- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01356563
Efficacy Study of Pharmacist Intervention on Medication-related Problems in Hemodialysis Patients
Effects of Pharmacist on Medication-related Problems in Hemodialysis Patients: a Randomized,Controlled, Double-blind Study
The investigators propose that pharmacist interventions would reduce the amount of unresolved medication-related problems in hemodialysis patients.
Condition:Hemodialysis patients
Intervention:Behavioral,Pharmacist intervention
Study Design:Randomized Allocation
Control: Active Control
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Introduction:
End stage renal disease (ESRD) incidence in Taiwan ranked first and prevalence ranked second in the world from 2002 to 2005. Several foreign researches had reported that hemodialysis (HD) patients often require 12 medications to treat 5 to 6 comorbid conditions. Besides, ESRD is a lifelong disease and rates of compliance may diminish overtime. Thus, HD patients may be at particular risk for drug related problems, durg-drug interactions and noncompliance. Our aim is to analysis the effect of pharmacist in medication-related problems in ambulatory hemodialysis patients.
Methods:
This study is a randomized double-blind, active controlled trial. The investigators will invite and communicate with HD patients to find medication -related problems. After pharmacist evaluation, pharmacist will do pharmaceutical interventions to resolve medication-related problems, drug-drug interactions etc. in experimental group. In the active control group, pharmacist in this study will not do pharmaceutical interventions. The investigators will monitor each patient in a two-week period for medication-related problems.
Our primary outcome is the amount of unresolved medication-related problems in each group after two weeks. Blind outcome assessor will evaluate the amount of unresolved medication-related problems in each case as well as compliance in these patients after two weeks.
The investigators suppose that clinical pharmaceutical intervention will reduce the amount of unresolved medication-related problem in experimental group. On the other hand, patients without clinical pharmaceutical intervention will have more unresolved medication-related problems.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Tainan, Taiwan, 701
- Non ancora reclutamento
- Sin-Lau hospital
-
Contatto:
- Hung-Yi Chen, MS
- Numero di telefono: 1040 06-2748316
- Email: lawrence_chern@yahoo.com.tw
-
Contatto:
- Li-Pin Chou, MD
- Numero di telefono: 5175 06-2748316
- Email: slh10@sinlau.org.tw
-
Investigatore principale:
- Hung-Yi Chen, MS
-
Tainan city, Taiwan
- Reclutamento
- Tainan Sin-Lau Hospital
-
Contatto:
- Hung-Yi Chen, MS
- Numero di telefono: 1040 06-2748316
- Email: lawrence_chern@yahoo.com.tw
-
Contatto:
- Li-Pin Chou, MD
- Numero di telefono: 5175 06-2748316
- Email: slh10@sinlau.org.tw
-
Investigatore principale:
- Hung-Yi Chen, MS
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 20-96 years old hemodialysis patient taking medications prescribed by nephrologists.
Exclusion Criteria:
- Patients who refused informed consent
- Cognitive impaired
- unable to talk or hearing disability
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: clinical pharmacist intervention
|
Hemodialysis patients in the intervention group will receive pharmaceutical care delivered by clinical pharmacist, which including personal interview, medication review, medication reconciliation, patient education and recommended actions
|
Nessun intervento: usual care
Patients randomized to usual care group will receive routine review of medication by outpatient department pharmacists and nurse.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
amount of unsolved medication-related problems in each group
Lasso di tempo: 14 days
|
Clinical pharmacist provide pharmaceutical care in experimental group in order to reduce medication-related problems.
With pharmaceutical care, we suppose that amount of unsolved medication-related problems will less than the control group.
|
14 days
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Patient self-reported medication compliance
Lasso di tempo: 14 days after recruitment
|
14 days after recruitment, outcome assessor will record patient self-reported medication compliance. 1 score means almost noncompliance,while 5 score means that patient takes almost every medication.
|
14 days after recruitment
|
pharmaceutical care satisfaction
Lasso di tempo: 14 days after recruitment
|
From 1 score to 5 scores, 1 score means that patient is very unsatisfied with pharmaceutical care in the past 14 days.
5 scores means that patient is very satisfied with pharmaceutical care in the past 14 days.
|
14 days after recruitment
|
adverse events
Lasso di tempo: 14 days after recruitment
|
An adverse event is any adverse change in health or side effect that occurs in a person who participates in our clinical trial while the patient is receiving the medications prescribed by physician.
|
14 days after recruitment
|
knowledge about medication
Lasso di tempo: 14 days after recruitment
|
Patient self-reported knowledge about medication.
From 1 score to 5 scores, as the score increase, it means that patients know more information about his medication.
|
14 days after recruitment
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Hung-Yi Chen, Sin-Lau hospital
Pubblicazioni e link utili
Pubblicazioni generali
- Yang WC, Hwang SJ; Taiwan Society of Nephrology. Incidence, prevalence and mortality trends of dialysis end-stage renal disease in Taiwan from 1990 to 2001: the impact of national health insurance. Nephrol Dial Transplant. 2008 Dec;23(12):3977-82. doi: 10.1093/ndt/gfn406. Epub 2008 Jul 15.
- Schmid H, Schiffl H, Lederer SR. Pharmacotherapy of end-stage renal disease. Expert Opin Pharmacother. 2010 Mar;11(4):597-613. doi: 10.1517/14656560903544494.
- Manley HJ, Bailie GR, Grabe DW. Comparing medication use in two hemodialysis units against national dialysis databases. Am J Health Syst Pharm. 2000 May 1;57(9):902-6. doi: 10.1093/ajhp/57.9.902. No abstract available.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
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
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SLH-100-05
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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