PACT: Providers and Alzheimer's Caregivers Together
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|ClinicalTrials.gov Identifier: NCT00182897|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : November 14, 2006
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease Dementia||Behavioral: Skills Building for Caregiver Health and Care-recipient||Not Applicable|
This study focuses on an underserved, understudied population: African American and White homebound persons with dementia and their caregivers (CGs). Severe dementia, frailty, multiple disabling co-morbid diseases, lack of transportation, inability to afford or obtain a sitter for the care recipient (CR), and lack of time in a CG's burdened daily schedule may prevent care dyads (caregivers and their family member with dementia) from receiving services in primary care settings and from participating in clinical studies. Homebound issues may be particularly important for African American CGs, yet the minority CG literature has not addressed relevant issues for homebound dyads. Nor are the chronic needs of homebound dementia care dyads adequately attended by the current home health care system, which now focuses on skilled nursing care. This study has been designed to address these research deficits. The study will examine the benefit (through improving depression, anxiety, and health perception) and the cost-effectiveness of home-based dementia caregiving interventions, with attention to both the informal care provided by the CG and the use of formal care services.
Care dyads will be randomized to either Usual Care or Enhanced Care. Both Usual Care and Enhanced Care caregivers will receive usual home health care delivered by home health nurses on the schedule determined by the patient's needs and set by the home care agency. For the Enhanced Care caregivers, to ensure protocol adherence, using the same schedule as the home health visits, trained interventionists from the research staff will deliver the intervention. The interventionists will teach dementia family caregivers to cope with difficult care recipient behaviors and challenges to caregiving and will teach caregivers how to cope with their own responses to caregiving. Following established protocols and using fifth grade level pamphlets and educational material, the interventionists will tailor the intervention sessions to meet the individual needs of each care dyad in their own home environment. Enhanced Care sessions will not exceed 60 minutes. Research specialists will perform data collection visits in the care dyads’ homes at baseline, within 2 weeks of home care ending and six months.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Providers and Alzheimer's Caregivers Together|
|Study Start Date :||October 2000|
|Study Completion Date :||November 2005|
- General well-being, measured with the revised Rand General Well-Being Scale
- caregiver’s level of distress with care recipient behaviors, measured with the Revised Memory and Behavior Problems Checklist at Baseline, within 2 weeks of home care ending and six months.
- Determine the cost-effectiveness of home-based intervention; data will be collected at Baseline, within 2 weeks of home care ending and six months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00182897
|United States, Tennessee|
|University of Tennessee Health Science Center|
|Memphis, Tennessee, United States, 38163|
|Principal Investigator:||Linda Nichols, PhD||Program Director, Interprofessional Team Training & Development, Veterans Affairs Medical Center; Associate Professor, Preventive Medicine and Medicine, University of Tennessee Health Science Center|