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Evaluating Technology-Based Fall Prevention Interventions (FaCT2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03190460
Recruitment Status : Completed
First Posted : June 16, 2017
Results First Posted : January 20, 2021
Last Update Posted : June 7, 2022
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Hilaire Thompson, University of Washington

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.

Condition or disease Intervention/treatment Phase
Falls (Accidents) in Old Age Other: Cognitive Training Other: Technology-based Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Influence of Cognitive Training on Fall Prevention in At Risk Older Adults
Actual Study Start Date : February 15, 2017
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

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.

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




Primary Outcome Measures :
  1. Falls [ Time Frame: 16 weeks ]
    Falls and Injurious Falls as per Fall Calendar


Secondary Outcome Measures :
  1. Disability [ Time Frame: 8 weeks, 16 weeks, 20 weeks. ]
    Gill Disability Scale

  2. Cognitive Assessment [ Time Frame: 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)

  3. Gait Assessment [ Time Frame: 8 weeks, 16 weeks, 20 weeks ]
    Assessment of Gait Parameters using APDM sensor system

  4. Balance Assessment [ Time Frame: 8 weeks, 16 weeks, 20 weeks ]
    Assessment of Balance using APDM sensor system



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 89 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03190460


Locations
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United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Hilaire Thompson University of Washington
  Study Documents (Full-Text)

Documents provided by Hilaire Thompson, University of Washington:
Informed Consent Form  [PDF] June 6, 2018

Publications:
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Responsible Party: Hilaire Thompson, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT03190460    
Other Study ID Numbers: 50219
R21NR015541 ( U.S. NIH Grant/Contract )
First Posted: June 16, 2017    Key Record Dates
Results First Posted: January 20, 2021
Last Update Posted: June 7, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No