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Home Safety Clinical Trial for Alzheimer's Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00459355
First Posted: April 11, 2007
Last Update Posted: April 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Boston Medical Center
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: August 21, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Health Services Research
Conditions: Alzheimer's Disease
Dementia
Intervention: Behavioral: Home Safety Toolkit

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Home Safety Toolkit

Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.

Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications.

Checklist Group receives conventional home safety checklist

Participant Flow:   Overall Study
    Home Safety Toolkit   Checklist
STARTED   140 [1]   114 [2] 
COMPLETED   120 [3]   96 [4] 
NOT COMPLETED   20   18 
Subject no longer met inc criteria                20                18 
[1] Includes 70 dyads, caregiver/care-recipient
[2] Includes 57 dyads, caregiver + care-recipient
[3] Includes 60 dyads, caregiver + care-recipient
[4] Includes 48 dyads, caregiver + care-recipient



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Sample size calculations indicated that 216 total participants was sufficient for all calculations

Reporting Groups
  Description
Home Safety Toolkit

Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.

Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications.

Checklist Received conventional home safety checklist
Total Total of all reporting groups

Baseline Measures
   Home Safety Toolkit   Checklist   Total 
Overall Participants Analyzed 
[Units: Participants]
 120   96   216 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
     
caregiver   70.6  (11.4)   69.4  (12.9)   NA [1] 
care-recipient   80.4  (6.7)   80.9  (7.2)   NA [1] 
[1] Data are locked
Gender [1] 
[Units: Participants]
     
Female   8   6   14 
Male   52   42   94 
[1] These are care recipients
Gender [1] 
[Units: Participants]
     
Female   49   38   87 
Male   11   10   21 
[1] These are caregivers
Region of Enrollment 
[Units: Participants]
     
United States   120   96   216 
Physical Self Maintenance Scale [1] [2] 
[Units: Units on a scale]
Mean (Standard Deviation)
 14.6  (4.3)   15.1  (4.0)   NA [2] 
[1] Scores range from 6 - 30 with higher scores indicating greater disability
[2] Data are locked
Mini Mental State Exam [1] [2] 
[Units: Units on a scale]
Mean (Standard Deviation)
 12.4  (6.6)   13.0  (6.9)   NA [2] 
[1] Scores range from 0 - 30 with lower scores representing greater cognitive impairment
[2] Data are locked
Functional Activities Questionnaire [1] [2] 
[Units: Units on a scale]
Mean (Standard Deviation)
 25.8  (4.1)   26.4  (3.1)   NA [2] 
[1] Scores range from 0 - 30 with higher scores representing greater disability
[2] Data are locked


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Caregiver Strain   [ Time Frame: 3 months after baseline ]

2.  Primary:   Caregiver Self-efficacy   [ Time Frame: 3 months after baseline ]

3.  Secondary:   Care Recipient Risky Behaviors and Accidents   [ Time Frame: 3 months after baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Kathy Horvath
Organization: Bedford VA Medical Center
phone: 781-687-2006
e-mail: Kathy.Horvath@va.gov


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00459355     History of Changes
Other Study ID Numbers: NRH 05-056
First Submitted: April 6, 2007
First Posted: April 11, 2007
Results First Submitted: August 21, 2014
Results First Posted: September 29, 2014
Last Update Posted: April 28, 2015