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

NCT ID: NCT00566072

Last Updated: 2007-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-05-31

Study Completion Date

2003-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cytomegalovirus Infections

Keywords

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the effect of information on compliance of medication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

instructions and coaching on the use and intake of ganciclovir

Group Type EXPERIMENTAL

instructions and coaching

Intervention Type BEHAVIORAL

instructions and coaching or no intervention on the use and intake of ganciclovir

2

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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instructions and coaching

instructions and coaching or no intervention on the use and intake of ganciclovir

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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University Hospital Ghent

Principal Investigators

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Isabelle Devolder, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

References

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Vernooij RW, Michael M, Colombijn JM, Owers DS, Webster AC, Strippoli GF, Hodson EM. Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2025 Jan 14;1(1):CD005133. doi: 10.1002/14651858.CD005133.pub4.

Reference Type DERIVED
PMID: 39807668 (View on PubMed)

Vernooij RW, Michael M, Ladhani M, Webster AC, Strippoli GF, Craig JC, Hodson EM. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2024 May 3;5(5):CD003774. doi: 10.1002/14651858.CD003774.pub5.

Reference Type DERIVED
PMID: 38700045 (View on PubMed)

Related Links

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http://www.uzgent.be

Website University Hospital Ghent

Other Identifiers

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2001/181

Identifier Type: -

Identifier Source: org_study_id