FallsNCT02835248
A Novel System to Detect Falls in Real-life Conditions
An observational study of Falls, run by BioSensics at 1 site in United States.
Trial summary
Medical alert devices with automatic fall detection functionality use accelerometry to detect a fall and can signal for help if the wearer forgets to, or is incapable of, pressing the alert button. This can save lives and prevent complications associated with long periods of time spent on the floor after a fall. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Falls
- What is being tested?
- Fall Detection
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to May 2018
- Phase
- Observational
- 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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Older adult study participants will be recruited from the cohort of participants in the STRIDE Study at the Boston trial site (http://www.stride-study.org/).
Who may be able to join
- Enrolled in the STRIDE Study at the Boston trial site (http://www.stride-study.org/).
Who cannot join
- Uses a medical alert device
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
Medical alert devices with automatic fall detection functionality use accelerometry to detect a fall and can signal for help if the wearer forgets to, or is incapable of, pressing the alert button. This can save lives and prevent complications associated with long periods of time spent on the floor after a fall. In this project, the sensitivity and false alarm rate of a commercially available medical alert device will be tested in a population of 200 community-dwelling older adults.
- Conditions
- Falls
- Being tested
- Fall Detection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fall DetectionOther
Also called ActivePERS
All participants will wear a device configured to detect falls.
| Study group | Role | What they receive |
|---|---|---|
| Primary | Older adult study participants will be recruited from the cohort of participants in the STRIDE Study at the Boston trial site (http://www.stride-study.org/). Receives: Other: Fall Detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity and specificity of ActivePERS fall detection algorithms will be measured by comparing the occurence of falls detected by the wearable device to study participant self reported falls
Measured: 2 years
Secondary outcomes (1)
Near falls as measured by patient self report
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startSep 2015
- Primary completionMay 2018
- Study completionMay 2018
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioSensics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Brigham and Women's Hospital, Spaulding Rehabilitation Hospital
- Responsible party
- Sponsor
- Investigators
- Shalendar Bhasin, MD, Principal investigator, Brigham and Women's HospitalJoseph T Gwin, PhD, Principal investigator, BioSensicsPaolo Bonato, PhD, Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835248
- Sponsor's protocol ID
- 15-0930-01
- Status last verified
- Jul 2018
- First submitted
- 8 Jul 2016
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel System to Detect Falls in Real-life Conditions
- ClinicalTrials.gov ID
- NCT02835248
- Acronym / sponsor ID
- 15-0930-01
- Conditions
- Falls
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- BioSensicsIndustry (pharma, biotech, devices)
- Collaborators
- Brigham and Women's Hospital, Spaulding Rehabilitation Hospital
- Study start
- Sep 2015
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 18 Jul 2016 (estimated)
- 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.
Medical alert devices with automatic fall detection functionality use accelerometry to detect a fall and can signal for help if the wearer forgets to, or is incapable of, pressing the alert button. This can save lives and prevent complications associated with long periods of time spent on the floor after a fall. In this project, the sensitivity and false alarm rate of a commercially available medical alert device will be tested in a population of 200 community-dwelling older adults.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary | – | Other: Fall DetectionOlder adult study participants will be recruited from the cohort of participants in the STRIDE Study at the Boston trial site (http://www.stride-study.org/). |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Older adult study participants will be recruited from the cohort of participants in the STRIDE Study at the Boston trial site (http://www.stride-study.org/).
Key inclusion criteria (1 listed)
- Enrolled in the STRIDE Study at the Boston trial site (http://www.stride-study.org/).
Key exclusion criteria (1 listed)
- Uses a medical alert device
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 |
|---|---|---|
| Fall DetectionAlso: ActivePERSAll participants will wear a device configured to detect falls. | Other | Primary |
Primary outcome
The sensitivity and specificity of ActivePERS fall detection algorithms will be measured by comparing the occurence of falls detected by the wearable device to study participant self reported falls
Time frame: 2 years
1 secondary outcome
Near falls as measured by patient self report
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- 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.
Shalendar Bhasin, MD principal investigator
Brigham and Women's Hospital
Joseph T Gwin, PhD principal investigator
BioSensics
Paolo Bonato, PhD principal investigator
Spaulding Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Falls, run by BioSensics 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 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: finished, as of the sponsor's last update on 24 Jul 2018. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The sensitivity and specificity of ActivePERS fall detection algorithms will be measured by comparing the occurence of falls detected by the wearable device to study participant self reported falls (time frame: 2 years). 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 Jul 2018.