- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00618800
Preventing Falls Through Enhanced Pharmaceutical Care
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Falls are the leading cause of both fatal and nonfatal injuries among older adults in the United States. Past research suggests that individuals taking four or more prescription medications are at increased risk for falls. CNS-active drugs (e.g., benzodiazepines), in particular, have been associated with increased risk. Research also suggests that interventions to reduce inappropriate medications can reduce the risk of falls. This finding comes primarily from multifaceted interventions, however, and the impact of medication modification, by itself, remains largely unknown.
This study is using a a randomized controlled clinical trial design to evaluate a falls prevention program targeting community-dwelling older adults through community pharmacies. The study focuses on individuals at high risk for future falls. Individuals in the intervention group receive an in-depth consultation concerning their current medications, conducted by a community pharmacist. The consultation is designed to elicit medication-related problems (e.g., orthostatic hypotension, daytime sedation). Problems identified during the consultation, and therapeutic recommendations designed to address these problems, are communicated to the prescribing physician. With physician approval, appropriate modifications are made to the patient's medication regimen. The primary study endpoints are: time to first fall and proportion of individuals who fall during the one-year follow-up period.
Two primary hypotheses will be tested.
- Compared to individuals in the control group, individuals in the intervention group will experience a 30% reduction in the hazard of falling (hazard ratio=0.70) for time to first fall following randomization.
- Compared to individuals in the control group, 25% fewer people in the intervention group will experience a fall during the one-year follow-up period.
If the intervention is effective in reducing falls, these effects should be mediated by improvements in the overall quality of medication use. Thus, we will also assess effects of the intervention on: change in the number of inappropriate medications prescribed and change in the number of CNS-active medications prescribed.
One secondary hypotheses will be tested.
1. Compared to individuals in the control group, individuals in the intervention group will experience a 40% reduction in the use of high-risk medications during the one-year follow-up period.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
North Carolina
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Chapel Hill, North Carolina, États-Unis, 27599-7505
- Injury Prevention Research Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Currently taking at least four prescription medications
- Currently taking at least one high risk medication
- At least one fall during 12 month period before study entry
- Able to speak and read English
Exclusion Criteria:
- Resident of a long-term care facility
- Cognitive impairment
- Housebound
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Pharmacist Care
Pharmacist Intervention
|
Participants receive written information about falls prevention and a personal consultation from a community pharmacist concerning their medication regimen.
The pharmacist follows up, as required, with participants' physicians to coordinate any recommended medication changes.
|
Comparateur actif: Control
Written information only group
|
Participants receive written information about falls prevention.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Time to first fall
Délai: One Year
|
One Year
|
Proportion of participants who fall
Délai: One Year
|
One Year
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Use of high-risk medications
Délai: One Year
|
One Year
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Susan J. Blalock, PhD, University of North Carolina, Chapel Hill
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
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
- 5-38047/0-401-4974
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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