Status:
COMPLETED
Home Safety Clinical Trial for Alzheimer's Disease
Lead Sponsor:
US Department of Veterans Affairs
Collaborating Sponsors:
Boston Medical Center
Conditions:
Alzheimer's Disease
Dementia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study was to test the effectiveness of a new multimodal educational intervention to improve home safety for persons with dementia of the Alzheimer's type and their home caregivers.
Detailed Description
Objectives: The purpose of this research study was to test the effectiveness of a new multimodal educational intervention to improve caregiver competence to create a safer home environment, and decrea...
Eligibility Criteria
Inclusion
- Subjects are dyads of primary caregivers and persons with a progressive DAT who live in the community, are willing to have home visits for home safety education, and who read and speak English.
- Inclusion criteria for care recipients are: diagnosis of DAT, score of 24 or less on the Mini-Mental State Exam (MMSE), is expected to continue living in the community for the next 6 months, and has the ability to ambulate without help from the caregiver.
- Inclusion criteria for the primary informal caregiver are: lives in the home with the care-recipient, provides a minimum of 4 hours of care-giving or supervision per day, and has no known cognitive impairment as judged by the primary care provider who refers the subject dyad for study recruitment.
Exclusion
- Care-recipient MMSE score of 25 or greater.
- A previous home safety visit.
- Admission to a long-term care facility. - Persons with DAT who are living alone will be excluded because their safety issues are more complex and there is no primary informal caregiver who can make consistent observations about risky behaviors and accidents.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT00459355
Start Date
July 1 2007
End Date
December 1 2011
Last Update
April 28 2015
Active Locations (1)
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1
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, Massachusetts, United States, 01730