Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Department of Veterans Affairs Boston Medical Center |
---|---|
Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00459355 |
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.
Condition | Intervention | Phase |
---|---|---|
Alzheimer's Disease Dementia |
Behavioral: Home Safety Toolkit |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Clinical Trial of a Home Safety Intervention for Alzheimer's Disease |
Estimated Enrollment: | 320 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1
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.
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Scott A Trudeau, OTR | (781) 687-2904 | scott.trudeau@va.gov |
Contact: Rosemary Tolwinski | (781) 687-2848 |
United States, Massachusetts | |
Edith Nourse Rogers Memorial Veterans Hospital | Recruiting |
Bedford, Massachusetts, United States, 01730 | |
Contact: Annamaria Valentine, BA 781-687-2887 AnnaMaria.Valentine@va.gov | |
Contact: Kathy J Horvath, PhD RN (781) 687-2006 kathy.horvath@va.gov | |
Principal Investigator: Kathy J Horvath, PhD RN | |
Sub-Investigator: Dan R. Berlowitz, MD MPH |
Principal Investigator: | Kathy J Horvath, PhD RN | Edith Nourse Rogers Memorial Veterans Hospital |
Responsible Party: | Department of Veterans Affairs ( Horvath, Kathy - Principal Investigator ) |
Study ID Numbers: | NRH 05-056 |
Study First Received: | April 6, 2007 |
Last Updated: | March 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00459355 History of Changes |
Health Authority: | United States: Federal Government |
Alzheimer's disease Dementia Safety Home Care Services |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases Neurodegenerative Diseases |
Brain Diseases Dementia Cognition Disorders Delirium |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Nervous System Diseases Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Tauopathies Brain Diseases Dementia |