- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07592624
Evaluation of an Instructional Video About Medication Management During Admission and Medication Adherence for Kidney Transplantation and in the Outpatient Clinic in a Dutch University Hospital. (MediT)
The goal of this RCT is to evaluate the effect of the instructional video on improving patient compliance and reducing medication errors. The study will include adult kidney transplant recipients (18 years or older) at Erasmus MC who have undergone a kidney transplantation starting January 2026.
The main questions it aims to answer:
The primary aim of this study is to assess whether our developed video instruction, compared with the traditional verbal instruction, both of which are given shortly before training during admission, reduces the number of medication errors in kidney transplant patients.
The study will also examine the correlation between patient characteristics (such as age, comorbidities, and language proficiency) and medication errors. Additionally, patient-reported medication errors will be measured through a questionnaire completed during follow-up visits at the outpatient clinic, which is part of standard care.
The instructional video will be evaluated by a short questionnaire.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Myrthe van der Zanden, MSc, Drs
- Phone Number: +31650094899
- Email: m.vanderzanden@erasmusmc.nl
Study Locations
-
-
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Rotterdam, Netherlands, 3015GD
- Erasmus Medical Center
-
Contact:
- Myrthe van der Zanden, MSc, Drs.
- Phone Number: +31650094899
- Email: m.vanderzanden@erasmusmc.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- The patient is able to take the medication independently or with the help of someone else (professionals not included).
- After admission, the patient is discharged to their own home or home of friend/relative.
- The patient had a follow up at the outpatient clinic in the Erasmus Medical Center for at least one year after transplantation.
- The patient is able to read the medication list or an illiteracy-friendly medication list.
Exclusion Criteria:
- Patients under 18 years of age
- Patients who got discharged with a medication dispenser
- Refusal to participate in the study.
- Cognitive impairments that hinder participation.
- Patients and/or family who can not understand (language barrier) the instructional video.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Verbal instruction
Patients receive the verbal instruction about medication training from the nurses.
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|
|
Experimental: Video instruction
Patients receive the instruction video about medication training from the nurses.
|
Self developed instructional video for a Dutch university hospital, for Dutch kidney transplant patients.
Instructional video is about medication administration during admission.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence and type of medication errors during admission
Time Frame: During admission
|
The primary outcome of this study will be the incidence (number of medication errors) and type of medication errors ( 1)Medication preparation omitted, 2) Incorrect dosage, 3) Incorrect administration at the scheduled time, 4), Medication discontinued inappropriately, 5)Error not documented by the nurse) during admission, evaluated through direct observation by healthcare providers.
These errors will be documented and reported via patient portals by nurses.
|
During admission
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient characteristics
Time Frame: During admission
|
Age (in years), gender (male/female/nonbinair), country of origin, language proficiency, number of previous organ transplantations, donor type of the kidney transplant (DCD, DBD, Living), and renal replacement therapy (HD/PD/Pre-emptive).
|
During admission
|
|
Evaluation of the instructional video
Time Frame: At the end of admission
|
Structured questionnaire with the following questions:
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At the end of admission
|
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BAASIS
Time Frame: During the first year follow up at the out patient clinic after kidney transplantation in the Erasmus MC
|
Participants will complete a patient-reported questionnaire (BAASIS) every three months during the first year after transplantation. The questionnaire consists of five yes/no questions related to medication errors occurring in the home setting. The questions will ask whether the participant has:
The goal is to evaluate whether there is a reduction in home-reported medication errors for those who receive a different medication management training method in the hospital. |
During the first year follow up at the out patient clinic after kidney transplantation in the Erasmus MC
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jacqueline van de Wetering, MD, Dr., Erasmus Medical Center
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14372
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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