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NCT06656897 · ClinicalTrials.gov registry record · Early Phase 1

Preliminary Clinical Trial- FallScape-D

A Early Phase 1 study of Falls, sponsored by Brookside Research & Development Company.

Active
Registry status
Early Phase 1
Development phase
24
Enrollment target
1
Study location

NCT06656897: Active Early Phase 1 study of Falls, sponsored by Brookside Research & Development Company.

NCT06656897 is a Early Phase 1 study of Falls that is active but no longer recruiting, run by Brookside Research & Development Company. The registered enrollment target is 24 participants, below the 227-participant average among 7 other Falls trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06656897, a Early Phase 1 study of Falls, is active but no longer recruiting, sponsored by Brookside Research & Development Company.

ACTIVE NOT RECRUITING
Registry status
Early Phase 1
Development phase
24 participants
Enrollment target
1
Study location

Study Summary

Falls are a common and expensive problem, especially in persons with cognitive impairment due to Alzheimer's Disease and Related Dementias (PwADRD). The annual cost of falls is approximately 70 billion dollars, and falls add to the burden of a family caregiver. Injurious falls are a frequent reason people are unable to remain at home, resulting in significantly increased care costs to the family and society. Most falls prevention efforts fail to address the understanding of fall risks, or the need to change the behavior of the PwADRD, the caregiver, or both. In response to a National Institute on Aging request for 'Care technology to sustain in-home living, preserve function and promote effective communication', an innovative falls prevention intervention for use by caregivers of PwADRD who are still living at home and classified as at moderate to high risk for falls will be developed and tested. This new technology is called FallScape for Dementia (FS-D). The innovative caregiver-provided daily treatment uses an engaging multimedia approach and behavioral intervention methods to facilitate communication and encourage change in falls prevention behaviors to reduce PwADRD falls. This new FS-D intervention offers the rare opportunity to empower both the caregiver and the Person with memory loss by breaking the frustrating cycle of failure to recognize what could make an individual fall, or change behavior and may mitigate the burden that results from falls. FS-D is an urgently needed falls prevention intervention for family caregiver use. The economic and quality of life benefits of sustaining in-home living by preventing falls will benefit not only the caregiver and family, but will accrue to all stakeholders for this large, high-risk population.

Primary Outcome

Ten standardized video clips (less than 30 sec. each) are randomized and the first five are shown for the Pre-test; the second five video clips are shown for the Post-test. For each video clip, the PwADRD is asked "What do you notice that could cause a fall?" and each response is documented.

Conditions Studied

Interventions

  • BEHAVIORAL FallScape for Persons with Alzheimer's disease or a related Dementia (FS-D)

Study Locations (1)

Washington

  • Brookside Research & Development - Coupeville

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2024-03-12
Est. Completion 2024-12-31
Phase Early Phase 1

What the registry record for NCT06656897 still lists

NCT06656897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 227-participant average among 7 other Falls trials with a reported enrollment target (89% lower).

The record links to 1 condition, with Falls appearing as the primary indexed condition, and to 1 intervention - of which FallScape for Persons with Alzheimer's disease or a related Dementia (FS-D) is the first listed.

NCT06656897 reports a single indexed study location in Washington.

Frequently Asked Questions

What is clinical trial NCT06656897 about?

NCT06656897 is a clinical study titled "Preliminary Clinical Trial- FallScape-D". Falls are a common and expensive problem, especially in persons with cognitive impairment due to Alzheimer's Disease and Related Dementias (PwADRD). The annual cost of falls is approximately 70 billion dollars, and falls add to the burden of a family caregiver. Injurious falls are a frequent reason ...

What is the current status of trial NCT06656897?

This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 24 participants. The study started on 2024-03-12. Estimated completion is 2024-12-31.

What conditions does trial NCT06656897 study?

This clinical trial studies the following conditions: Falls.

What interventions are being tested in trial NCT06656897?

The interventions under investigation include: FallScape for Persons with Alzheimer's disease or a related Dementia (FS-D) (BEHAVIORAL).

Who is sponsoring clinical trial NCT06656897?

This trial is sponsored by Brookside Research & Development Company, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06656897 being conducted?

This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT06656897, the US trial registry maintained by the National Library of Medicine. NCT06656897 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.