K58.1 K58.2 K58.3 K58.8
Conditions
Interventions
Group 1: Access to the full version of the App
Group 2: Standard of Care and no application of the App Cara Care für Reizdarm or an alternative App
Sponsors
HiDoc Technologies GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: ? Medically confirmed diagnosis according to ICD-10-GM (K58.- i.e.: K58.1, K58.2, K58.3, K58.8). ? signed Informed Consent Form. ? Access to tablet/smartphone with internet access. ? Willingness to use DiGA Cara Care for IBS on a regular, independent basis for at least 12 weeks. ? Willingness to answer questions at four time points over a minimum of 12 weeks.
Exclusion criteria
Exclusion criteria: •Age 70 years •Pregnancy •Addiction or other illness, including mental illness (e.g., dementia, i.e., F00-F07), which may not enable patients to assess the nature and scope as well as possible consequences of participation in the study •Insufficient knowledge of the German language which is necessary to participate in the trial •Past use of DiGA Cara Care for irritable bowel syndrome for a period of more than 2 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The alteration of disease severity - measured by Irritable Bowel Syndrome - Severity Scoring System (IBS-SSS) in the intervention and control groups will be used as the primary endpoint. Quality of life (measured using IBS-QOL). Work and activity impairment (measured using WPAI-IBS) Health literacy (measured using HLS-EU-Q16). Data was collected using standardized health questionnaires. | — |
Secondary
| Measure | Time frame |
|---|---|
| Perception of anxiety (measured using GAD-7) Perception of depressiveness (measured using PHQ-9) Data was collected using standardized health questionnaires. | — |
Countries
Germany
Contacts
Public ContactStefan Lüth
Städtisches Klinikum Brandenburg GmbHHochschulklinikum der MHBZentrum für Innere Medizin II
Outcome results
None listed