跳至主要内容
临床试验/NCT02365051
NCT02365051已完成不适用

Translation of COPE for Publicly-Funded Home Care Clients and Their Families

UConn Health2 个研究点 分布在 1 个国家目标入组 582 人开始时间: 2015年5月1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
582
试验地点
2
主要终点
Functional dependence

研究概览

简要总结

This community-based translational trial tests the value of a proven non-pharmacologic intervention for older adults living with dementia and informal caregivers when this intervention is incorporated into a publicly-funded home and community based service program. Half the participants will receive customary publicly-funded services alone, and half will receive customary services plus the proven non-pharmacologic intervention.

详细描述

More than 5 million Americans have dementia and more than 15 million Americans, mostly family members, provide unpaid care to these individuals. In the absence of a cure or widely effective pharmacotherapy to combat dementia, translation and implementation of efficacious non-pharmacologic interventions into existing service programs are sorely needed. The Connecticut Home Care Program for Elders (CHCPE), a Medicaid waiver and state revenue-funded program for older adults at high risk for nursing home admission, provides in-home and community-based services coordinated by care managers. In this translational study, an evidence-based intervention, Care of Persons with Dementia in their Environments (COPE), is incorporated into the CHCPE. COPE is an efficacious 4-month, in-home, non-pharmacologic intervention using occupational therapists and advanced practice nurses to maximize physical function in older adults with dementia and to improve dementia management skills of family caregivers (CG).

This trial will randomly assign 290 CHCPE clients with dementia and their CGs to receive either COPE plus customary CHCPE services, or customary CHCPE services alone. The main study outcome measures are similar to those of the original COPE efficacy trial. To maximize the translational effort, this study also will: conduct a formal cost-benefit analysis to determine the potential economic benefit of adding COPE to customary CHCPE services; evaluate the feasibility and acceptability of COPE as a new CHCPE service; and establish an expert Translational Advisory Committee to help develop and guide COPE dissemination plans for implementation nationally.

Study aims for CHCPE clients:

Aim 1.1: Determine COPE effect on functional dependence 4 months after randomization (primary study endpoint).

Aim 1.2: Determine COPE effects on engagement in activities, quality of life, and NPS, 4 months after randomization.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Active client in publicly-funded home care program; Diagnosis of Alzheimer's disease or other dementia OR >=4 errors on the Mental Status Questionnaire; speaks or understands English

排除标准

  • Diagnosed schizophrenia or bipolar disorder; bedbound; participation in experimental drug study to treat agitation; home environment deemed unsafe or unsanitary.

结局指标

主要结局

Functional dependence

时间窗: Change in functional dependence score between baseline (pre-randomization) and 4 months post-randomization

The metric for the primary outcome measure is score on the 15-item Caregiver Assessment of Function and Upset (CAFU) measure. The CAFU is adapted from the Functional Independence Measure; each of the 15 items is an activity of daily living (ADL) or instrumental activity of daily living (IADL). Each ADL and IADL item is scored on a 7-point scale ranging from completely independent (score of 7) to needing complete help (score of 1). Person-level functional dependence scores are calculated by summing scores across all items and dividing by the number of items.

次要结局

未报告次要终点

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 (2)

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