Translation of COPE for Publicly-Funded Home Care Clients and Their Families (COPECT)
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ClinicalTrials.gov Identifier: NCT02365051 |
Recruitment Status :
Completed
First Posted : February 18, 2015
Last Update Posted : October 5, 2020
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Condition or disease | Intervention/treatment | Phase |
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Dementia Alzheimer's Disease | Behavioral: Care of Persons with Dementia in their Environments | Not Applicable |

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 |

Arm | Intervention/treatment |
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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.
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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.
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Behavioral: Care of Persons with Dementia in their Environments
In-home visits by occupational therapist and advanced practice nurse.
Other Name: COPE |
- 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.

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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.

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 ClinicalTrials.gov identifier (NCT number): NCT02365051
United States, Connecticut | |
UConn Center on Aging | |
Farmington, Connecticut, United States, 06030-5215 |
Principal Investigator: | Richard H Fortinsky, PhD | UConn Health |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Fortinsky, Richard, Professor, UConn Health |
ClinicalTrials.gov 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. |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |