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.
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
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.
Aim 1.3: Determine COPE effects on functional dependence, engagement in activities, quality
of life, and neuropsychiatric symptoms (NPS), 12 months after randomization.
We hypothesize that CHCPE clients receiving COPE will show greater reduction in functional
dependence, greater engagement in activities, better quality of life, and fewer
neuropsychiatric symptoms, compared to controls, 4 months and 12 months after randomization.
Study aims for CGs:
Aim 2.1: Determine COPE effect on perceived CG well-being 4 months after randomization.
Aim 2.2: Determine COPE effects on CG confidence in using dementia management strategies 4
months after randomization.
Aim 2.3: Determine COPE effects on CG perceived well-being, confidence in using activities,
and ability to keep client at home, 12 months after randomization.
We hypothesize that COPE CGs will report improvement in all specified outcomes compared to
controls, 4 and 12 months after randomization.
Translational study aims:
Aim 3.1: Determine the net financial benefit of COPE, accounting for COPE intervention
costs, CHCPE usual care costs, nursing home costs, and other service costs, 4 months and 12
months after randomization. The 12 month cost-benefit analysis will test whether financial
benefits of COPE accrue over a longer time horizon than the 4-month intervention period.
Aim 3.2: Determine the feasibility and acceptability of COPE implementation into the CHCPE
from multiple stakeholder viewpoints, including CHCPE care managers and state Medicaid and
public policy decision makers.
- 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
- Diagnosed schizophrenia or bipolar disorder; bedbound; participation in experimental
drug study to treat agitation; home environment deemed unsafe or unsanitary.