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

Ghent University Hospital (UZ)

Status: Completed

Conditions: Cytomegalovirus Infections

Treatments: Behavioral: instructions and coaching

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00566072

2001/181

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

1

Experimental group

Description:

instructions and coaching on the use and intake of ganciclovir

Treatment:

Behavioral: instructions and coaching

2

No Intervention group