Home Safety Clinical Trial for Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborator:
Boston Medical Center
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00459355
First received: April 6, 2007
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Dementia
Behavioral: Home Safety Toolkit
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Health Services Research
Official Title: Clinical Trial of a Home Safety Intervention for Alzheimer's Disease

Resource links provided by NLM:


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 ]

Enrollment: 254
Study Start Date: July 2007
Study Completion Date: December 2011
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 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 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00459355

Locations
United States, Massachusetts
Bedford VA Medical Center
Bedford, Massachusetts, United States, 01730
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Kathy J Horvath, PhD RN Edith Nourse Rogers Memorial Veterans Hospital
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00459355     History of Changes
Other Study ID Numbers: NRH 05-056
Study First Received: April 6, 2007
Last Updated: August 5, 2014
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on September 22, 2014