Home Safety Clinical Trial for Alzheimer's Disease
|ClinicalTrials.gov Identifier: NCT00459355|
Recruitment Status : Completed
First Posted : April 11, 2007
Results First Posted : September 29, 2014
Last Update Posted : April 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease Dementia||Behavioral: Home Safety Toolkit||Phase 1|
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 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 was 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 consisted 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 were 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 were: 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 were: 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 were: 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 was conducted at home visits and interim data collection was done biweekly by phone. A total of 108 subject dyads completed the study, randomly assigned to the control group (N-48 dyads) and intervention group (60 dydads). The length of participation for each caregiver-care recipient dyad was 3 months after which the control group was offered the Home Safety Toolkit. Data analysis used 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||254 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||Clinical Trial of a Home Safety Intervention for Alzheimer's Disease|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||December 2011|
U.S. FDA Resources
Experimental: Home Safety Toolkit
Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.
Behavioral: Home Safety Toolkit
Health literacy-verified booklet and home safety items to promote competence to make home safety modifications.
No Intervention: Conventional Safety Checklist
Comparison group received a conventional home safety checklist
- Caregiver Strain [ Time Frame: 3 months after baseline ]Caregiver Strain was measured by the MBRC Caregiver Strain Index; scores ranged from 0 - 15 with higher scores indicating more strain.
- Caregiver Self-efficacy [ Time Frame: 3 months after baseline ]Caregiver self-efficacy was measured by the Revised Checklist for Caregiving Self-Efficacy; the scale consists of 17 items which are rated from 0 - 100% confidence. The total score is summed from these percentages and ranges from 0 - 1700 where higher scores indicate a higher level of confidence.
- Care Recipient Risky Behaviors and Accidents [ Time Frame: 3 months after baseline ]The Risky Behavior Checklist listed common risky behaviors and accidents exhibited by care recipients with dementia based on previous research. Potential scores ranged from 0 - undetermined. The maximum score is undetermined because the measure represents the caregiver count of the number of times an incident occurred. In this study, sum scores ranged from 0 - 180.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00459355
|United States, Massachusetts|
|Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA|
|Bedford, Massachusetts, United States, 01730|
|Principal Investigator:||Kathy J Horvath, PhD RN||Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA|