NCT01356563

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 19, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

May 19, 2011

Status Verified

May 1, 2011

Enrollment Period

7 months

First QC Date

May 14, 2011

Last Update Submit

May 18, 2011

Conditions

Renal Failure Chronic Requiring Hemodialysis

Keywords

hemodialysispharmacistmedication-related problemscompliance

Outcome Measures

Primary Outcomes (1)

  • amount of unsolved medication-related problems in each group

    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

Secondary Outcomes (4)

  • 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 Arms (2)

clinical pharmacist intervention

EXPERIMENTAL
Behavioral: pharmaceutical care

usual care

NO INTERVENTION

Patients randomized to usual care group will receive routine review of medication by outpatient department pharmacists and nurse.

Interventions

pharmaceutical careBEHAVIORAL

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

clinical pharmacist intervention

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old hemodialysis patient taking medications prescribed by nephrologists.

You may not qualify if:

  • Patients who refused informed consent
  • Cognitive impaired
  • unable to talk or hearing disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sin-Lau hospital

Tainan, Tainan, 701, Taiwan

NOT YET RECRUITING

Tainan Sin-Lau Hospital

Tainan, Taiwan

RECRUITING

Related Publications (3)

  • 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.

    PMID: 18628366BACKGROUND

  • 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.

    PMID: 20163271BACKGROUND

  • 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.

    PMID: 10840531BACKGROUND

MeSH Terms

Conditions

Patient Compliance

Interventions

Pharmaceutical Services

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Health ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Hung-Yi Chen

    Sin-Lau Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 14, 2011

First Posted

May 19, 2011

Study Start

May 1, 2011

Primary Completion

December 1, 2011

Study Completion

May 1, 2012

Last Updated

May 19, 2011

Record last verified: 2011-05

Locations

TW(2)