Home Safety Clinical Trial for Alzheimer's Disease

April 6, 2015 updated by: US Department of Veterans Affairs

Clinical Trial of a Home Safety Intervention for Alzheimer's Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

254

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Bedford, Massachusetts, United States, 01730
        • Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months after baseline
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.
3 months after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Collaborators

Boston Medical Center

Investigators

  • Principal Investigator: Kathy J Horvath, PhD RN, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

April 6, 2007

First Submitted That Met QC Criteria

April 10, 2007

First Posted (Estimate)

April 11, 2007

Study Record Updates

Last Update Posted (Estimate)

April 28, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRH 05-056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dementia

Clinical Trials on Home Safety Toolkit

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe