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| ID | Type | Description | Link |
|---|---|---|---|
| R21NR015541 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
| |
| Education | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Training | Other | Web-based cognitive training intervention targeting specific cognitive tasks. Subjects complete 3 training sessions per week with at least 24 hours in between sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Falls | Falls and Injurious Falls as per Fall Calendar | 16 weeks |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hilaire Thompson | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31451566 | Background | 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. | |
| 39360568 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Education | Technology-based Education: Subjects complete 16 web-based educational modules on healthy aging content. Following each module, subjects complete a learning reflection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Education |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Falls | Falls and Injurious Falls as per Fall Calendar | Posted | Mean | Standard Error | number of falls | 16 weeks |
|
20 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hilaire Thompson | University of Washington School of Nursing | 2066165641 | hilairet@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 27, 2016 | Dec 29, 2020 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 6, 2018 | Nov 26, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Technology-based Education | Other | Subjects complete 16 web-based educational modules on healthy aging content. Following each module, subjects complete a learning reflection. |
|
| 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 |
Technology-based Education: Subjects complete 16 web-based educational modules on healthy aging content. Following each module, subjects complete a learning reflection.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Disability | Gill Disability Scale | Not Posted | 8 weeks, 16 weeks, 20 weeks. | Participants |
| 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) | Not Posted | 8 weeks, 16 weeks, 20 weeks | Participants |
| Secondary | Gait Assessment | Assessment of Gait Parameters using APDM sensor system | Not Posted | 8 weeks, 16 weeks, 20 weeks | Participants |
| Secondary | Balance Assessment | Assessment of Balance using APDM sensor system | Not Posted | 8 weeks, 16 weeks, 20 weeks | Participants |
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Education | Technology-based Education: Subjects complete 16 web-based educational modules on healthy aging content. Following each module, subjects complete a learning reflection. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |