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: September 26, 2014
Last verified: September 2014
Results First Received: August 21, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   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  
Number of Participants  
[units: participants]
  120     96     216  
Age  
[units: years]
Mean ± Standard Deviation
     
caregiver     70.6  ± 11.4     69.4  ± 12.9     NA  ± NA [1]
care-recipient     80.4  ± 6.7     80.9  ± 7.2     NA  ± NA [1]
Gender [2]
[units: participants]
     
Female     8     6     14  
Male     52     42     94  
Gender [3]
[units: participants]
     
Female     49     38     87  
Male     11     10     21  
Region of Enrollment  
[units: participants]
     
United States     120     96     216  
Study-Specific Measure [4]
[units: Units on a scale]
Mean ± Standard Deviation
  14.6  ± 4.3     15.1  ± 4.0     NA  ± NA [1]
Study-Specific Measure [5]
[units: Units on a scale]
Mean ± Standard Deviation
  12.4  ± 6.6     13.0  ± 6.9     NA  ± NA [1]
Study-Specific Measure [6]
[units: Units on a scale]
Mean ± Standard Deviation
  25.8  ± 4.1     26.4  ± 3.1     NA  ± NA [1]
[1] Data are locked
[2] These are care recipients
[3] These are caregivers
[4] Scores range from 6 - 30 with higher scores indicating greater disability
[5] Scores range from 0 - 30 with lower scores representing greater cognitive impairment
[6] Scores range from 0 - 30 with higher scores representing greater disability



  Outcome Measures
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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: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00459355     History of Changes
Other Study ID Numbers: NRH 05-056
Study First Received: April 6, 2007
Results First Received: August 21, 2014
Last Updated: September 26, 2014
Health Authority: United States: Federal Government