Fall PatientsADOPACNCT04787146
File Analysis of Falling Patients: Are Drugs Frequently Involved
An observational study of Fall Patients, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
The damage caused by patient falls is a major public health problem, due to the large and growing number of people concerned, the potentially serious consequences but also the financial cost generated by their care. These consequences can be physical as well as psychological. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fall Patients
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- 18 Apr 2019to 28 Feb 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From Monday to Friday, the study will be offered to patients selected consecutively and who have fallen within the previous 24 hours (between 7.55 a.m. the day before and 7.55 a.m. the next day).
Who may be able to join
- Major patient
- French-speaking patient
- Patient hospitalized within the Paris Saint-Joseph Hospital Group
- Patient who fell during hospitalization and for whom a fall report has been completed
Who cannot join
- Patients in the process of therapeutic limitation
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient objecting to participation in the study
- Patient under legal protection
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint-Joseph
Paris, Île-de-France Region, 75014
About this study
The damage caused by patient falls is a major public health problem, due to the large and growing number of people concerned, the potentially serious consequences but also the financial cost generated by their care.
These consequences can be physical as well as psychological. Fractures and pain are the first consequences that come to mind, but many others should be mentioned: post-fall syndrome, loss of autonomy or even entering an institution, fear of falling, loss of confidence in itself.
Read the detailed description
During 2018, 285 reports of falls were counted within the Paris Saint-Joseph Hospital Group (GhPSJ). Reducing these falls is one of the institutional goals. A dedicated working group has been created to put in place preventive and corrective measures.
These falls can be caused by many factors to the patient:
- Intrinsic:
- History of a fall,
- pathologies (Parkinson's or Alzheimer's disease),
- hearing and visual disturbances,
- urinary incontinence.
- extrinsic:
- Unsuitable shoes
- unsuitable habitat,
- slippery floors (eg bathroom).
Among the intrinsic factors, polypharmacy is also found. It has been established that certain drug classes are at risk of falling, in particular psychotropic drugs (benzodiazepines, hypnotics, anxiolytics, antidepressants, neuroleptics) which promote sedation and dizziness, hypoglycemic drugs which cause hypoglycaemia in diabetic patients on -treated or antihypertensive drugs causing hypotension.
It is now clearly established that drug adherence to treatment is poor in cities, giving rise to omissions but also sometimes to overconsumption of certain drugs, including psychotropic drugs.
- Conditions
- Fall Patients
- Being tested
- No intervention
- Keywords
- Drugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Once the patient is included, a drug assessment is carried out as part of the treatment and then an compliance questionnaire is submitted to him.
| Study group | Role | What they receive |
|---|---|---|
| Patients | From Monday to Friday, the study will be offered to patients selected consecutively and who have fallen within the previous 24 hours (between 7.55 a.m. the day before and 7.55 a.m. the next day).
After delivery of the written information note to the patient, the investigating physician answers the patient's questions and accepts his non-objection. The patient should be given sufficient time to think things through to make the decision to participate in the study.
Its non-opposition will be traced in the computerized medical file created on the day of its inclusion in the protocol. Each patient participating in the study retains the possibility of participating simultaneously in another research. No exclusion period is provided for in the protocol. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the prevalence of falls associated with one or more risk factors for drug iatrogenism within the Paris Saint-Joseph Hospital Group.
Percentage of falls involving one or more drugs at risk of falling
Measured: 1 week
Secondary outcomes (3)
List the drug treatments at risk taken by patients who fall
To list the drug treatments taken by the patients who fall: carrying out the patient's drug assessment
Measured: 1 week
Evaluate the relevance of drug prescriptions in patients who fall
Average number of inappropriate medication prescriptions per patient
Measured: 1 week
Evaluate the overall compliance of falling patients
Average compliance score in patients who fall
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start18 Apr 2019
- Primary completion15 Oct 2019
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall PatientsStudies 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elodie MENAGE, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787146
- Sponsor's protocol ID
- ADOPAC
- Acronym
- ADOPAC
- Status last verified
- Mar 2021
- First submitted
- 1 Mar 2021
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- File Analysis of Falling Patients: Are Drugs Frequently Involved
- ClinicalTrials.gov ID
- NCT04787146
- Acronym / sponsor ID
- ADOPAC / ADOPAC
- Conditions
- Fall Patients
- Keywords
- Drugs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 8 Mar 2021 (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.
The damage caused by patient falls is a major public health problem, due to the large and growing number of people concerned, the potentially serious consequences but also the financial cost generated by their care.
These consequences can be physical as well as psychological. Fractures and pain are the first consequences that come to mind, but many others should be mentioned: post-fall syndrome, loss of autonomy or even entering an institution, fear of falling, loss of confidence in itself.
Detailed description
During 2018, 285 reports of falls were counted within the Paris Saint-Joseph Hospital Group (GhPSJ). Reducing these falls is one of the institutional goals. A dedicated working group has been created to put in place preventive and corrective measures.
These falls can be caused by many factors to the patient:
- Intrinsic:
- History of a fall,
- pathologies (Parkinson's or Alzheimer's disease),
- hearing and visual disturbances,
- urinary incontinence.
- extrinsic:
- Unsuitable shoes
- unsuitable habitat,
- slippery floors (eg bathroom).
Among the intrinsic factors, polypharmacy is also found. It has been established that certain drug classes are at risk of falling, in particular psychotropic drugs (benzodiazepines, hypnotics, anxiolytics, antidepressants, neuroleptics) which promote sedation and dizziness, hypoglycemic drugs which cause hypoglycaemia in diabetic patients on -treated or antihypertensive drugs causing hypotension.
It is now clearly established that drug adherence to treatment is poor in cities, giving rise to omissions but also sometimes to overconsumption of certain drugs, including psychotropic drugs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: No interventionFrom Monday to Friday, the study will be offered to patients selected consecutively and who have fallen within the previous 24 hours (between 7.55 a.m. the day before and 7.55 a.m. the next day). After delivery of the written information note to the patient, the investigating physician answers the patient's questions and accepts his non-objection. The patient should be given sufficient time to think things through to make the decision to participate in the study. Its non-opposition will be traced in the computerized medical file created on the day of its inclusion in the protocol. Each patient participating in the study retains the possibility of participating simultaneously in another research. No exclusion period is provided for in the protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From Monday to Friday, the study will be offered to patients selected consecutively and who have fallen within the previous 24 hours (between 7.55 a.m. the day before and 7.55 a.m. the next day).
Key inclusion criteria (4 listed)
- Major patient
- French-speaking patient
- Patient hospitalized within the Paris Saint-Joseph Hospital Group
- Patient who fell during hospitalization and for whom a fall report has been completed
Key exclusion criteria (5 listed)
- Patients in the process of therapeutic limitation
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient objecting to participation in the study
- Patient 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 |
|---|---|---|
| No interventionOnce the patient is included, a drug assessment is carried out as part of the treatment and then an compliance questionnaire is submitted to him. | Other | Patients |
Primary outcome
To assess the prevalence of falls associated with one or more risk factors for drug iatrogenism within the Paris Saint-Joseph Hospital Group.
Time frame: 1 week
Percentage of falls involving one or more drugs at risk of falling
3 secondary outcomes
List the drug treatments at risk taken by patients who fall
Time frame: 1 week
Evaluate the relevance of drug prescriptions in patients who fall
Time frame: 1 week
Evaluate the overall compliance of falling patients
Time frame: 1 week
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 Mar 2021.
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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.
Elodie MENAGE principal investigator
Fondation Hôpital Saint-Joseph
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 Fall Patients, run by Fondation Hôpital Saint-Joseph 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 4 inclusion and 5 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 Mar 2021. 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?
To assess the prevalence of falls associated with one or more risk factors for drug iatrogenism within the Paris Saint-Joseph Hospital Group. (time frame: 1 week). 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 Mar 2021.