Ignite Creation Date:
2024-05-06 @ 3:45 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02365051
Status:
COMPLETED
Last Update Posted:
2023-06-06
First Post:
2015-01-26
Brief Title:
Translation of COPE for Publicly-Funded Home Care Clients and Their Families
Sponsor:
UConn Health
Organization:
UConn Health
Study Overview
Official Title:
Translation of COPE for Publicly-Funded Home Care Clients and Their Families
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPECT
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 11 Determine COPE effect on functional dependence 4 months after randomization primary study endpoint
Aim 12 Determine COPE effects on engagement in activities quality of life and NPS 4 months after randomization
Aim 13 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 21 Determine COPE effect on perceived CG well-being 4 months after randomization
Aim 22 Determine COPE effects on CG confidence in using dementia management strategies 4 months after randomization
Aim 23 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 31 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 32 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
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 11 Determine COPE effect on functional dependence 4 months after randomization primary study endpoint
Aim 12 Determine COPE effects on engagement in activities quality of life and NPS 4 months after randomization
Aim 13 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 21 Determine COPE effect on perceived CG well-being 4 months after randomization
Aim 22 Determine COPE effects on CG confidence in using dementia management strategies 4 months after randomization
Aim 23 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 31 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 32 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None