Back to resultsThe Influence of Intensive Education and Coaching on Compliance for Oral Ganciclovir in the Prophylaxis of CMV: an Open Randomised Trial
Primary Purpose
Cytomegalovirus Infections
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
instructions and coaching
Sponsored by
About this trial
This is an interventional supportive care trial for Cytomegalovirus Infections focused on measuring the effect of information on compliance of medication
Eligibility 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
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
instructions and coaching on the use and intake of ganciclovir
Outcomes
Primary Outcome Measures
relation between compliance of medication towards chemoprophylaxis and occurrence of CMV infection after kidney transplantation
Secondary Outcome Measures
relation between compliance and the instructions which a patient gets about intake of medication
Full Information
NCT ID
NCT00566072
First Posted
November 30, 2007
Last Updated
December 4, 2007
Sponsor
University Hospital, Ghent
Collaborators
Hoffmann-La Roche
1. Study Identification
Unique Protocol Identification Number
NCT00566072
Brief Title
The Influence of Intensive Education and Coaching on Compliance for Oral Ganciclovir in the Prophylaxis of CMV: an Open Randomised Trial
Official Title
The Influence of Intensive Education and Coaching on Compliance for Oral Ganciclovir in the Prophylaxis of CMV: an Open Randomised Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
May 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Ghent
Collaborators
Hoffmann-La Roche
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Infections
Keywords
the effect of information on compliance of medication
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
instructions and coaching on the use and intake of ganciclovir
Arm Title
2
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
instructions and coaching
Intervention Description
instructions and coaching or no intervention on the use and intake of ganciclovir
Primary Outcome Measure Information:
Title
relation between compliance of medication towards chemoprophylaxis and occurrence of CMV infection after kidney transplantation
Time Frame
weekly follow-up
Secondary Outcome Measure Information:
Title
relation between compliance and the instructions which a patient gets about intake of medication
Time Frame
weekly follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Devolder, MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Website University Hospital Ghent
Learn more about this trial
The Influence of Intensive Education and Coaching on Compliance for Oral Ganciclovir in the Prophylaxis of CMV: an Open Randomised Trial
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