Pharmaceutical Care in Ambulatory Hemodialysis Patients

May 20, 2015 updated by: Hospital Moinhos de Vento

Effectiveness of Pharmaceutical Care in Ambulatory Hemodialysis Patients: a Randomized Controlled Pilot Study

The purpose of this study is to evaluate the effectiveness of pharmaceutical care, compared to usual care, in improving medication adherence behaviour of ambulatory hemodialysis patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
        • Hospital Moinhos de Vento

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18 years or more
  • Chronic renal patients undergoing regular hemodialysis
  • Receiving their scheduled medications (at least one drug)

Exclusion Criteria:

  • Unable to answer the questionnaire or to sign the informed consent form
  • Inability to obtain prescription drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Other: Intervention
Pharmaceutical care with educational intervention provided by a pharmacist to ambulatory hemodialysis patients
Other: Pharmaceutical care
Pharmacist-provided education on medication adherence in hemodialysis patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication adherence
Time Frame: one month
High adherence according to the Brief Medication Questionnaire
one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: one month
Quality of life will be evaluated with EQ-5D questionnaire
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Moinhos de Vento

Investigators

  • Principal Investigator: Lisiane F Leal, MBA, Hospital Moinhos de Vento

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

May 19, 2015

First Submitted That Met QC Criteria

May 20, 2015

First Posted (Estimate)

May 25, 2015

Study Record Updates

Last Update Posted (Estimate)

May 25, 2015

Last Update Submitted That Met QC Criteria

May 20, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMhem-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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