FallMEDIFALLNCT05991037
Relation Between Psychoactive Drugs Overdosage and Severity of Falls in Elderly People
A study testing Blood sampling for psychoactive drugs dosage in people with Fall, run by University Hospital, Caen at 1 site in France.
Trial summary
There are many epidemiological data on the relationship between the number or nature of psychoactive medications used and the risk of falling in elderly, but very little on the relationship between the amount of psychoactive medication actually present in the blood and the severity of the fall. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Fall
- What is being tested?
- Blood sampling for psychoactive drugs dosage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 22 May 2024to 30 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patient (male, female) aged 75 and over admitted to the emergency room for a fall and for whom hospitalization (in geriatrics or not) after going to the emergency room is planned
- Patient consuming at least one psychoactive drug from the list provided in the protocol
- Patient able to move before hospitalization with or without technical assistance
- Patient who signed the consent
- Patient subject to the social security system
Who cannot join
- Patient not requiring hospitalization after going to the emergency room
- Patient having fallen for more than 12 hours before inclusion in the study (time of sampling) [risk of excessive elimination of certain drugs with short half-lives]
- Parkinsonian patient or patient who has fallen following a convulsive attack
- Patient with a life-threatening prognosis in the very short term (state of shock, palliative care planned from the emergency room)
- Patient in wheelchair or bedridden
- Adult under legal protection, guardianship, curators
- Patient not understanding the French language
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cédric Villain, PhD contact
About this study
Official title: Consequence of Plasma Concentrations of Psychoactive Drugs Located Beyond Therapeutic Ranges on Severity of Falls in Patients Over 75 Years Old
There are many epidemiological data on the relationship between the number or nature of psychoactive medications used and the risk of falling in elderly, but very little on the relationship between the amount of psychoactive medication actually present in the blood and the severity of the fall. However, the inevitable drug-drug interactions related to polypharmacy and the pharmacokinetic modifications related to old age may lead plasma overdose situations which can potentiate the risk of falls but also aggravate these consequences. The investigators therefore propose a study with the objective of verifying whether the proportion of falls with serious traumatic consequences is more frequent in patients over 75 years old, presenting plasma overdoses of psychoactive drugs (plasma concentrations higher than the usual therapeutic concentrations) in regard to those between therapeutic ranges.
The aim of this work is to verify if the falls present more severe characters when the psychoactive drug concentrations are beyond the usual therapeutic ranges.
Read the detailed description
Patients over the age of 75 with at least one psychoactive drugs in their usual treatment will be included in the study in order to assess the severity of their fall and to measure the concentrations of all psychoactive drugs identified in their blood samples.
This study must include 400 patients over the age of 75 hospitalized for a fall in geriatrics or another department after going to the emergency room.
Patients will be included in the study as soon as they go to the emergency room during which the blood samples will be taken and several data collected. The final inclusions and the consultations to collect the clinical and biological data essential to the achievement of the main and secondary objectives will then be carried out by a geriatrician in the patient's hospitalization department.
Qualitative research and plasma assays of psychoactive drugs will be carried out by liquid phase chromatography coupled with a tandem mass spectrometer.
The expected duration of the study will be 3 years.
- Conditions
- Fall
- Being tested
- Blood sampling for psychoactive drugs dosage
- Keywords
- fall, psychoactive drugs, old patients, prescription, plasmatic concentrations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampling for psychoactive drugs dosageBiological
4 blood samples for psychoactive drugs identification and dosage will be taken on arrival at the emergency room during fall management
| Study group | Role | What they receive |
|---|---|---|
| "overdosed" group | Experimental | The experimental group will be made up of falling patients recruited for whom at least one psychoactive drug has been measured in a concentration higher than the usual therapeutic ranges. Receives: Biological: Blood sampling for psychoactive drugs dosage |
| "non-overdosed" group | Other | The control group will be made up of falling patients recruited for whom none of the psychoactive drugs have been measured in supra-therapeutic concentrations (therefore concentrations measured therapeutic or infra-therapeutic) Receives: Biological: Blood sampling for psychoactive drugs dosage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the percentages of falls with serious traumatic consequences in each of the two "overdosed" and "non-overdosed" groups.
To evaluate if serious traumatic consequences are more important in the group of elderly patients with plasma overdoses of psychoactive drugs than in the "non-overdosed" group.
Measured: 3 years
Secondary outcomes (5)
Relationship between the category of severity of the fall (according to the criteria of Schwenk et al, 2012) and the interactions highlighted in the prescription
To evaluate influence of prescribed medication on the nature of the fall.
- Prescription prior to the fall will be evaluated taking into account the drug-drug interactions. This analysis will be done taking into account the number of interactions, the effect of interactions (increase, decrease or suppression of the effect), the level of recommendations (contraindication, not recommended, precaution for use, to be taken into account).
- Severity of the fall will be evaluated according to the criteria of Schwenk et al, 2012 (serious, moderate, minor or no injuries).
Measured: 3 years
Relationship between the blood concentrations of psychoactive drugs and the occurrence of confusional syndrome assessed by the Confusion Assessment Method and/or neurocognitive disorders assessed by the Mini Mental State Evaluation.
To evaluate influence of psychoactive drug overdosage on confusional and/or cognitive state
- Blood concentrations of psychoactive drugs were measured by chromatographic methods with different unit of measure (mg/l; µg/l; mmol/l).
- Confusion Assessment Method (CAM) with 3 mandatory criteria and 2 facultative criteria.
- Mini Mental State Evaluation (MMSE) with total score between 0 and 30 (0 corresponding to severe impairment and 30 to no damage.
Measured: 3 years
Relationship between drug blood concentrations and severity of the fall, various states and functions studied during the geriatric consultation (dependence, mood, nutritional state, renal and liver function, presence of drug-drug interactions).
To evaluate the influence of psychoactive drug blood concentrations on :
- severity of the fall (same criteria as in Outcome 2)
- dependence, evaluated with 2 scales: Instrumental Activities of Daily Living (IADL) scale ranging 0 (indicating complete dependence) to 8 (indicating complete autonomy) and Activities of Daily Living (ADL) scale ranging 0 (indicating complete dysautonomia) to 6 (indicating complete autonomy) ,
- mood, evaluated with Geriatric Depression Scale (GDS) ranging 0 (as normal mood) to 15 (as high likelihood of depression)
- nutritional status, evaluated with Body Mass Index (kg/m2) and albuminemia (g/L)
- renal function evaluated with Chronic Kidney Disease EPIdemiology (CKD Epi) or Modification of Diet in Renal Disease (MDRD) (ml/min/1.73m2)
- liver function, evaluated with liver enzymes measurement (alanine aminotransferase ALAT, aspartate transaminase ASAT IU/L),
- presence of drug-drug interactions (same criteria as in Outcome 2)
Measured: 3 years
Comparison between psychoactive drugs identified in the blood and expected prescriptions (entry prescription)
To evaluate the level of adequacy between the prescription (expected prescriptions, verification of misuse, compliance, etc.) and the psychoactive drugs (nature and quantity evaluated as in outcome 3) found in the blood by chromatographic method.
Measured: 3 years
Evaluation of the severity of the fall (according to the criteria of Schwenk et al, 2012) with regard to a recent modification or not of the prescription (descriptive presentation of modification of dosage, addition ore deletion)
To evaluate the influence of recent change in the prescription (taking into account any recent adjustments to it: modification of dosage, addition of prescription or deletion of prescription) on the severity of the fall (criteria of Schwenk et al, 2012: serious, moderate, minor or no injuries).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start22 May 2024
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FallStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The severity of the fall will be assessed in the 400 patients included. The groups will be defined a posteriori, according to the results obtained for the psychoactive drug dosages. Approximately 80 patients expected in the "overdosed" group matched to the same number of subjects on gender, age and cognition from the 320 subjects in the "non-overdosed" group to meet the primary objective at risk α = 5% and a power = 80%.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Véronique Lelong-Boulouard, PhD, Study director, Caen Normandie Universitary Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991037
- Sponsor's protocol ID
- 21-0177
- Acronym
- MEDIFALL
- Status last verified
- Jul 2025
- First submitted
- 23 Aug 2022
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All study data is the exclusive property of the Promoter. Any publication relating to these can only be made after validation by the Promoter and the lead methodologist.
Publications
Bloch F, Thibaud M, Dugue B, Breque C, Rigaud AS, Kemoun G. Psychotropic drugs and falls in the elderly people: updated literature review and meta-analysis. J Aging Health. 2011 Mar;23(2):329-46. doi: 10.1177/0898264310381277. Epub 2010 Oct 14.
PubMed 20947876Han JH, Chen A, Vasilevskis EE, Schnelle JF, Ely EW, Chandrasekhar R, Morrison RD, Ryan TP, Daniels JS, Sutherland JJ, Simmons SF. Supratherapeutic Psychotropic Drug Levels in the Emergency Department and Their Association with Delirium Duration: A Preliminary Study. J Am Geriatr Soc. 2019 Nov;67(11):2387-2392. doi: 10.1111/jgs.16156. Epub 2019 Sep 10.
PubMed 31503339Schwenk M, Lauenroth A, Stock C, Moreno RR, Oster P, McHugh G, Todd C, Hauer K. Definitions and methods of measuring and reporting on injurious falls in randomised controlled fall prevention trials: a systematic review. BMC Med Res Methodol. 2012 Apr 17;12:50. doi: 10.1186/1471-2288-12-50.
PubMed 22510239
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequence of Plasma Concentrations of Psychoactive Drugs Located Beyond Therapeutic Ranges on Severity of Falls in Patients Over 75 Years Old
- ClinicalTrials.gov ID
- NCT05991037
- Acronym / sponsor ID
- MEDIFALL / 21-0177
- Conditions
- Fall
- Keywords
- fall, psychoactive drugs, old patients, prescription, plasmatic concentrations
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 22 May 2024 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 14 Aug 2023 (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.
There are many epidemiological data on the relationship between the number or nature of psychoactive medications used and the risk of falling in elderly, but very little on the relationship between the amount of psychoactive medication actually present in the blood and the severity of the fall. However, the inevitable drug-drug interactions related to polypharmacy and the pharmacokinetic modifications related to old age may lead plasma overdose situations which can potentiate the risk of falls but also aggravate these consequences. The investigators therefore propose a study with the objective of verifying whether the proportion of falls with serious traumatic consequences is more frequent in patients over 75 years old, presenting plasma overdoses of psychoactive drugs (plasma concentrations higher than the usual therapeutic concentrations) in regard to those between therapeutic ranges.
The aim of this work is to verify if the falls present more severe characters when the psychoactive drug concentrations are beyond the usual therapeutic ranges.
Detailed description
Patients over the age of 75 with at least one psychoactive drugs in their usual treatment will be included in the study in order to assess the severity of their fall and to measure the concentrations of all psychoactive drugs identified in their blood samples.
This study must include 400 patients over the age of 75 hospitalized for a fall in geriatrics or another department after going to the emergency room.
Patients will be included in the study as soon as they go to the emergency room during which the blood samples will be taken and several data collected. The final inclusions and the consultations to collect the clinical and biological data essential to the achievement of the main and secondary objectives will then be carried out by a geriatrician in the patient's hospitalization department.
Qualitative research and plasma assays of psychoactive drugs will be carried out by liquid phase chromatography coupled with a tandem mass spectrometer.
The expected duration of the study will be 3 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The severity of the fall will be assessed in the 400 patients included. The groups will be defined a posteriori, according to the results obtained for the psychoactive drug dosages. Approximately 80 patients expected in the "overdosed" group matched to the same number of subjects on gender, age and cognition from the 320 subjects in the "non-overdosed" group to meet the primary objective at risk α = 5% and a power = 80%.
| Arm | Type | Receives |
|---|---|---|
| "overdosed" group | Experimental | Biological: Blood sampling for psychoactive drugs dosageThe experimental group will be made up of falling patients recruited for whom at least one psychoactive drug has been measured in a concentration higher than the usual therapeutic ranges. |
| "non-overdosed" group | Other | Biological: Blood sampling for psychoactive drugs dosageThe control group will be made up of falling patients recruited for whom none of the psychoactive drugs have been measured in supra-therapeutic concentrations (therefore concentrations measured therapeutic or infra-therapeutic) |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patient (male, female) aged 75 and over admitted to the emergency room for a fall and for whom hospitalization (in geriatrics or not) after going to the emergency room is planned
- Patient consuming at least one psychoactive drug from the list provided in the protocol
- Patient able to move before hospitalization with or without technical assistance
- Patient who signed the consent
- Patient subject to the social security system
Key exclusion criteria (7 listed)
- Patient not requiring hospitalization after going to the emergency room
- Patient having fallen for more than 12 hours before inclusion in the study (time of sampling) [risk of excessive elimination of certain drugs with short half-lives]
- Parkinsonian patient or patient who has fallen following a convulsive attack
- Patient with a life-threatening prognosis in the very short term (state of shock, palliative care planned from the emergency room)
- Patient in wheelchair or bedridden
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 |
|---|---|---|
| Blood sampling for psychoactive drugs dosage4 blood samples for psychoactive drugs identification and dosage will be taken on arrival at the emergency room during fall management | Biological | "non-overdosed" group, "overdosed" group |
Primary outcome
Comparison of the percentages of falls with serious traumatic consequences in each of the two "overdosed" and "non-overdosed" groups.
Time frame: 3 years
To evaluate if serious traumatic consequences are more important in the group of elderly patients with plasma overdoses of psychoactive drugs than in the "non-overdosed" group.
5 secondary outcomes
Relationship between the category of severity of the fall (according to the criteria of Schwenk et al, 2012) and the interactions highlighted in the prescription
Time frame: 3 years
Relationship between the blood concentrations of psychoactive drugs and the occurrence of confusional syndrome assessed by the Confusion Assessment Method and/or neurocognitive disorders assessed by the Mini Mental State Evaluation.
Time frame: 3 years
Relationship between drug blood concentrations and severity of the fall, various states and functions studied during the geriatric consultation (dependence, mood, nutritional state, renal and liver function, presence of drug-drug interactions).
Time frame: 3 years
Comparison between psychoactive drugs identified in the blood and expected prescriptions (entry prescription)
Time frame: 3 years
Evaluation of the severity of the fall (according to the criteria of Schwenk et al, 2012) with regard to a recent modification or not of the prescription (descriptive presentation of modification of dosage, addition ore deletion)
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Results publication: PubMed 20947876Bloch F, Thibaud M, Dugue B, Breque C, Rigaud AS, Kemoun G. Psychotropic drugs and falls in the elderly people: updated literature review and meta-analysis. J Aging Health. 2011 Mar;23(2):329-46. doi: 10.1177/0898264310381277. Epub 2010 Oct 14.
- Results publication: PubMed 31503339Han JH, Chen A, Vasilevskis EE, Schnelle JF, Ely EW, Chandrasekhar R, Morrison RD, Ryan TP, Daniels JS, Sutherland JJ, Simmons SF. Supratherapeutic Psychotropic Drug Levels in the Emergency Department and Their Association with Delirium Duration: A Preliminary Study. J Am Geriatr Soc. 2019 Nov;67(11):2387-2392. doi: 10.1111/jgs.16156. Epub 2019 Sep 10.
- Results publication: PubMed 22510239Schwenk M, Lauenroth A, Stock C, Moreno RR, Oster P, McHugh G, Todd C, Hauer K. Definitions and methods of measuring and reporting on injurious falls in randomised controlled fall prevention trials: a systematic review. BMC Med Res Methodol. 2012 Apr 17;12:50. doi: 10.1186/1471-2288-12-50.
- Individual participant dataSharing planned: No. All study data is the exclusive property of the Promoter. Any publication relating to these can only be made after validation by the Promoter and the lead methodologist.
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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.
Cédric Villain, PhD contact
Véronique Lelong-Boulouard, PhD study director
Caen Normandie Universitary Hospital Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling for psychoactive drugs dosage in people with Fall, run by University Hospital, Caen 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 25 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Véronique Lelong-Boulouard, PhD (0231063341, lelongboulouard-v@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the percentages of falls with serious traumatic consequences in each of the two "overdosed" and "non-overdosed" groups. (time frame: 3 years). 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 NCT05991037, which also lists 3 linked publications.
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 25 Jul 2025.