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

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

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=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
>=65 years
40 Participants
n=99 Participants
20 Participants
n=107 Participants
60 Participants
n=206 Participants
Age, Continuous
77.2 years
STANDARD_DEVIATION 7.1 • n=99 Participants
75.9 years
STANDARD_DEVIATION 6.6 • n=107 Participants
76.8 years
STANDARD_DEVIATION 6.9 • n=206 Participants
Sex: Female, Male
Female
28 Participants
n=99 Participants
16 Participants
n=107 Participants
44 Participants
n=206 Participants
Sex: Female, Male
Male
12 Participants
n=99 Participants
4 Participants
n=107 Participants
16 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
39 Participants
n=99 Participants
19 Participants
n=107 Participants
58 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
2 Participants
n=107 Participants
2 Participants
n=206 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=99 Participants
2 Participants
n=107 Participants
4 Participants
n=206 Participants
Race (NIH/OMB)
White
38 Participants
n=99 Participants
14 Participants
n=107 Participants
52 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Region of Enrollment
United States
40 participants
n=99 Participants
20 participants
n=107 Participants
60 participants
n=206 Participants

PRIMARY outcome

Timeframe: 16 weeks

Falls and Injurious Falls as per Fall Calendar

Outcome measures

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 weeks

CANTAB 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 weeks

Assessment of Gait Parameters using APDM sensor system

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks, 16 weeks, 20 weeks

Assessment 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

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place