FallScape for Falling Prevention

(FS-D Trial)

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Brookside Research & Development Company

Disqualifiers: Terminal illness, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new technology called FallScape for Dementia (FS-D) to help prevent falls in individuals with Alzheimer's disease or related dementias who live at home. The goal is to improve communication and encourage safer behaviors to reduce falls, which are costly and can lead to serious injuries. The trial seeks caregivers who spend at least two hours a day with someone experiencing memory loss, and individuals with dementia who have recently fallen and can walk a short distance. This innovative approach aims to empower caregivers and those with memory loss to better understand and manage fall risks, ultimately helping families keep their loved ones safe at home. As an Early Phase 1 trial, this research focuses on understanding how the technology works in people, offering participants the opportunity to be among the first to benefit from this new approach.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the FallScape for Dementia (FS-D) intervention is safe for persons with Alzheimer's disease or a related dementia?

Research has shown that the FallScape for Dementia (FS-D) program offers a new method to help prevent falls in individuals with Alzheimer's or similar conditions. Although specific safety data for this program is limited, similar multimedia programs have been used successfully without major safety concerns.

This trial is in its early stages, focusing primarily on participants' ability to handle the program. Early trials like this involve careful monitoring to ensure safety. Essentially, this phase is crucial for identifying any side effects or risks.

For those considering joining this trial, participant safety remains a top priority. The researchers will closely monitor participants' reactions to ensure the program is safe and manageable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FallScape intervention for Alzheimer's and dementia patients because it offers a unique, personalized approach to fall prevention. Unlike standard treatments that often rely on medication or generic exercise programs, FallScape uses tailored video simulations to help patients and their caregivers anticipate and manage fall risks in real-world scenarios. This innovative method actively engages both the patient and caregiver, potentially improving awareness and response to fall hazards, which could lead to more effective prevention strategies.

What evidence suggests that the FallScape for Dementia intervention is effective for preventing falls in persons with Alzheimer's disease or related dementias?

Research has shown that FallScape for Dementia (FS-D) is a promising tool for reducing falls in people with Alzheimer's and similar conditions. It employs engaging videos and activities to help caregivers and those with memory loss understand and change behaviors that might lead to falls. A similar program demonstrated about a 50% reduction in falls among participants. This trial will evaluate the FS-D intervention, which could significantly lower the risk of falls in this vulnerable group, potentially helping them stay at home longer and improving their quality of life. ^{1 2 4 6 7}

Who Is on the Research Team?

Victoria Panzer, MA, EdM, PhD

Principal Investigator

Brookside Research & Development

Are You a Good Fit for This Trial?

This trial is for people with Alzheimer's or related dementias who are at moderate to high risk of falling and live at home. Caregivers will use a new technology called FallScape for Dementia (FS-D) designed to prevent falls by improving communication and changing behaviors.

Inclusion Criteria

I can walk at least six feet on my own or with help.

I have Alzheimer's or related dementia and have fallen at least twice last year or once with injury.

Caregivers must have access to a telephone

Exclusion Criteria

Caregivers cannot have cognitive impairment or dementia

Caregivers cannot have a terminal illness with survival less than 6 months

Caregivers cannot be professional caregivers

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Visit and Pre-test

Initial visit includes informed consent, initial interview, and pre-test with video clips to assess fall threat awareness

1 day

1 visit (in-person)

Treatment

Daily multimedia sessions using FS-D intervention, with weekly electronic postcard submissions and weekly support calls

4 weeks

Daily sessions (virtual), weekly calls (virtual)

Follow-up

Follow-up interview and post-test with video clips to assess fall threat awareness, continued weekly postcard submissions and monthly calls

6 months

1 follow-up visit (in-person), monthly calls (virtual)

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The intervention being tested is FallScape for Dementia (FS-D), an innovative multimedia tool aimed at caregivers of persons with dementia. It seeks to reduce the frequency of falls by enhancing understanding of fall risks and promoting preventive behavior changes.

How Is the Trial Designed?

Group I: FS-D Intervention Experimental Treatment 1 Intervention

All dyads will receive the FS-D intervention

Who Is Running the Clinical Trial?

Brookside Research & Development Company

Lead Sponsor

Trials

2

Recruited

120+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06656897

NCT06656897 | Preliminary Clinical Trial- FallScape-D 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 ...

2. fallscape.org fallscape.org/dnloads/FScpResEvid.pdf

21st Century Falls Prevention- FallsTalk Behavioral ... The Multimedia Fall. Prevention program (FallScape) is designed to address the needs of seniors ranging from active community dwellers to residents of long term ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8437077/

Efficacy of exercise-based interventions in preventing falls ... In this systematic review and meta-analysis of published research, exercise-based interventions were found to reduce falls by approximately 30% compared with ...

4. research.aota.org research.aota.org/ajot/article/65/5/532/5563/Effectiveness-of-Interventions-to-Prevent-Falls-in

Effectiveness of Interventions to Prevent Falls in People With ... Results indicated that the intervention led to an approximately 50% reduction in the number of residents who experienced at least one fall. This ...

5. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/abs/10.1002/alz.066371

Can a family caregiver provide an evidence‐based falls ... Conclusion. FallsTalk-Caregiver provides an effective means to encourage new falls prevention behaviors to prevent losses of balance and falls.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10977097/

Falls and Alzheimer Disease - PMC A growing body of evidence suggests that an increased risk of falls and functional mobility impairments, such as slowing gait and worsening ...

7. bmcgeriatr.biomedcentral.com bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-021-02641-9

Fall prevention in community-dwelling adults with mild to ... Older adults with dementia fall 2–3 times more than cognitively healthy older adults and 60–80% of people with dementia fall annually.