Evaluating Technology-Based Fall Prevention Interventions (FaCT2)

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

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.

Study Overview

• Status: Completed
• Conditions: Falls (Accidents) in Old Age
• Intervention / Treatment: Other: Cognitive Training; Other: Technology-based Education

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 89 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.
Other: Education	Other: Technology-based Education; Subjects complete 16 web-based educational modules on healthy aging content. Following each module, subjects complete a learning reflection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Falls	Falls and Injurious Falls as per Fall Calendar	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability	Gill Disability Scale	8 weeks, 16 weeks, 20 weeks.
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
Gait Assessment	Assessment of Gait Parameters using APDM sensor system	8 weeks, 16 weeks, 20 weeks
Balance Assessment	Assessment of Balance using APDM sensor system	8 weeks, 16 weeks, 20 weeks

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Hilaire Thompson, University of Washington

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2017
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: June 13, 2017
• First Submitted That Met QC Criteria: June 14, 2017
• First Posted (Actual): June 16, 2017

Study Record Updates

• Last Update Posted (Actual): June 7, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 50219; R21NR015541 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No