Accidental FallNOCfaoNCT02995317
Who is Falling? - Fall Risk Prediction Among Community Dwelling Elderly.
An observational study of Accidental Fall, run by University College of Northern Denmark at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate if the level of physical activity, selected physical and psychological risk factors can predict risk of falling in older (≥65) community dwellers. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Fall
- What is being tested?
- Number of falls based on an one year follow-up
- How many people
- 600 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2016to Dec 2020
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: The study will be undertaken in Aalborg Municipality at different activity-centers and nursing homes in collaboration with care workers, nurses and staff at the activity centers, all employed at the Department of Elderly and Health. Furthermore the project manager arranges briefing meetings with groups of employees in order to provide clarification of the project and encourage support of the recruitment of the study-population. Participants satisfying the inclusion and exclusion criteria is contacted by the project group, to ensure that they fully understand what it takes to participate. Subsequently, an appointment for completion of the baseline data is made.
Who may be able to join
- Home dwelling
- Manage body transfer independently
- Walking ability for at least 10 meters with or without assistive devices
Who cannot join
- Progressive neurological or rheumatologically illness
- Diagnosed vestibular problems
- Experienced pain in a substantial degree, limiting or obstructing everyday living
- Known uncorrected visual or hearing problems.
- Serious difficulties in speaking, understanding or reading Danish.
- Cognitive impairment equivalent to Mini Mental State Examination < 23
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
University College of Northern Denmark
Aalborg, 9220
Bo Grarup, Lecturer, +4572690953, bog@ucn.dk
Rogerio Pessoto Hirata, PhD, +4599409838, rirata@hst.aau.dk
About this study
Official title: The ≥65 Years NOrthern Jutland Cohort of Fall Risk Assessment With Objective Measurements (the NOCfao Study)
The purpose of this study is to investigate if the level of physical activity, selected physical and psychological risk factors can predict risk of falling in older (≥65) community dwellers.
- Conditions
- Accidental Fall
- Being tested
- Number of falls based on an one year follow-up
- Keywords
- Aged, Gait, Postural Balance, Accelerometry, Physical Activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Number of falls based on an one year follow-upOther
| Study group | Role | What they receive |
|---|---|---|
| Fall accidents | Not described Receives: Other: Number of falls based on an one year follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported number of falls confirmed by monthly phone calls
Measured: One year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accidental FallStudies 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College of Northern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg Municipality, Aalborg University
- Responsible party
- Sponsor
- Investigators
- Bo Grarup, Principal investigator, University College of Northern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995317
- Sponsor's protocol ID
- FOU-UU-006
- Acronym
- NOCfao
- Status last verified
- Apr 2020
- First submitted
- 13 Dec 2016
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Villumsen M, Grarup B, Christensen SWMP, Palsson TS, Hirata RP. "Study protocol for the >/=65 years NOrthern jutland Cohort of Fall risk Assessment with Objective measurements (the NOCfao study)". BMC Geriatr. 2020 Jun 8;20(1):198. doi: 10.1186/s12877-020-01535-6.
PubMed 32513121
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ≥65 Years NOrthern Jutland Cohort of Fall Risk Assessment With Objective Measurements (the NOCfao Study)
- ClinicalTrials.gov ID
- NCT02995317
- Acronym / sponsor ID
- NOCfao / FOU-UU-006
- Conditions
- Accidental Fall
- Keywords
- Aged, Gait, Postural Balance, Accelerometry, Physical Activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University College of Northern DenmarkUniversity, hospital or other
- Collaborators
- Aalborg Municipality, Aalborg University
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 16 Dec 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.
The purpose of this study is to investigate if the level of physical activity, selected physical and psychological risk factors can predict risk of falling in older (≥65) community dwellers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fall accidents | – | Other: Number of falls based on an one year follow-up |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- The study will be undertaken in Aalborg Municipality at different activity-centers and nursing homes in collaboration with care workers, nurses and staff at the activity centers, all employed at the Department of Elderly and Health. Furthermore the project manager arranges briefing meetings with groups of employees in order to provide clarification of the project and encourage support of the recruitment of the study-population. Participants satisfying the inclusion and exclusion criteria is contacted by the project group, to ensure that they fully understand what it takes to participate. Subsequently, an appointment for completion of the baseline data is made.
Key inclusion criteria (3 listed)
- Home dwelling
- Manage body transfer independently
- Walking ability for at least 10 meters with or without assistive devices
Key exclusion criteria (6 listed)
- Progressive neurological or rheumatologically illness
- Diagnosed vestibular problems
- Experienced pain in a substantial degree, limiting or obstructing everyday living
- Known uncorrected visual or hearing problems.
- Serious difficulties in speaking, understanding or reading Danish.
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 |
|---|---|---|
| Number of falls based on an one year follow-up | Other | Fall accidents |
Primary outcome
Self-reported number of falls confirmed by monthly phone calls
Time frame: One year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Derived from this study: PubMed 32513121Villumsen M, Grarup B, Christensen SWMP, Palsson TS, Hirata RP. "Study protocol for the >/=65 years NOrthern jutland Cohort of Fall risk Assessment with Objective measurements (the NOCfao study)". BMC Geriatr. 2020 Jun 8;20(1):198. doi: 10.1186/s12877-020-01535-6.
- Individual participant dataSharing planned: Undecided
Related trials for Accidental Fall
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COMMUNITY-DWELLING OLDER ADULTS
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Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
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Association Between Intake of Psychotropic Medications and Risk of Falls in Older Adults
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Implementing Action Falls for Domiciliary Care
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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.
Bo Grarup principal investigator
University College of Northern Denmark
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 Accidental Fall, run by University College of Northern Denmark at 1 site in Denmark.
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 3 inclusion and 6 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 15 Apr 2020. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bo Grarup (+4572690953, bog@ucn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported number of falls confirmed by monthly phone calls (time frame: One year follow-up). 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 NCT02995317, 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 15 Apr 2020.