Cognitive, functional, behavioral/psychological) and a caregiver quality of life domain. Shown to have good internal consistency (0.73-0.92) and construct validity.

次要结局

  • Zarit Burden Scale(Post Treatment, an average of 12-18 weeks)
  • Patient Health Questionnaire - 9 (PHQ)(Post Treatment, an average of 12-18 weeks)
  • The Kansas Marital Conflict Scale (KMCS)(Post Treatment, an average of 12-18 weeks)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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