FallsEarly Phase 1FS-DNCT06656897
Preliminary Clinical Trial- FallScape-D
A Early Phase 1 study testing FallScape for Persons with Alzheimer's disease or a related Dementia (FS-D) in people with Falls, run by Brookside Research & Development Company at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Falls
- What is being tested?
- FallScape for Persons with Alzheimer's disease or a related Dementia (FS-D)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2024to 31 Dec 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 14Show fewer
- 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.
Who cannot join
- 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;
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brookside Research & Development
Coupeville, Washington, 98239
About this study
Official title: Prototype Multimedia ADRD Falls Prevention System for Family Caregivers
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.
Read the detailed description
Preliminary Clinical Trial Study Description: The team will recruit participants consisting of dyads from Washington (WA) state and surrounding Counties with the assistance of Alzheimer's Assoc. WA State Chapter if necessary. Participants representing approximate proportions of women, minority groups and PwD at moderate to high fall risk with the following diagnoses (approximate percentages): Alzheimer's (70%), vascular (10%), Lewy-body (10%) Parkinson's disease (10%) dementias will be recruited. Recruitment will be conducted in 4-6 waves. Each wave will focus on one geographic area, with special attention to minority recruitment. The investigators expect 80% to express interest, 50% of these to qualify and consent and participate. In each wave, 10-15 CG-PwD dyads will be screened, 5-10 dyads will be eligible and 3-5 dyads enrolled in the study. Enrollment of a total of 25 dyads is expected to allow for 20% drop-outs due to health issues which are anticipated in this population. All dyads will receive the FS-D intervention. The Preliminary Clinical Trial will utilize a longitudinal Pre-Post test (Repeated Measures) Mixed Method design, in which the control for each participant is the participant. Informed consent will be obtained from the CG for both dyad members, if there is a legally appointed Conservator for the PwD, the Conservator must provide consent before any study participation can occur. The PwD will provide verbal consent at each encounter. After obtaining Informed Consent, the intervention will begin with an Initial visit which will constitute a Pre-test. During this visit a research team member will conduct an Initial interview to gather the CG's specific concerns about preventing falls, in addition to some basic information about the PwD. Artificial Intelligence (AI) algorithms or computer programs will consider these concerns and the other characteristics of the PwD described and create a customized training set of Mm vignettes, these are short (less than 2 minutes) videos with accompanying stories. During this visit, the CG will also describe any 'Situations' that could cause the PwD to fall and complete standardized measures of self-efficacy and burden. The PwD will complete a Mm Evaluation in which five very short (less than 30 seconds) video clips will be shown, these do not have stories. The Mm Evaluation will include the first five of ten standardized clips of new places and circumstances. The video clips will be shown in an order randomized by the computer program. For each clip, the PwD will be asked to identify anything that could make someone fall. The CG will be shown how to use FS-D to conduct a daily Mm session using the vignettes and the intervention protocol which is tailored to meet the dyad's specific requirements, complete a daily log entry and submit a weekly electronic postcard using FS-D. After the Initial study visit, the CG will conduct a daily session for the PwD. These sessions will be shorter than 15 minutes and guided by the FS-D software. As each daily session takes place, the AI will tailor the session using structured learning techniques and will set up the next session based on how the PwD does that day. Each day the CG will record any falls prevention behaviors that have been noted, if the PwD had any falls that day, how often any Loss of Balance occurs, if either was away from home overnight and if any overnight absence from home was temporary or permanent. These daily records will be compiled by the FS-D software into a weekly report to be submitted by the CG by electronic postcard. Once a week, a research team member will call the CG to support them and determine how the sessions are going. Based on CG feedback, the Mm session difficulty can be adjusted using special computer entries during weekly calls. After a month, a Follow-up interview will be conducted in which the CG will also describe any new 'Situations' that could cause the PwD to fall and complete standardized measures. The PwD will have a Post-Test which will include the second five of ten standardized clips which were previously randomized by the computer program and asked to identify anything noticed that could make someone fall. After the Follow-up interview, no further Mm sessions will occur. The CG will continue to record behaviors, falls and overnight absence from home or hospitalizations; medical issues, and treatment or mobility changes and submit a weekly electronic postcard. The research team member will call the CG two weeks after the Follow-up and then once a month in order to encourage the CG to continue to submit the weekly postcard and find out about any falls or other occurrences. Monthly calls will continue until endpoint (PwD no longer meets eligibility criteria or is no longer living at home) or up to six months if the PwD continues to be eligible.
- Conditions
- Falls
- Being tested
- FallScape for Persons with Alzheimer's disease or a related Dementia (FS-D)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FallScape for Persons with Alzheimer's disease or a related Dementia (FS-D)Behavioural
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 group | Role | What they receive |
|---|---|---|
| FS-D Intervention | Experimental | All dyads will receive the FS-D intervention Receives: Behavioral: FallScape for Persons with Alzheimer's disease or a related Dementia (FS-D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Daily for up to six months
Secondary outcomes (1)
Change of Residence
CG will report if a permanent change of residence has occurred by weekly electronic postcard.
Measured: Weekly for up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start12 Mar 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brookside Research & Development Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Victoria Panzer, MA, EdM, PhD, Principal investigator, Brookside Research & Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656897
- Sponsor's protocol ID
- FallScape for CG
- Other IDs
- 1R43AG071360-01A1, 3R43AG071360-01A1S1
- Acronym
- FS-D
- Status last verified
- Sep 2024
- First submitted
- 21 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregate data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prototype Multimedia ADRD Falls Prevention System for Family Caregivers
- ClinicalTrials.gov ID
- NCT06656897
- Acronym / sponsor ID
- FS-D / FallScape for CG
- Conditions
- Falls
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Brookside Research & Development CompanyIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Preliminary Clinical Trial Study Description: The team will recruit participants consisting of dyads from Washington (WA) state and surrounding Counties with the assistance of Alzheimer's Assoc. WA State Chapter if necessary. Participants representing approximate proportions of women, minority groups and PwD at moderate to high fall risk with the following diagnoses (approximate percentages): Alzheimer's (70%), vascular (10%), Lewy-body (10%) Parkinson's disease (10%) dementias will be recruited. Recruitment will be conducted in 4-6 waves. Each wave will focus on one geographic area, with special attention to minority recruitment. The investigators expect 80% to express interest, 50% of these to qualify and consent and participate. In each wave, 10-15 CG-PwD dyads will be screened, 5-10 dyads will be eligible and 3-5 dyads enrolled in the study. Enrollment of a total of 25 dyads is expected to allow for 20% drop-outs due to health issues which are anticipated in this population. All dyads will receive the FS-D intervention. The Preliminary Clinical Trial will utilize a longitudinal Pre-Post test (Repeated Measures) Mixed Method design, in which the control for each participant is the participant. Informed consent will be obtained from the CG for both dyad members, if there is a legally appointed Conservator for the PwD, the Conservator must provide consent before any study participation can occur. The PwD will provide verbal consent at each encounter. After obtaining Informed Consent, the intervention will begin with an Initial visit which will constitute a Pre-test. During this visit a research team member will conduct an Initial interview to gather the CG's specific concerns about preventing falls, in addition to some basic information about the PwD. Artificial Intelligence (AI) algorithms or computer programs will consider these concerns and the other characteristics of the PwD described and create a customized training set of Mm vignettes, these are short (less than 2 minutes) videos with accompanying stories. During this visit, the CG will also describe any 'Situations' that could cause the PwD to fall and complete standardized measures of self-efficacy and burden. The PwD will complete a Mm Evaluation in which five very short (less than 30 seconds) video clips will be shown, these do not have stories. The Mm Evaluation will include the first five of ten standardized clips of new places and circumstances. The video clips will be shown in an order randomized by the computer program. For each clip, the PwD will be asked to identify anything that could make someone fall. The CG will be shown how to use FS-D to conduct a daily Mm session using the vignettes and the intervention protocol which is tailored to meet the dyad's specific requirements, complete a daily log entry and submit a weekly electronic postcard using FS-D. After the Initial study visit, the CG will conduct a daily session for the PwD. These sessions will be shorter than 15 minutes and guided by the FS-D software. As each daily session takes place, the AI will tailor the session using structured learning techniques and will set up the next session based on how the PwD does that day. Each day the CG will record any falls prevention behaviors that have been noted, if the PwD had any falls that day, how often any Loss of Balance occurs, if either was away from home overnight and if any overnight absence from home was temporary or permanent. These daily records will be compiled by the FS-D software into a weekly report to be submitted by the CG by electronic postcard. Once a week, a research team member will call the CG to support them and determine how the sessions are going. Based on CG feedback, the Mm session difficulty can be adjusted using special computer entries during weekly calls. After a month, a Follow-up interview will be conducted in which the CG will also describe any new 'Situations' that could cause the PwD to fall and complete standardized measures. The PwD will have a Post-Test which will include the second five of ten standardized clips which were previously randomized by the computer program and asked to identify anything noticed that could make someone fall. After the Follow-up interview, no further Mm sessions will occur. The CG will continue to record behaviors, falls and overnight absence from home or hospitalizations; medical issues, and treatment or mobility changes and submit a weekly electronic postcard. The research team member will call the CG two weeks after the Follow-up and then once a month in order to encourage the CG to continue to submit the weekly postcard and find out about any falls or other occurrences. Monthly calls will continue until endpoint (PwD no longer meets eligibility criteria or is no longer living at home) or up to six months if the PwD continues to be eligible.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FS-D Intervention | Experimental | Behavioral: FallScape for Persons with Alzheimer's disease or a related Dementia (FS-D)All dyads will receive the FS-D intervention |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | FS-D Intervention |
Primary outcome
Fall Threat Awareness
Time frame: One month from Pre-test to Post-test
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.
Rate of Falls
Time frame: Monthly for up to six months
The CG will record falls and injury falls daily and submit a weekly electronic postcard. The falls rate will be calculated monthly.
Falls Prevention Behaviors
Time frame: Daily for up to six months
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.
1 secondary outcome
Change of Residence
Time frame: Weekly for up to six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Individual participant dataSharing planned: No. Aggregate data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria Panzer, MA, EdM, PhD principal investigator
Brookside Research & Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing FallScape for Persons with Alzheimer's disease or a related Dementia (FS-D) in people with Falls, run by Brookside Research & Development Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fall Threat Awareness (time frame: One month from Pre-test to Post-test). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.