NCT02365051

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
582

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

June 6, 2023

Status Verified

June 1, 2023

Enrollment Period

3.8 years

First QC Date

January 26, 2015

Last Update Submit

June 3, 2023

Conditions

DementiaAlzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • Functional dependence

    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.

    Change in functional dependence score between baseline (pre-randomization) and 4 months post-randomization

Study Arms (2)

usual care

NO INTERVENTION

Older adults with dementia and their family caregivers receive all services for which they are eligible in the Connecticut Home Care Program for Elders.

COPE plus usual care

EXPERIMENTAL

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

Interventions

Care of Persons with Dementia in their EnvironmentsBEHAVIORAL

In-home visits by occupational therapist and advanced practice nurse.

Also known as: COPE
COPE plus usual care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UConn Center on Aging

Farmington, Connecticut, 06030-5215, United States

Location

Related Publications (4)

  • Fortinsky RH, Gitlin LN, Pizzi LT, Piersol CV, Grady J, Robison JT, Molony S. Translation of the Care of Persons with Dementia in their Environments (COPE) intervention in a publicly-funded home care context: Rationale and research design. Contemp Clin Trials. 2016 Jul;49:155-65. doi: 10.1016/j.cct.2016.07.006. Epub 2016 Jul 6.

    PMID: 27394383RESULT

  • Fortinsky RH, Gitlin LN, Pizzi LT, Piersol CV, Grady J, Robison JT, Molony S, Wakefield D. Effectiveness of the Care of Persons With Dementia in Their Environments Intervention When Embedded in a Publicly Funded Home- and Community-Based Service Program. Innov Aging. 2020 Oct 26;4(6):igaa053. doi: 10.1093/geroni/igaa053. eCollection 2020.

    PMID: 33367114RESULT

  • Pizzi LT, Jutkowitz E, Prioli KM, Lu EY, Babcock Z, McAbee-Sevick H, Wakefield DB, Robison J, Molony S, Piersol CV, Gitlin LN, Fortinsky RH. Cost-Benefit Analysis of the COPE Program for Persons Living With Dementia: Toward a Payment Model. Innov Aging. 2021 Oct 16;6(1):igab042. doi: 10.1093/geroni/igab042. eCollection 2022.

    PMID: 35047708RESULT

  • Kellett K, Robison J, McAbee-Sevick H, Gitlin LN, Verrier Piersol C, Fortinsky RH. Implementing the Care of Persons With Dementia in Their Environments (COPE) Intervention in Community-Based Programs: Acceptability and Perceived Benefit From Care Managers' and Interventionists' Perspectives. Gerontologist. 2023 Jan 24;63(1):28-39. doi: 10.1093/geront/gnac068.

    PMID: 35581164RESULT

MeSH Terms

Conditions

DementiaAlzheimer Disease

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative Diseases

Study Officials

  • Richard H Fortinsky, PhD

    UConn Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 26, 2015

First Posted

February 18, 2015

Study Start

May 1, 2015

Primary Completion

March 1, 2019

Study Completion

September 30, 2019

Last Updated

June 6, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

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.

Locations

US(1)