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Project COPE:Managing Dementia at Home
This study is ongoing, but not recruiting participants.
First Received: November 28, 2005   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Thomas Jefferson University
Pennsylvania Department of Health
Information provided by: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00259454
  Purpose

This study tests the effectiveness of an in-home intervention to reduce upset and burden among family caregivers, and decrease nursing home placement.

The main hypothesis that will be tested is that compared to control group, subjects, experimental group participants will have enhanced well-being and fewer nursing home placements.


Condition Intervention Phase
Dementia, Alzheimer Type
Behavioral: In-home intervention
Phase III

Genetics Home Reference related topics: Alzheimer disease
MedlinePlus related topics: Alzheimer's Caregivers Alzheimer's Disease Caregivers Dementia Nursing Homes
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Active Control, Single Group Assignment
Official Title: Managing Problem Behaviors of Alzheimer's Disease

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Caregiver upset [ Time Frame: Baseline, t2, t3 ] [ Designated as safety issue: No ]
  • Burden [ Time Frame: Baseline, t2, t3 ] [ Designated as safety issue: No ]
  • Nursing home placement [ Time Frame: when needed ] [ Designated as safety issue: No ]
  • Care recipient behaviors [ Time Frame: Baseline, t2, t3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Caregiver mastery [ Time Frame: Baseline, t2, t3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 278
Study Start Date: June 2005
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: In-home intervention
    occupational therapy techniques to reduce caregiver stress
Detailed Description:

Implement a multi-component in-home intervention designed to prevent and ameliorate the troublesome behaviors that families typically confront and that often trigger nursing home placement. The intervention combines the most effective strategies that have been identified in previous caregiver research by the investigative team and best clinical practices to provide a comprehensive service approach to families and individuals with dementia including education, skills training, home safety, and stress management. To enhance its applicability to real-world practice within the aging service network, the intervention is designed to be reproducible and its components and treatment goals commensurate with the Medicaid Waiver Program. In the absence of evidence-based service protocols currently in place for this Waiver population, the intervention, if effective, would provide a systematic, evidence-based approach in the Medicaid Waiver program to help families and persons with dementia remain at home and in their communities.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Care-recipients must have a MMSE score < 24 and a diagnosis of dementia, live in the community, and either need help with one or more daily activities and/or have one or more behavioral occurrences. Caregivers must be a relative, at least 21 years of age, be English speaking, have a telephone, either live with the care-recipient (CR) or spend at least 48 hours per week in direct oversight or caring for him/her; plan to live in the area for 9 months, report upset with CR function dependence or behavioral occurrences.

Exclusion Criteria:

  • The CG-CR dyad will be excluded if CR has had more than 3 hospitalizations within the past 12 months, are in treatment for life-threatening cancer, have schizophrenia or a bipolar disorder, have dementia secondary to head trauma, have a MMSE score = 0 and are bed-bound (defined as confinement to bed or chair for at least 22 hours a day for at least four of the previous seven days); or they are enrolled in a clinical trial of pharmacological treatment for agitation. Also, the dyad will be excluded if the CG had more than 3 hospitalizations within the past 12 months or is in treatment for life-threatening cancer; is involved in another clinical trial of psychosocial or educational interventions for caregivers; or plans to place their family member in a nursing home within the next 9-months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00259454

Locations
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Pennsylvania Department of Health
Investigators
Principal Investigator: Laura N Gitlin, Ph.D Thomas Jefferson University
  More Information

Additional Information:
No publications provided

Responsible Party: Thomas Jefferson Univeristy-Center for Applied Research on Aging and Health ( Laura N. Gitlin, Ph.D )
Study ID Numbers: SAP 4100027298
Study First Received: November 28, 2005
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00259454     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
Caregivers
in-home care occupational therapy

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on May 07, 2009