Chronic Inflammatory Intestinal Diseases (CED) Clinical Trial
— KARLOTTAOfficial title:
Kids + Adolescents Research Learning On Tablet Teaching Aachen
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 |
Verified date | October 2022 |
Source | RWTH Aachen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Clinic for Pediatrics and Youth Medicine, University Hospital of RWTH Aachen University | Aachen | NRW |
Lead Sponsor | Collaborator |
---|---|
RWTH Aachen University |
Germany,
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 |