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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03833778
Other study ID # 18-007
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 5, 2019
Est. completion date July 31, 2020

Study information

Verified date October 2022
Source RWTH Aachen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 31, 2020
Est. primary completion date July 30, 2020
Accepts healthy volunteers No
Gender All
Age group 8 Years to 21 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
intervention group
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.

Locations

Country Name City State
Germany Clinic for Pediatrics and Youth Medicine, University Hospital of RWTH Aachen University Aachen NRW

Sponsors (1)

Lead Sponsor Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary knowledge test Comparing point values of the baseline tablet quiz and final test regarding the CED knowledge 12 months