NCT03190460

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 16, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

January 20, 2021

Completed
Last Updated

June 7, 2022

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

June 13, 2017

Results QC Date

November 2, 2020

Last Update Submit

May 16, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Falls

    Falls and Injurious Falls as per Fall Calendar

    16 weeks

Secondary Outcomes (4)

  • Disability

    8 weeks, 16 weeks, 20 weeks.

  • Cognitive Assessment

    8 weeks, 16 weeks, 20 weeks

  • Gait Assessment

    8 weeks, 16 weeks, 20 weeks

  • Balance Assessment

    8 weeks, 16 weeks, 20 weeks

Study Arms (2)

Intervention

EXPERIMENTAL
Other: Cognitive Training

Education

OTHER
Other: Technology-based Education

Interventions

Web-based cognitive training intervention targeting specific cognitive tasks. Subjects complete 3 training sessions per week with at least 24 hours in between sessions.

Intervention

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

Education

Eligibility Criteria

Age65 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (2)

  • 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.

    PMID: 31451566BACKGROUND
  • Drahota A, Udell JE, Mackenzie H, Pugh MT. Psychological and educational interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2024 Oct 3;10(10):CD013480. doi: 10.1002/14651858.CD013480.pub2.

MeSH Terms

Interventions

Cognitive Training

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Dr. Hilaire Thompson
Organization
University of Washington School of Nursing

Study Officials

  • Hilaire Thompson

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 13, 2017

First Posted

June 16, 2017

Study Start

February 15, 2017

Primary Completion

January 31, 2019

Study Completion

February 28, 2019

Last Updated

June 7, 2022

Results First Posted

January 20, 2021

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations