Kids + Adolescents Research Learning On Tablet Teaching Aachen (KARLOTTA)
Primary Purpose
Chronic Inflammatory Intestinal Diseases (CED)
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
intervention group
Sponsored by
About this trial
This is an interventional other trial for Chronic Inflammatory Intestinal Diseases (CED)
Eligibility Criteria
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
Sites / Locations
- Clinic for Pediatrics and Youth Medicine, University Hospital of RWTH Aachen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Intervention group
control group
Arm Description
Answering disease related questions during playing a tablet game
Outcomes
Primary Outcome Measures
knowledge test
Comparing point values of the baseline tablet quiz and final test regarding the CED knowledge
Secondary Outcome Measures
Full Information
NCT ID
NCT03833778
First Posted
February 6, 2019
Last Updated
October 25, 2022
Sponsor
RWTH Aachen University
1. Study Identification
Unique Protocol Identification Number
NCT03833778
Brief Title
Kids + Adolescents Research Learning On Tablet Teaching Aachen
Acronym
KARLOTTA
Official Title
Kids + Adolescents Research Learning On Tablet Teaching Aachen
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 5, 2019 (Actual)
Primary Completion Date
July 30, 2020 (Actual)
Study Completion Date
July 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Inflammatory Intestinal Diseases (CED)
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Other
Arm Description
Answering disease related questions during playing a tablet game
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
intervention group
Intervention Description
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 Outcome Measure Information:
Title
knowledge test
Description
Comparing point values of the baseline tablet quiz and final test regarding the CED knowledge
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angeliki Pappa, Dr. med.
Organizational Affiliation
Clinic for Pediatrics and Youth Medicine, University Hospital of RWTH Aachen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic for Pediatrics and Youth Medicine, University Hospital of RWTH Aachen University
City
Aachen
State/Province
NRW
ZIP/Postal Code
52074
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Kids + Adolescents Research Learning On Tablet Teaching Aachen
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