Trial Outcomes & Findings for Home Safety Clinical Trial for Alzheimer's Disease (NCT NCT00459355)
NCT ID: NCT00459355
Last Updated: 2015-04-28
Results Overview
Caregiver Strain was measured by the MBRC Caregiver Strain Index; scores ranged from 0 - 15 with higher scores indicating more strain.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
254 participants
Primary outcome timeframe
3 months after baseline
Results posted on
2015-04-28
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
140
|
114
|
|
Overall Study
COMPLETED
|
120
|
96
|
|
Overall Study
NOT COMPLETED
|
20
|
18
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Subject no longer met inc criteria
|
20
|
18
|
Baseline Characteristics
Home Safety Clinical Trial for Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Home Safety Toolkit
n=120 Participants
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
n=96 Participants
Received conventional home safety checklist
|
Total
n=216 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
caregiver
|
70.6 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
69.4 years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
NA years
STANDARD_DEVIATION NA • n=5 Participants
|
|
Age, Continuous
care-recipient
|
80.4 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
80.9 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
NA years
STANDARD_DEVIATION NA • n=5 Participants
|
|
Gender
Female
|
49 participants
n=5 Participants
|
38 participants
n=7 Participants
|
87 participants
n=5 Participants
|
|
Gender
Male
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
120 participants
n=5 Participants
|
96 participants
n=7 Participants
|
216 participants
n=5 Participants
|
|
Physical Self Maintenance Scale
|
14.6 Units on a scale
STANDARD_DEVIATION 4.3 • n=5 Participants
|
15.1 Units on a scale
STANDARD_DEVIATION 4.0 • n=7 Participants
|
NA Units on a scale
STANDARD_DEVIATION NA • n=5 Participants
|
|
Mini Mental State Exam
|
12.4 Units on a scale
STANDARD_DEVIATION 6.6 • n=5 Participants
|
13.0 Units on a scale
STANDARD_DEVIATION 6.9 • n=7 Participants
|
NA Units on a scale
STANDARD_DEVIATION NA • n=5 Participants
|
|
Functional Activities Questionnaire
|
25.8 Units on a scale
STANDARD_DEVIATION 4.1 • n=5 Participants
|
26.4 Units on a scale
STANDARD_DEVIATION 3.1 • n=7 Participants
|
NA Units on a scale
STANDARD_DEVIATION NA • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months after baselineCaregiver Strain was measured by the MBRC Caregiver Strain Index; scores ranged from 0 - 15 with higher scores indicating more strain.
Outcome measures
| Measure |
Home Safety Toolkit
n=60 Participants
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
n=48 Participants
non-intervention group received conventional home safety checklist
|
|---|---|---|
|
Caregiver Strain
|
5.95 units on a scale
Standard Deviation 3.17
|
6.96 units on a scale
Standard Deviation 3.86
|
PRIMARY outcome
Timeframe: 3 months after baselineCaregiver 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.
Outcome measures
| Measure |
Home Safety Toolkit
n=60 Participants
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
n=48 Participants
non-intervention group received conventional home safety checklist
|
|---|---|---|
|
Caregiver Self-efficacy
|
1350.30 units on a scale
Standard Deviation 197.18
|
1305.65 units on a scale
Standard Deviation 203.36
|
SECONDARY outcome
Timeframe: 3 months after baselineThe 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.
Outcome measures
| Measure |
Home Safety Toolkit
n=60 Participants
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
n=48 Participants
non-intervention group received conventional home safety checklist
|
|---|---|---|
|
Care Recipient Risky Behaviors and Accidents
|
33.95 number of risky behaviors and accidents
Standard Deviation 32.57
|
37.44 number of risky behaviors and accidents
Standard Deviation 37.04
|
Adverse Events
Home Safety Toolkit:Care Recipients
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Checklist:Care Recipients
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Home Safety Toolkit:Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Checklist:Caregivers
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Home Safety Toolkit:Care Recipients
n=70 participants at risk
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:Care Recipients
n=57 participants at risk
Control group receives conventional list of home safety recommendations
|
Home Safety Toolkit:Caregivers
n=70 participants at risk
Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.
|
Checklist:Caregivers
n=57 participants at risk
Control group receives conventional list of home safety recommendations
|
|---|---|---|---|---|
|
General disorders
Death
|
2.9%
2/70 • The caregiver reported events to the investigator during 3 months of study participation.
|
0.00%
0/57 • The caregiver reported events to the investigator during 3 months of study participation.
|
0.00%
0/70 • The caregiver reported events to the investigator during 3 months of study participation.
|
0.00%
0/57 • The caregiver reported events to the investigator during 3 months of study participation.
|
Other adverse events
| Measure |
Home Safety Toolkit:Care Recipients
n=70 participants at risk
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:Care Recipients
n=57 participants at risk
Control group receives conventional list of home safety recommendations
|
Home Safety Toolkit:Caregivers
n=70 participants at risk
Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.
|
Checklist:Caregivers
n=57 participants at risk
Control group receives conventional list of home safety recommendations
|
|---|---|---|---|---|
|
General disorders
Unanticipated hospitalization
|
11.4%
8/70 • Number of events 8 • The caregiver reported events to the investigator during 3 months of study participation.
|
14.0%
8/57 • Number of events 8 • The caregiver reported events to the investigator during 3 months of study participation.
|
0.00%
0/70 • The caregiver reported events to the investigator during 3 months of study participation.
|
1.8%
1/57 • Number of events 1 • The caregiver reported events to the investigator during 3 months of study participation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place