Knowledge, Attitudes, PracticeEpic-SaPENCT03132857
The State of Play in Picardy of the Knowledge of the Elderly at Risk of Falling at Home in Terms of Prevention and Evaluation.
An observational study of Knowledge, Attitudes, Practice and Elderly, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
In 2010, the French population over 75 years of age was 9%; It will be 13% in 2030 and 19% in 2050 according to estimates. The incidence of falls is high in the elderly population, with at least one fall per year for one-third of the over-65s and for half of the over-80s. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Knowledge, Attitudes, Practice, Elderly
- What is being tested?
- Assess the state of knowledge of the subjects falling or at risk, their risk of recurrence or first episode, compared to medical knowledge.
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 12 Mar 2017to 16 Dec 2017
- 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
- No healthy volunteers
- Older adult
Study population: Elderly Picard subjects, living at home in fall risk factor and assessing their own risk of falling.
Who may be able to join
- male or female over 75
- considered by their attending physician as a fall arrester or at risk of falling and living at home
- presenting themselves to the office of their attending physician for a consultation for whatever reason.
Who cannot join
- EHPAD resident
- patient not affiliated to a social security scheme
- under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
In 2010, the French population over 75 years of age was 9%; It will be 13% in 2030 and 19% in 2050 according to estimates. The incidence of falls is high in the elderly population, with at least one fall per year for one-third of the over-65s and for half of the over-80s. These data are consistent with the international medical literature, particularly in Japan, the United States and France, with a high rate of recurrence from the first fall. Falling is a complex phenomenon that is of great importance in terms of morbidity and mortality since it can be followed by serious complications: failure to recover, recurrences, trauma (fractures, hematomas, wounds), complications of decubitus and ulcers, Immobilization, loss of autonomy, hospitalization, institutionalization, psychological complications (post-fall syndrome, depressive syndrome), death.
Fall risk factors are well known and described and relayed by learned societies of geriatrics and medical literature. In addition, HAS reported on this issue in 2009.
Read more
The French Society of Geriatrics and Gerontology (SFGG) defines fragility as a clinical syndrome that reflects a decrease in reserve physiological capacities that alters the coping mechanisms of stress. Its clinical expression is modulated by comorbidities and psychological, social, economic and behavioral factors. Frailty syndrome is a risk marker for mortality and pejorative events, including disability, falls, hospitalization and institutionalization. The fall and its complications are closely related to the fragility syndrome. The very fragile patient must take an active part in his own care. He is the first advocate of fall prevention.
On the other hand medical desertification and the low number of geriatricians makes this implication problematic even more so if the person is isolated or has cognitive impairment. Nevertheless, it is important to make the patient actor of his own prevention. This is the first study to describe the knowledge of older adults about their own risk of falling.
- Conditions
- Knowledge, Attitudes, Practice, Elderly
- Being tested
- Assess the state of knowledge of the subjects falling or at risk, their risk of recurrence or first episode, compared to medical knowledge.
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assess the state of knowledge of the subjects falling or at risk, their risk of recurrence or first episode, compared to medical knowledge.Other
Assess the state of knowledge of the subjects falling or at risk, their risk of recurrence or first episode, compared to medical knowledge.
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of a closed-response questionnaire on the risk of falling older adults.
Questionnaire with closed answers, based on the recommendations of the HAS (high authority of health) 2009 and the recommendations of the SFGG (French Society of Geriatrics and Gerontology) concerning the risk of fall of the elderly subject.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start12 Mar 2017
- Primary completion16 Dec 2017
- Study completion16 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132857
- Sponsor's protocol ID
- RNI2016-39 Dr Moyet
- Acronym
- Epic-SaPE
- Status last verified
- Aug 2018
- First submitted
- 14 Apr 2017
- Last updated
- 8 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The State of Play in Picardy of the Knowledge of the Elderly at Risk of Falling at Home in Terms of Prevention and Evaluation.
- ClinicalTrials.gov ID
- NCT03132857
- Acronym / sponsor ID
- Epic-SaPE / RNI2016-39 Dr Moyet
- Conditions
- Knowledge, Attitudes, Practice, Elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 12 Mar 2017 (actual)
- Primary completion
- 16 Dec 2017 (actual)
- Study completion
- 16 Dec 2017 (actual)
- First posted
- 28 Apr 2017 (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.
In 2010, the French population over 75 years of age was 9%; It will be 13% in 2030 and 19% in 2050 according to estimates. The incidence of falls is high in the elderly population, with at least one fall per year for one-third of the over-65s and for half of the over-80s. These data are consistent with the international medical literature, particularly in Japan, the United States and France, with a high rate of recurrence from the first fall. Falling is a complex phenomenon that is of great importance in terms of morbidity and mortality since it can be followed by serious complications: failure to recover, recurrences, trauma (fractures, hematomas, wounds), complications of decubitus and ulcers, Immobilization, loss of autonomy, hospitalization, institutionalization, psychological complications (post-fall syndrome, depressive syndrome), death.
Fall risk factors are well known and described and relayed by learned societies of geriatrics and medical literature. In addition, HAS reported on this issue in 2009.
The French Society of Geriatrics and Gerontology (SFGG) defines fragility as a clinical syndrome that reflects a decrease in reserve physiological capacities that alters the coping mechanisms of stress. Its clinical expression is modulated by comorbidities and psychological, social, economic and behavioral factors. Frailty syndrome is a risk marker for mortality and pejorative events, including disability, falls, hospitalization and institutionalization. The fall and its complications are closely related to the fragility syndrome. The very fragile patient must take an active part in his own care. He is the first advocate of fall prevention.
On the other hand medical desertification and the low number of geriatricians makes this implication problematic even more so if the person is isolated or has cognitive impairment. Nevertheless, it is important to make the patient actor of his own prevention. This is the first study to describe the knowledge of older adults about their own risk of falling.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly Picard subjects, living at home in fall risk factor and assessing their own risk of falling.
Key inclusion criteria (3 listed)
- male or female over 75
- considered by their attending physician as a fall arrester or at risk of falling and living at home
- presenting themselves to the office of their attending physician for a consultation for whatever reason.
Key exclusion criteria (3 listed)
- EHPAD resident
- patient not affiliated to a social security scheme
- under legal protection
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 |
|---|---|---|
| Assess the state of knowledge of the subjects falling or at risk, their risk of recurrence or first episode, compared to medical knowledge.Assess the state of knowledge of the subjects falling or at risk, their risk of recurrence or first episode, compared to medical knowledge. | Other | – |
Primary outcome
Analysis of a closed-response questionnaire on the risk of falling older adults.
Time frame: 1 day
Questionnaire with closed answers, based on the recommendations of the HAS (high authority of health) 2009 and the recommendations of the SFGG (French Society of Geriatrics and Gerontology) concerning the risk of fall of the elderly subject.
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 8 Aug 2018.
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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.
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 Knowledge, Attitudes, Practice and Elderly, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 3 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 8 Aug 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 France. 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?
Analysis of a closed-response questionnaire on the risk of falling older adults. (time frame: 1 day). 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 8 Aug 2018.