Evaluating Technology-Based Fall Prevention Interventions

Falls (Accidents) in Old Age Clinical Trial

— FaCT2  

Official title:

Influence of Cognitive Training on Fall Prevention in At Risk Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03190460
• Other study ID #: 50219
• Secondary ID: R21NR015541
• Status: Completed
• Phase: N/A
• Start date: February 15, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: May 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Approximately one in three older adults fall annually and it is the primary cause of traumatic injury in older adults. While exercise and balance programs have been shown to be effective in reducing fall risk, maintaining behavior change is known to be difficult. Thus additional interventions need to be validated to add to our current armamentarium to reduce falls in older adults. Cognitive training (CT) involves exercises that target specific cognitive tasks, such as memory or processing speed. It has been speculated that routinely performing such tasks may increase functional ability. Recent work has pointed to an increased risk of falls in community-dwelling older adults who have alterations in specific cognitive tasks. Thus the purpose of the proposed study is to demonstrate the feasibility and to explore the effectiveness of a 16 week CT intervention to reduce risk and incidence of fall and improve outcomes up to 1 month post-intervention in a group of community dwelling older adults at risk for fall.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 28, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 89 Years

Eligibility

Inclusion Criteria:

• 65-89 years old
• speak and read English
• live within 30 miles of the University of Washington
• a score of 4 or higher on the Memory Impairment Screen (MIS-T)
• regular access to a computer with internet capability (whether at home, friend/family, community center, public library, or other)
• a positive response to any of the following three fall related questions: i) Have you had two or more falls in the prior 12 months? ii) Are you responding to the advertisement because of a recent fall? iii) Do you have difficulty with walking or balance?
• <53 seconds on 90 second balance test or gait speed <1m/sec.

Exclusion Criteria:

• current participation in formal cognitive training program
• currently bedridden or wheelchair dependent

Related Conditions & MeSH terms

• Falls (Accidents) in Old Age

Intervention

Other:
• 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.
• Technology-based Education
Subjects complete 16 web-based educational modules on healthy aging content. Following each module, subjects complete a learning reflection.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Thompson HJ, McGough E, Demiris G. Falls and Cognitive Training 2 (FaCT2) study protocol: a randomised controlled trial exploring cognitive training to reduce risk of falls in at-risk older adults. Inj Prev. 2020 Aug;26(4):370-377. doi: 10.1136/injuryprev-2019-043332. Epub 2019 Aug 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Falls	Falls and Injurious Falls as per Fall Calendar	16 weeks
Secondary	Disability	Gill Disability Scale	8 weeks, 16 weeks, 20 weeks.
Secondary	Cognitive Assessment	CANTAB Battery (Simple response time, one touch stockings of Cambridge, Stop Signal Task, Spatial Working Memory, Verbal Recognition Memory, Rapid Visual Information Processing)	8 weeks, 16 weeks, 20 weeks
Secondary	Gait Assessment	Assessment of Gait Parameters using APDM sensor system	8 weeks, 16 weeks, 20 weeks
Secondary	Balance Assessment	Assessment of Balance using APDM sensor system	8 weeks, 16 weeks, 20 weeks