|- candidate number||28083|
|- NTR Number||NTR6771|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||24-okt-2017|
|- Secondary IDs||231017 Faculty of Health, Medicine and Life Sciences, Maastricht University|
|- Public Title||Organ donation education for lower-educated adolescents|
|- Scientific Title||A web-based education program to stimulate organ donation registration among lower-educated adolescents in the Netherlands: a study protocol for a Cluster Randomized Controlled Trial |
|- hypothesis||This study is designed to give insight into the effects of an educational program about organ donation on lower-educated adolescents and how these effects were achieved. |
We expect participants to have a higher intention to register after receiving the program.
|- Healt Condition(s) or Problem(s) studied||Organ donation, Lower-educated adolescents|
|- Inclusion criteria||Adolescents in Intermediate Vocational Education (IVE) schools in The Netherlands. |
Typically students aged 16 till early 20s, but students from older ages are also included.
Participants are recruited via their schools, so no additional criteria are set on the individual level.
On class level, only classes with IVE level 2-4 are included.
|- Exclusion criteria||IVE level 1 |
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2017|
|- planned closingdate||1-mei-2018|
|- Target number of participants||1560|
|- Interventions||The experimental group will receive a web-based educational program during two 50-minute lessons in a classroom setting delivered by their own teachers. After receiving the program, they will fill in a questionnaire. |
The control group will fill in a questionnaire first and receive the educational program after.
The web-based program consists of three main elements; video fragments followed by group discussions, quizzes with tailored feedback and practicing filling in an organ donation registration form. These elements will be provided to the students during two 50-minute-lessons at school. At the end of the program, students are expected to be able to make a well-informed decision about organ donation registration and will be stimulated to register this choice.
Lesson 1 consists of four video fragments followed by group discussions. Each video deals with a concept regarding organ donation and –registration in which both positive and negative outcome expectations were included. The videos were designed to elicit discussion among students about brain death, the possibility to help other people by donating your organs, discussing the subject with others and the importance of registering in general (from the perspective of medical professionals and family members) . Teachers will be provided with a manual to facilitate discussion after each video in which students get the opportunity to share their opinions and beliefs. This activity aims to increase involvement, encourage positive beliefs and counterbalance negative beliefs.
Lesson 2 combines two program elements. First, students will individually work with the website. The website provides the participants with two quizzes. One quiz will mainly focus on testing students’ knowledge, while the other one will focus on their opinion. Each question will be followed by tailored feedback. Participants will receive information that is personally relevant and fits their needs. The main goal of the exercise is to teach participants about organ donation and –registration and give them tailored feedback on misconceptions they might have. The second part of the lesson will be spent on practicing with filling in an organ donation registration form in order to enhance self-efficacy. Students will be provided with a copy of an organ donation registration form or use a digital version. The aim is to give students an enactive mastery experience, which increases their self-efficacy and therefore increases the intention to fill in a real organ donation registration form.
|- Primary outcome||Intention to register |
|- Secondary outcome||Intention to register as a donor (with or without restrictions)|
Registration as a donor
|- Timepoints||The experimental group will fill in a questionnaire right after receiving the intervention.|
The control group will fill in the questionnaire before the intervention.
After a period of 6 months, the outcome measurements registration and registration as a donor will be measured again my means of a short questionnaire.
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Esther Steenaart|
|- CONTACT for SCIENTIFIC QUERIES|| Esther Steenaart|
|- Sponsor/Initiator ||Maastricht University, Department of Health Promotion|
(Source(s) of Monetary or Material Support)
|John William Joseph & Lenore Kirschweng Ackermans Foundation|
|- Brief summary||An educational program about organ donation will be delivered by teachers at Intermediate Vocational Education schools in the Netherlands. The effectiveness will be assessed in a two-group posttest-only randomized design be means of self-administrated questionnaires. Randomization will take place on class level. Each experimental class will be matched with a control class within the same school to optimize equivalence of groups. Both groups will receive the program. Students in the control group will fill in the questionnaire before receiving the program, while the experimental group will do this after. The questionnaire assesses demographics, behavioral determinants (attitude, self-efficacy, knowledge and social outcomes), intention to register (as a donor) and current registration status. Intention to register is the main outcome. Six months after delivery, the registration status will be assessed again.|
Participants will only be recruited in the Netherlands
|- Main changes (audit trail)|
|- RECORD||24-okt-2017 - 5-nov-2017|