Trial Outcomes & Findings for Evaluating Technology-Based Fall Prevention Interventions (NCT NCT03190460)
NCT ID: NCT03190460
Last Updated: 2022-06-07
Results Overview
Falls and Injurious Falls as per Fall Calendar
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
16 weeks
Results posted on
2022-06-07
Participant Flow
Participant milestones
| Measure |
Intervention
Cognitive Training: Web-based cognitive training intervention targeting specific cognitive tasks. Subjects complete 3 training sessions per week with at least 24 hours in between sessions.
|
Education
Technology-based Education: Subjects complete 16 web-based educational modules on healthy aging content. Following each module, subjects complete a learning reflection.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
20
|
|
Overall Study
COMPLETED
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
37
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating Technology-Based Fall Prevention Interventions
Baseline characteristics by cohort
| Measure |
Intervention
n=40 Participants
Cognitive Training: Web-based cognitive training intervention targeting specific cognitive tasks. Subjects complete 3 training sessions per week with at least 24 hours in between sessions.
|
Education
n=20 Participants
Technology-based Education: Subjects complete 16 web-based educational modules on healthy aging content. Following each module, subjects complete a learning reflection.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
40 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Age, Continuous
|
77.2 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
75.9 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
76.8 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
20 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksFalls and Injurious Falls as per Fall Calendar
Outcome measures
| Measure |
Intervention
n=40 Participants
Cognitive Training: Web-based cognitive training intervention targeting specific cognitive tasks. Subjects complete 3 training sessions per week with at least 24 hours in between sessions.
|
Education
n=20 Participants
Technology-based Education: Subjects complete 16 web-based educational modules on healthy aging content. Following each module, subjects complete a learning reflection.
|
|---|---|---|
|
Falls
|
0.6 number of falls
Standard Error 0.2
|
0.6 number of falls
Standard Error 0.3
|
SECONDARY outcome
Timeframe: 8 weeks, 16 weeks, 20 weeks.Gill Disability Scale
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 weeks, 16 weeks, 20 weeksCANTAB Battery (Simple response time, one touch stockings of Cambridge, Stop Signal Task, Spatial Working Memory, Verbal Recognition Memory, Rapid Visual Information Processing)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 weeks, 16 weeks, 20 weeksAssessment of Gait Parameters using APDM sensor system
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 weeks, 16 weeks, 20 weeksAssessment of Balance using APDM sensor system
Outcome measures
Outcome data not reported
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Hilaire Thompson
University of Washington School of Nursing
Phone: 2066165641
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place