Phase 1
Completed N=254
Home Safety Clinical Trial for Alzheimer's Disease
Source: ClinicalTrials.gov NCT00459355 ↗Enrolled (actual)
254
Serious AEs
0.8%
Results posted
Sep 2014
Primary outcomePrimary: Caregiver Strain — 5.95; 6.96 units on a scale — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Caregiver Strain |
5.95; 6.96 | <0.0001 sig |
| PRIMARY Caregiver Self-efficacy |
1350.30; 1305.65 | .002 sig |
| SECONDARY Care Recipient Risky Behaviors and Accidents |
33.95; 37.44 | <.0001 sig |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00459355). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.