- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00618800
Preventing Falls Through Enhanced Pharmaceutical Care
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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North Carolina
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Chapel Hill, North Carolina, Stati Uniti, 27599-7505
- Injury Prevention Research Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Pharmacist Care
Pharmacist Intervention
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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.
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Comparatore attivo: Control
Written information only group
|
Participants receive written information about falls prevention.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Time to first fall
Lasso di tempo: One Year
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One Year
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Proportion of participants who fall
Lasso di tempo: One Year
|
One Year
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Use of high-risk medications
Lasso di tempo: One Year
|
One Year
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Susan J. Blalock, PhD, University of North Carolina, Chapel Hill
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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