The Influence of Intensive Education and Coaching on Compliance for Oral Ganciclovir in the Prophylaxis of CMV: an Open Randomised Trial

December 4, 2007 updated by: University Hospital, Ghent
21 patients were randomised to receive instructions and coaching or no intervention on the use and intake of ganciclovir. Intake of medication was measured by an electronic pill box. The duration of the study was 100 days.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

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 Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital Ghent

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • men and women between 18 and 65 years old
  • de novo kidney transplant patients
  • patients who need CMV prophylaxis with ganciclovir during 3 months
  • patients who gave informed consent after an oral explanation of the study

Exclusion Criteria:

  • patients who are seronegative for CMV virus and who received a kidney from a CMV negative donor
  • patients with a creatinin clearance of less than 10 ml/min

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 2
Experimental: 1
instructions and coaching on the use and intake of ganciclovir
Behavioral: instructions and coaching
instructions and coaching or no intervention on the use and intake of ganciclovir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
relation between compliance of medication towards chemoprophylaxis and occurrence of CMV infection after kidney transplantation
Time Frame: weekly follow-up
weekly follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
relation between compliance and the instructions which a patient gets about intake of medication
Time Frame: weekly follow-up
weekly follow-up

Collaborators and Investigators

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

Sponsor

University Hospital, Ghent

Collaborators

Hoffmann-La Roche

Investigators

  • Principal Investigator: Isabelle Devolder, MD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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, 2001

Study Completion (Actual)

May 1, 2003

Study Registration Dates

First Submitted

November 30, 2007

First Submitted That Met QC Criteria

November 30, 2007

First Posted (Estimate)

December 3, 2007

Study Record Updates

Last Update Posted (Estimate)

December 6, 2007

Last Update Submitted That Met QC Criteria

December 4, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2001/181

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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