Trial record 1 of 1 for:    NCT00259454
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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

November 28, 2005
March 15, 2010
June 2005
April 2009   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00259454 on ClinicalTrials.gov Archive Site
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Project COPE:Managing Dementia at Home
Managing Problem Behaviors of Alzheimer's Disease

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Dementia, Alzheimer Type
Behavioral: In-home intervention
occupational therapy techniques to reduce caregiver stress
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
278
July 2009
April 2009   (final data collection date for primary outcome measure)

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.
Both
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00259454
SAP 4100027298
Yes
Laura N. Gitlin, Ph.D, Thomas Jefferson Univeristy-Center for Applied Research on Aging and Health
Thomas Jefferson University
Pennsylvania Department of Health
Principal Investigator: Laura N Gitlin, Ph.D Thomas Jefferson University
Thomas Jefferson University
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP