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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02365051
Recruitment Status : Completed
First Posted : February 18, 2015
Last Update Posted : October 5, 2020
Information provided by (Responsible Party):
Fortinsky, Richard, UConn Health

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.

Condition or disease Intervention/treatment Phase
Dementia Alzheimer's Disease Behavioral: Care of Persons with Dementia in their Environments Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 582 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Translation of COPE for Publicly-Funded Home Care Clients and Their Families
Actual Study Start Date : May 2015
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: usual care
Older adults with dementia and their family caregivers receive all services for which they are eligible in the Connecticut Home Care Program for Elders.
Experimental: COPE plus usual care
Older adults with dementia and their family caregivers receive Usual care plus the intervention: Care of Persons with Dementia in their Environments.
Behavioral: Care of Persons with Dementia in their Environments
In-home visits by occupational therapist and advanced practice nurse.
Other Name: COPE

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02365051

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United States, Connecticut
UConn Center on Aging
Farmington, Connecticut, United States, 06030-5215
Sponsors and Collaborators
UConn Health
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Principal Investigator: Richard H Fortinsky, PhD UConn Health
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Fortinsky, Richard, Professor, UConn Health Identifier: NCT02365051    
Other Study ID Numbers: 15-014-3
First Posted: February 18, 2015    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study results will be disseminated through peer-reviewed publications and presentations at national meetings in gerontology, geriatrics, public health, occupational therapy and nursing. Research-quality data which documents, supports and validates research findings will be made publicly available after main findings from the final research data set have been accepted for publication. Such data will be completely de-identified to prevent disclosure of individual study participant information, and will be shared on electronic media. We will request a data-sharing agreement that provides for a commitment to using the data only for research purposes, securing the data using appropriate computer technology, not redistributed to third parties, destroying or returning the data after analyses are completed, and a proper acknowledgement of the data resource.
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders