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CompletedNCT00259454Updated Mar 16, 2010

Project COPE:Managing Dementia at Home

A Phase 3 interventional study of In-home intervention in Dementia, Alzheimer Type, sponsored by Thomas Jefferson University. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-03-16.

Sponsored by Thomas Jefferson University · Phase 3 and Interventional

Phase
Phase 3
Study type
Interventional
Enrollment
278
Allocation
Randomized
Ages
21 Years and older
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Dementia, Alzheimer Type

Keywords

  • Caregivers
  • in-home care occupational therapy
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In context

Dementia

2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.

This study's planned enrollment of 278 is above the median of 83 across 1,629 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.

Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Phase 3
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
278 participants (estimated)

Interventions

  • BehavioralIn-home intervention

    occupational therapy techniques to reduce caregiver stress

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What researchers measure

Primary outcomes

  1. ADL/IADL

    Time frame: Baseline, t2, t3

  2. Caregiver upset

    Time frame: Baseline, t2, t3

  3. Caregiver confidence

    Time frame: when needed

  4. Behaviors

    Time frame: Baseline, t2, t3

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Study locations

1 site
  • Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
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References and documents

Publications

  • Hodgson NA, Gitlin LN, Winter L, Czekanski K. Undiagnosed illness and neuropsychiatric behaviors in community residing older adults with dementia. Alzheimer Dis Assoc Disord. 2011 Apr-Jun;25(2):109-15. doi: 10.1097/WAD.0b013e3181f8520a. PubMed 20921879 ↗
  • Gitlin LN, Winter L, Dennis MP, Hodgson N, Hauck WW. A biobehavioral home-based intervention and the well-being of patients with dementia and their caregivers: the COPE randomized trial. JAMA. 2010 Sep 1;304(9):983-91. doi: 10.1001/jama.2010.1253. PubMed 20810376 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00259454
Lead sponsor
Thomas Jefferson University
Collaborators
Pennsylvania Department of Health
First posted
Nov 29, 2005
Start date
Jun 2005
Primary completion
Apr 2009
Completion
Jul 2009
Last update
Mar 16, 2010

Study contacts

Laura N Gitlin, Ph.D
principal investigator · Thomas Jefferson University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

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