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Completed

NCT Number: NCT03833778

Kids + Adolescents Research Learning On Tablet Teaching Aachen

The aim of this study plan is to implement a tablet quiz in the German-speaking area, in order to test the specific knowledge about chronic inflammatory intestinal diseases (CED) concerning pediatric patients in the context of an age-appropriated and interesting digital playing environment, and to process knowledge gaps at the subsequent doctor's contact. The quiz should be combined with a game and can be performed by the patients, while they wait in the ambulance for their doctor's appointment. The investigator's goals are to grasp playfully gaps in the CED knowledge regarding the patients and to use these in the following consulting hour for clarification and advice in line with a better understanding of the disease. With this, the specific knowledge, the understanding of the disease, the therapeutic adherence, and the self-efficacy should improve the self-responsible handling of the disease. In particular, the willingness of the group of older teenagers to transit into the adult medicine can be collected and processed. The investigators want to check the efficacy in a randomized, controlled study with two groups of 15 pediatric CED patients. The hypothesis is that the additional play of the tablet-CED-quiz and the individualized advice have a positive impact on the CED knowledge, the disease activity, the CED-related life quality and the willingness of teenagers for transition.

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Key information

Age range

8 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinic for Pediatrics and Youth Medicine, University Hospital of RWTH Aachen University

Aachen, North Rhine-Westphalia, 52074, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female and male children and young adults between 8-21 years
  • Diagnosis Morbus Crohn, Colitis ulcerosa or Colitis indeterminate
  • Clarification and signed Informed Consent Form
  • Patients must know how to write and read in German
  • Patients must be able to play independently on the tablet

Exclusion criteria

  • Age < 8 years or > 21 years
  • Illiteracy
  • Mental or psychomotor disability

Treatment and study plan

Intervention group

Other

The CED patients play the tablet-CED-quiz, while they wait for their doctor's appointment, so that gaps in the CED knowledge can be clarified during the doctor's consultation.

Primary outcomes

  1. knowledge test

    Time frame: 12 months

    Comparing point values of the baseline tablet quiz and final test regarding the CED knowledge

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Acronym: KARLOTTA

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 7, 2019
Registry last updated
Oct 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.