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Home Safety Clinical Trial for Alzheimer's Disease - NCT00459355-01730(Clinical Trial 167947)



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City:  Bedford
State:  
MA
Zip Code: 01730
Conditions: Alzheimer's Disease - Dementia
Purpose: The purpose of this study is 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.
Study summary: Objectives: The purpose of this research study is to test the effectiveness of a new multimodal educational intervention to improve caregiver competence to create a safer home environment, and decrease risk and accidents to veterans with dementia living in the community. Objective 1: To determine the effect of the Home Safety Toolkit intervention on caregiver self-efficacy, caregiver adherence to home safety recommendations, and caregiver strain. Objective 2: To determine the effect of the Home Safety Toolkit intervention on the frequency of risky behaviors and accidents among care recipients with dementia of the Alzheimer's type living in the community. Research Design: This study is a single-blinded clinical trial with random assignment of subjects to either the intervention group that receives the Home Safety Toolkit Intervention or the control group which receives customary care. Methodology: The sample will consist of primary family caregivers of a person with dementia of the Alzheimer's type (DAT) receiving care at the Bedford VAMC Dementia Outpatient Clinic, the VA Boston HCS, and the Boston University Alzheimer's Disease Center. 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 criteria are: care-recipient MMSE score of 25 or greater; a previous home safety visit; and 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. Time 1 and Time 2 data collection is conducted at home visits and interim data collection is done biweekly by phone. A total of 160 subject dyads will be recruited, 80/group. The length of participation for each caregiver-care recipient dyad is 3 months after which the control group is offered the Home Safety Toolkit. Data analysis will use Multivariate Analysis of Covariance (MANCOVA) to test hypotheses for significant group differences with the following outcome variables: adherence to recommendations; post-intervention caregiver self-efficacy and post-intervention caregiver strain; care-recipient risky behaviors and accidents. Covariates will include: baseline measures of caregiver self-efficacy and caregiver strain, caregiver years of formal education and use of social support resources.
Criteria: Inclusion Criteria: - 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 Criteria: - 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.
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Data Source: ClinicalTrials.gov
Date Processed: June 22, 2010
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