NCT00459355

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 11, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

September 29, 2014

Completed
Last Updated

April 28, 2015

Status Verified

August 1, 2014

Enrollment Period

2.8 years

First QC Date

April 6, 2007

Results QC Date

August 21, 2014

Last Update Submit

April 6, 2015

Conditions

Alzheimer's DiseaseDementia

Keywords

Alzheimer's diseaseDementiaSafetyHome Care Services

Outcome Measures

Primary Outcomes (2)

  • Caregiver Strain

    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

    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 Outcomes (1)

  • Care Recipient Risky Behaviors and Accidents

    3 months after baseline

Study Arms (2)

Home Safety Toolkit

EXPERIMENTAL

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

Conventional Safety Checklist

NO INTERVENTION

Comparison group received a conventional home safety checklist

Interventions

Home Safety ToolkitBEHAVIORAL

Health literacy-verified booklet and home safety items to promote competence to make home safety modifications.

Home Safety Toolkit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

Bedford, Massachusetts, 01730, United States

Location

Related Publications (2)

  • Horvath KJ, Trudeau SA, Rudolph JL, Trudeau PA, Duffy ME, Berlowitz D. Clinical trial of a home safety toolkit for Alzheimer's disease. Int J Alzheimers Dis. 2013;2013:913606. doi: 10.1155/2013/913606. Epub 2013 Sep 29.

    PMID: 24195007RESULT

  • Lambe S, Cantwell N, Islam F, Horvath K, Jefferson AL. Perceptions, knowledge, incentives, and barriers of brain donation among African American elders enrolled in an Alzheimer's research program. Gerontologist. 2011 Feb;51(1):28-38. doi: 10.1093/geront/gnq063. Epub 2010 Aug 2.

    PMID: 20679141RESULT

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Dr. Kathy Horvath
Organization
Bedford VA Medical Center
Kathy.Horvath@va.gov
781-687-2006

Study Officials

  • Kathy J Horvath, PhD RN

    Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2007

First Posted

April 11, 2007

Study Start

July 1, 2007

Primary Completion

May 1, 2010

Study Completion

December 1, 2011

Last Updated

April 28, 2015

Results First Posted

September 29, 2014

Record last verified: 2014-08

Locations

US(1)