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Clinical Trials in the USA / NCT06656897
Active, not recruiting Phase EARLY_PHASE1

Preliminary Clinical Trial- FallScape-D

NCT06656897 · tracked via the Priya Life Science USA tracker
Sponsor
Brookside Research & Development Company
Phase
Phase EARLY_PHASE1
Started
2024-03-12
Last updated
2024-10-24

Condition(s) studied

Falls

Investigational drug(s) / intervention(s)

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

FallScape for Persons with Alzheimer's disease or a related Dementia (FS-D): FS-D is a multimedia behavioral intervention for use by family Caregivers (CG) of Persons with Alzheimer's disease or a related dementia (PwADRD) who are living at home and classified as at moderate to high risk for falls. FS-D will create, customize and support CG-provided daily multimedia sessions for PwADRD using structured learning techniques.

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.

Eligibility

Sex
ALL
Min age
21 Years
Max age
99 Years
Healthy volunteers
No
Inclusion CGs will: * be medically stable adults; * have at least two hours of unpaid daily contact with a PwADRD; * have access to a telephone; * have basic computer skills; * can read informed consent; * speak English. Persons with Alzheimers Disease and Related Dementias will: * live at home; * be medically stable; * have had at least two falls in the last year or one fall with injury (moderate to high fall risk); * able to ambulate at least six feet with or without an assistive device and/or contact guard; * speak English; * be able to verbally express their thoughts and willingness to participate. Exclusion CGs will not: * be a professional CG; * have a terminal illness with survival \<6months; * have cognitive impairment or dementia; * have severe visual or hearing impairment; * be unable to use a telephone; * lack basic computer skills; * be unable to read; * be unable to speak English. Persons with Alzheimers Disease and Related Dementias will not: * have a terminal illness with survival \<6months; * have MMSE \<10; * have severe visual or hearing impairment; * be wheelchair or bed bound; * very recently diagnosed with memory impairment (\<1 month); * be unable to communicate; * be unwilling to participate.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Brookside Research & Development Coupeville Washington

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06656897 on ClinicalTrials.gov ↗ ← All trials in the USA