Kids + Adolescents Research Learning On Tablet Teaching Aachen

NCT03833778 | Completed

• 1 other identifier: 18-007
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Inflammatory Intestinal Diseases (CED)

Outcome Measures

Primary Outcomes (1)

• knowledge test

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

  12 months

Study Arms (2)

Intervention group

OTHER

Answering disease related questions during playing a tablet game

Other: intervention group

control group

NO INTERVENTION

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

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

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Study Officials

• Angeliki Pappa, Dr. med.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 7, 2019
• Study Start: February 5, 2019
• Primary Completion: July 30, 2020
• Study Completion: July 31, 2020
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)