U09.9
Conditions
Interventions
Group 1: App-based telemonitoring for post-covid in children and adolescents. Duration of telemonitoring including app and sensors over three months, complementary between the routine initial and foll
Sponsors
AG 4 - Digitale Medizin, Medizinische Fakultät OWL, Bielefeld
Eligibility
Sex/Gender
All
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: Prerequisites for participation in the study are: - Fulfillment of the WHO diagnostic criteria for the presence of post-covoid and the Delphi consensus on research in post-covoid in children and adolescents based on these criteria. - The patient* is between 12 and 17 years old at the time of inclusion. - The patient* has access to a smartphone for personal use. This must meet the following criteria: Android operating system from version 8, or iOS operating system from version 15. - Ability to give consent and sufficient German language skills of the child/adolescent and at least one legal guardian.
Exclusion criteria
Exclusion criteria: Failure to meet any of the above inclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantitative evaluation: Conduct designated measurements and data inputs using usage data and structured questionnaires. Review at the end of the three-month study period: - Weekly average values of measured parameters (FEV1, PEF, step count, pulse, heart rate variability). - Four-weekly results of the questionnaires integrated in the app (Fatigue Severity Scale, Bell score, DSQ-PEM as screening for Post-Exertional Malaise, own screening for school attendance). - Evaluation by means of quantitative questionnaires (Technology Usage Inventory, System Usability Scale, own questionnaire adapted from similar study of our research group with adults (Covid19@Home). Qualitative evaluation: Factors influencing adherence and acceptance by children/adolescents and parents; perceived effects on the course of the disease; view of the study physicians on monitoring and integration into standard treatment. Review at the end of the three-month study period: - Semistructured interviews with child and guardian using interview guidelines based on the Technology Acceptance Model, adapted from similar study by our research group in adults (Covid19@Home). | — |
Secondary
| Measure | Time frame |
|---|---|
| Descriptive presentation of the course of lung function, resting heart rate, heart rate variability at rest and after controlled light daily activity. - Change in severity of fatigue based on questionnaires - Number of days missed from school and days with restrictions in daily life | — |
Countries
Germany
Contacts
Public ContactSebastian Kuhn
AG 4 - Digitale Medizin, Medizinische Fakultät OWL, Universität Bielefeld
Outcome results
None listed