Project COPE:Managing Dementia at Home
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 28, 2005 | ||||
| Last Updated Date | March 15, 2010 | ||||
| Start Date ICMJE | June 2005 | ||||
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
|
||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00259454 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Project COPE:Managing Dementia at Home | ||||
| Official Title ICMJE | Managing Problem Behaviors of Alzheimer's Disease | ||||
| Brief 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. |
||||
| 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. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label |
||||
| Condition ICMJE | Dementia, Alzheimer Type | ||||
| Intervention ICMJE | Behavioral: In-home intervention
occupational therapy techniques to reduce caregiver stress |
||||
| Study Arm (s) | Not Provided | ||||
| Publications * |
|
||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 278 | ||||
| Completion Date | July 2009 | ||||
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00259454 | ||||
| Other Study ID Numbers ICMJE | SAP 4100027298 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Laura N. Gitlin, Ph.D, Thomas Jefferson Univeristy-Center for Applied Research on Aging and Health | ||||
| Study Sponsor ICMJE | Thomas Jefferson University | ||||
| Collaborators ICMJE | Pennsylvania Department of Health | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Thomas Jefferson University | ||||
| Verification Date | March 2010 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||