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.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Myrthe van der Zanden, MSc, Drs
- Numero di telefono: +31650094899
- Email: m.vanderzanden@erasmusmc.nl
Luoghi di studio
-
-
-
Rotterdam, Olanda, 3015GD
- Erasmus Medical Center
-
Contatto:
- Myrthe van der Zanden, MSc, Drs.
- Numero di telefono: +31650094899
- Email: m.vanderzanden@erasmusmc.nl
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Nessun intervento: Verbal instruction
Patients receive the verbal instruction about medication training from the nurses.
|
|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Incidence and type of medication errors during admission
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Patient characteristics
Lasso di tempo: 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
Lasso di tempo: At the end of admission
|
Structured questionnaire with the following questions:
|
At the end of admission
|
|
BAASIS
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Jacqueline van de Wetering, MD, Dr., Erasmus Medical Center
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 14372
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .