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Clinical Trials/NCT02365051
NCT02365051CompletedNot Applicable

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

UConn Health2 sites in 1 country582 target enrollmentStarted: May 1, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
582
Locations
2
Primary Endpoint
Functional dependence

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Functional dependence

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
UConn Health
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Fortinsky, Richard

Professor

UConn Health

Study Sites (2)

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