DementiaPhase 2NCT04478149
A Comprehensive Fall Prevention System for Memory Care: Final Feasibility and Randomized Controlled Study
A Phase 2 study testing SafelyYou in people with Dementia, run by SafelyYou.
Trial summary
This study tests novel technology using computer vision and remote clinical review to reduce falls for residents with dementia in assisted living communities. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia
- What is being tested?
- SafelyYou
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2023to 31 Dec 2023
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Living in a participating assisted living facility and suffering from dementia
Who cannot join
- -
About this study
This study tests novel technology using computer vision and remote clinical review to reduce falls for residents with dementia in assisted living communities.
- Conditions
- Dementia
- Being tested
- SafelyYou, Control
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SafelyYouDevice
technology to detect and prevent falls
ControlOther
technology present but not activated
| Study group | Role | What they receive |
|---|---|---|
| Active Cameras | Experimental | active cameras in the room Receives: Device: SafelyYou |
| Inactive Cameras | Sham comparator | camera in the room, not activated Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opt-in rate
participants enrolling
Measured: through study completion, an average of 1 year
Number of falls
fall incidents
Measured: through study completion, an average of 1 year
Number of ER visits
fall incidents requiring emergency transportation
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start31 Oct 2023 (estimated)
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Waitlist control
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SafelyYou
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478149
- Sponsor's protocol ID
- 241755
- Status last verified
- May 2022
- First submitted
- 15 Jul 2020
- Last updated
- 9 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Fall Prevention System for Memory Care: Final Feasibility and Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04478149
- Acronym / sponsor ID
- 241755
- Conditions
- Dementia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- SafelyYouIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2023 (estimated)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 20 Jul 2020 (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.
This study tests novel technology using computer vision and remote clinical review to reduce falls for residents with dementia in assisted living communities.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Waitlist control
| Arm | Type | Receives |
|---|---|---|
| Active Cameras | Experimental | Device: SafelyYouactive cameras in the room |
| Inactive Cameras | Sham comparator | Other: Controlcamera in the room, not activated |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Living in a participating assisted living facility and suffering from dementia
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| SafelyYoutechnology to detect and prevent falls | Device | Active Cameras |
| Controltechnology present but not activated | Other | Inactive Cameras |
Primary outcome
Opt-in rate
Time frame: through study completion, an average of 1 year
participants enrolling
Number of falls
Time frame: through study completion, an average of 1 year
fall incidents
Number of ER visits
Time frame: through study completion, an average of 1 year
fall incidents requiring emergency transportation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SafelyYou in people with Dementia, run by SafelyYou.
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 1 inclusion and 1 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 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Opt-in rate (time frame: through study completion, an average of 1 year). 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 9 May 2022.