Accidental FallsNCT03614897
Prevention of Falls in the Elderly Population
A study testing Education in people with Accidental Falls, run by The Guthrie Clinic at 1 site in United States.
Trial summary
An educational intervention will be utilized to improve care following guidelines for treating individuals at risk of falling. A survey will be administered to providers pre and post education. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Accidental Falls
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2018to 22 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary care providers in Family Medicine and Internal Medicine
Who cannot join
- Providers in outlying clinics
Trial locations and contacts
1 site in 1 country.
About this study
An educational intervention will be utilized to improve care following guidelines for treating individuals at risk of falling. A survey will be administered to providers pre and post education.
- Conditions
- Accidental Falls
- Being tested
- Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Education on guidelines for care of individuals at risk of falling
| Study group | Role | What they receive |
|---|---|---|
| Education | Experimental | Providers participating in education related to guidelines for treating patients at risk of falling Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Survey Score for Providers' Self-reported View on Vitamin Deficiency as a Cause of Falls
Absolute change in mean survey score before and after education for providers' view on vitamin D deficiency as a cause of falls. The scale is a likert scale from 1-5: 1 important, 2 somewhat important, 3 neither important nor important, 4 somewhat important, 5 unimportant.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start9 Feb 2018
- Primary completion22 Jan 2020
- Study completion22 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accidental 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Guthrie Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alicia Harbison, DO, Principal investigator, The Guthrie ClinicSheela Prabhu, MD, Principal investigator, The Guthrie Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614897
- Sponsor's protocol ID
- 1712-62
- Status last verified
- Feb 2024
- First submitted
- 30 Jul 2018
- Last updated
- 31 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harbison AJ, Prabhu S. Causation and Treatment Algorithms for Elderly Patients who have Fallen in the Twin Tiers. Cureus. 2019 Dec 30;11(12):e6513. doi: 10.7759/cureus.6513.
PubMed 32025432
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Falls in the Elderly Population
- ClinicalTrials.gov ID
- NCT03614897
- Acronym / sponsor ID
- 1712-62
- Conditions
- Accidental Falls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- The Guthrie ClinicUniversity, hospital or other
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 22 Jan 2020 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Posted 31 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An educational intervention will be utilized to improve care following guidelines for treating individuals at risk of falling. A survey will be administered to providers pre and post education.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Education | Experimental | Behavioral: EducationProviders participating in education related to guidelines for treating patients at risk of falling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary care providers in Family Medicine and Internal Medicine
Key exclusion criteria (1 listed)
- Providers in outlying clinics
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 |
|---|---|---|
| EducationEducation on guidelines for care of individuals at risk of falling | Behavioural | Education |
Primary outcome
Change in Mean Survey Score for Providers' Self-reported View on Vitamin Deficiency as a Cause of Falls
Time frame: 1year
Absolute change in mean survey score before and after education for providers' view on vitamin D deficiency as a cause of falls. The scale is a likert scale from 1-5: 1 important, 2 somewhat important, 3 neither important nor important, 4 somewhat important, 5 unimportant.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32025432Harbison AJ, Prabhu S. Causation and Treatment Algorithms for Elderly Patients who have Fallen in the Twin Tiers. Cureus. 2019 Dec 30;11(12):e6513. doi: 10.7759/cureus.6513.
- Individual participant dataSharing planned: No
Related trials for Accidental Falls
Recruiting
Decoding the Neural Mechanisms Underlying Postural Instability and Gait Dysfunction in Parkinson's Disease
Parkinson Disease, Freezing of Gait
Recruiting
Investigating the Increased Risk of Falls in Individuals With Parkinson's Disease Treated With Deep Brain Stimulation
Deep Brain Stimulation, PARKINSON DISEASE (Disorder)
Not yet recruiting
Effects of a Novel Perturbation Balance Training Program on Laboratory and Real-World Trip-Induced Losses of Balance and Falls Among Balance-Impaired Older Adults
Accidental Fall
Not yet recruiting
Evaluation of the Effectiveness of Vision Care in Preventing Falls in Hospitalized Patients
Falls, Ulcer, Pressure
Recruiting
Combined Functional Electrical and Transcranial Direct Current Stimulation for Foot Drop
Falls, Foot Drop
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.
Alicia Harbison, DO principal investigator
The Guthrie Clinic
Sheela Prabhu, MD principal investigator
The Guthrie Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Accidental Falls, run by The Guthrie Clinic 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 31 Jul 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Mean Survey Score for Providers' Self-reported View on Vitamin Deficiency as a Cause of Falls (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03614897, which also lists 1 linked publication.
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 31 Jul 2024.