K21
Conditions
Interventions
Sponsors
HiDoc Technologies GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: -Confirmed, medically certified diagnosis according to ICD-10-GM: K21 (gastroesophageal reflux disease) -heartburn persisting or recurring for more than three months within the last six months -episodes of heartburn on at least 2 days per week in each week within the last 4 weeks before screening -Presence of esophagogastroduodenoscopy findings, not older than 3 years, to exclude higher-grade GERD (Los Angeles grade B/C/D) and severe gastrointestinal diseases such as malignant tumors, ulcers, Barrett's esophagus and esophageal varices -Presence of informed, written consent -access to a smartphone (Android version 10.0 (API 29) or iOS 17) with internet access -Willingness to use Cara Care for Reflux and Functional Dyspepsia regularly and independently for at least 12 weeks -Willingness to answer questions at four points in time within at least 12 weeks -Health insurance in Germany
Exclusion criteria
Exclusion criteria: -Pregnancy -Patients with swallowing difficulties (dysphagia), gastrointestinal bleeding, unintentional weight loss (>5% of body weight) or other symptoms that may indicate neoplastic or severe inflammatory disease within the last 12 months -Patients with a history or symptoms that may indicate Zollinger-Ellison syndrome, gastric carcinoma, past or current peptic ulcer disease, pernicious anemia, Barrett's esophagus or systemic sclerosis -Patients with known severe esophageal dysmotility, e.g. achalasia -Active or known chronic inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease) or other severe chronic bowel disease (e.g. colitis) -Patients with a history of upper gastrointestinal (GI) surgery or endoscopic procedures such as esophageal dilatation or mucosal resection -Presence of an addiction or other illness, including mental illness (e.g. dementia, i.e. F00-F07), which may not enable patients to assess the nature, scope and possible consequences of participation in the study -Not sufficient knowledge of the German language, which is necessary for participation in the survey -Past use of Cara Care for Reflux and Functional Dyspepsia or the DiGA Cara Care for Irritable Bowel Syndrome -Patients with a connection to the sponsor, the contract research organization or the study centers, e.g. close relatives of the investigators or employees
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Improvement in disease-related quality of life (measured using QOLRAD) -Reduction in the severity of GERD-associated symptoms (measured using RDQ-GERD) -Improvement in sleep quality (measured using QOLRAD) -Reduction in symptom-related activity impairment (measured using the Work Productivity and Activity Impairment Questionnaire; WPAI) -Increase in self-efficacy in coping with chronic illnesses (measured using SES6G) | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of anxiety-associated complaints (measured using Generalized Anxiety Disorder 7; GAD-7) Reduction of depression-associated symptoms (measured using the Patient Health Questionnaire-9; PHQ-9) Reduction in the frequency and dose of proton pump inhibitors taken | — |
Countries
Germany
Outcome results
None listed