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Clinical Trials/NCT01356563
NCT01356563
Unknown
Not Applicable

Effects of Pharmacist on Medication-related Problems in Hemodialysis Patients: a Randomized,Controlled, Double-blind Study

Sin-Lau Hospital2 sites in 1 country150 target enrollmentMay 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Renal Failure Chronic Requiring Hemodialysis
Sponsor
Sin-Lau Hospital
Enrollment
150
Locations
2
Primary Endpoint
amount of unsolved medication-related problems in each group
Last Updated
14 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 2011
End Date
May 2012
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Sin-Lau Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

amount of unsolved medication-related problems in each group

Time Frame: 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.

Secondary Outcomes

  • Patient self-reported medication compliance(14 days after recruitment)
  • pharmaceutical care satisfaction(14 days after recruitment)
  • adverse events(14 days after recruitment)
  • knowledge about medication(14 days after recruitment)

Study Sites (2)

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