Preliminary Clinical Trial- FallScape-D

NCT06656897 | Active Not Recruiting Early Phase 1

• 3 other identifiers: FallScape for CG1R43AG071360-01A13R43AG071360-01A1S1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Falls

Outcome Measures

Primary Outcomes (3)

• Fall Threat Awareness

  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.

  One month from Pre-test to Post-test

• Rate of Falls

  The CG will record falls and injury falls daily and submit a weekly electronic postcard. The falls rate will be calculated monthly.

  Monthly for up to six months

• Falls Prevention Behaviors

  The CG will record falls prevention behaviors daily and submit a weekly electronic postcard. The number of fall prevention behaviors is the total number recorded.

  Daily for up to six months

Secondary Outcomes (1)

• Change of Residence

  Weekly for up to six months

Study Arms (1)

FS-D Intervention

EXPERIMENTAL

All dyads will receive the FS-D intervention

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

Interventions

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

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.

FS-D Intervention

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Brookside Research & Development Company: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Brookside Research & Development

Coupeville, Washington, 98239, United States

Location

MeSH Terms

Interventions

Amyloid beta-Protein Precursor

Intervention Hierarchy (Ancestors)

Amyloidogenic Proteins; Amyloid; Proteins; Amino Acids, Peptides, and Proteins; Membrane Proteins; Protein Precursors; Protease Nexins; Proteinase Inhibitory Proteins, Secretory

Study Officials

• Victoria Panzer, MA, EdM, PhD

  Brookside Research & Development

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 24, 2024
• Study Start: March 12, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)