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Home Safety Clinical Trial for Alzheimer's Disease
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, March 2009
First Received: April 6, 2007   Last Updated: March 3, 2009   History of Changes
Sponsors and Collaborators: Department of Veterans Affairs
Boston Medical Center
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00459355
  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.


Condition Intervention Phase
Alzheimer's Disease
Dementia
Behavioral: Home Safety Toolkit
Phase I

Genetics Home Reference related topics: Alzheimer disease
MedlinePlus related topics: Alzheimer's Caregivers Alzheimer's Disease Caregivers Dementia
U.S. FDA Resources
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

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Adherence to recommendations, caregiver self-efficacy, caregiver strain [ Time Frame: 3 months after baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • care recipient risky behaviors and accidents [ Time Frame: 3 months after baseline ] [ Designated as safety issue: No ]

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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00459355

Contacts
Contact: Scott A Trudeau, OTR (781) 687-2904 scott.trudeau@va.gov
Contact: Rosemary Tolwinski (781) 687-2848

Locations
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            
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Kathy J Horvath, PhD RN Edith Nourse Rogers Memorial Veterans Hospital
  More Information

No publications provided

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

Keywords provided by Department of Veterans Affairs:
Alzheimer's disease
Dementia
Safety
Home Care Services

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on May 07, 2009