Project COPE:Managing Dementia at Home

This study has been completed.
Sponsor:
Collaborator:
Pennsylvania Department of Health
Information provided by:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00259454
First received: November 28, 2005
Last updated: March 15, 2010
Last verified: March 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Managing Problem Behaviors of Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • ADL/IADL [ Time Frame: Baseline, t2, t3 ] [ Designated as safety issue: No ]
  • Caregiver upset [ Time Frame: Baseline, t2, t3 ] [ Designated as safety issue: No ]
  • Caregiver confidence [ Time Frame: when needed ] [ Designated as safety issue: No ]
  • Behaviors [ Time Frame: Baseline, t2, t3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 278
Study Start Date: June 2005
Study Completion Date: July 2009
Primary Completion Date: April 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
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, see Learn About Clinical Studies.

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 by Thomas Jefferson University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Laura N. Gitlin, Ph.D, Thomas Jefferson Univeristy-Center for Applied Research on Aging and Health
ClinicalTrials.gov Identifier: NCT00259454     History of Changes
Other Study ID Numbers: SAP 4100027298
Study First Received: November 28, 2005
Last Updated: March 15, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 31, 2014