- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04787146
File Analysis of Falling Patients: Are Drugs Frequently Involved (ADOPAC)
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.
Aperçu de l'étude
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Ile De France
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Paris, Ile De France, France, 75014
- Groupe Hospitalier Paris Saint-Joseph
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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. |
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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
To assess the prevalence of falls associated with one or more risk factors for drug iatrogenism within the Paris Saint-Joseph Hospital Group.
Délai: 1 week
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Percentage of falls involving one or more drugs at risk of falling
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1 week
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
List the drug treatments at risk taken by patients who fall
Délai: 1 week
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To list the drug treatments taken by the patients who fall: carrying out the patient's drug assessment
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1 week
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Evaluate the relevance of drug prescriptions in patients who fall
Délai: 1 week
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Average number of inappropriate medication prescriptions per patient
|
1 week
|
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Evaluate the overall compliance of falling patients
Délai: 1 week
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Average compliance score in patients who fall
|
1 week
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Elodie MENAGE, Groupe hospitalier Paris saint Joseph
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- ADOPAC
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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