Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00566072
First received: November 30, 2007
Last updated: December 4, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention
Cytomegalovirus Infections
Behavioral: instructions and coaching

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Influence of Intensive Education and Coaching on Compliance for Oral Ganciclovir in the Prophylaxis of CMV: an Open Randomised Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • relation between compliance of medication towards chemoprophylaxis and occurrence of CMV infection after kidney transplantation [ Time Frame: weekly follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • relation between compliance and the instructions which a patient gets about intake of medication [ Time Frame: weekly follow-up ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: May 2001
Study Completion Date: May 2003
Arms Assigned Interventions
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
No Intervention: 2

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566072

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Hoffmann-La Roche
Investigators
Principal Investigator: Isabelle Devolder, MD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: Isabelle Devolder, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00566072     History of Changes
Other Study ID Numbers: 2001/181
Study First Received: November 30, 2007
Last Updated: December 4, 2007
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:
the effect of information on compliance of medication

Additional relevant MeSH terms:
Cytomegalovirus Infections
DNA Virus Infections
Herpesviridae Infections
Virus Diseases
Ganciclovir
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014