DiGA Cara Care für Reizdarm - Evaluation of a non-invasive, non-additionally burdensome, prospective, multicentered, two-armed, randomized trial with parallel group design
Organizational Data
- DRKS-ID:
- DRKS00026631
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2021-10-06
- Last update in DRKS:
- 2024-05-03
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
Brief summary in lay language
The digital health application Cara Care für Reizdarm (Cara Care for irritable bowel syndrome) is an app intended for the digital treatment of irritable bowel syndrome (IBS). The app has the goal to reduce the severity of IBS symptoms and improve quality of life (QoL). In 2020, the efficacy of the app was already analysed with the help of standardized medical questionnaires. The planned clinical study has the aim to analyse these effects in more detail. It will be evaluated whether the use of the app Cara Care für Reizdarm can lead to positive care effects for patients with IBS.
Brief summary in scientific language
Cara Care für Reizdarm is an interactive, software-based medical application, which utilizes the most recent findings from gastroenterological medicine, nutritional science, and psychological research to create a personalized digital treatment for IBS. The application of Cara Care für Reizdarm is based on anamnestic and medically validated questionnaires, which collect patient data at the beginning and in regular intervals. These data are incorporated into an algorithm which determines the content provided to the user. This study will analyze if the use of the digital health application (DiGA) Cara Care für Reizdarm has positive care effects for patients with irritable bowel syndrome (IBS). The primary study objective is the confirmation of the superiority of the application of the DiGA Cara Care für Reizdarm (intervention group) compared to the non-application of the DiGA (control group). The superiority will be evaluated by comparing the intervention and the control group with regards to a change in disease-specific symptom severity (measured via IBS-SSS).
Health condition or problem studied
- ICD10:
- K58.1 - Irritable bowel syndrome with predominant diarrhoea [IBS-D]
- ICD10:
- K58.2 - Irritable bowel syndrome with predominant constipation [IBS-C]
- ICD10:
- K58.3 - Irritable bowel syndrome with mixed bowel habits [IBS-M]
- ICD10:
- K58.8 - Other and unspecified irritable bowel syndrome
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Access to the full version of the App
- Arm 2:
- Standard of Care and no application of the App Cara Care für Reizdarm or an alternative App
Endpoints
- Primary outcome:
- 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 outcome:
- Perception of anxiety (measured using GAD-7) Perception of depressiveness (measured using PHQ-9) Data was collected using standardized health questionnaires.
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Medical center Medizinische Hochschule Brandenburg Brandenburg
- University medical center Charité Universitätsmedizin Berlin
- Doctor's practice Berlin
- Other Klinische Forschung Berlin Mitte GmbH Berlin
Recruitment period and number of participants
- Planned study start date:
- 2021-10-28
- Actual study start date:
- 2021-12-15
- Planned study completion date:
- 2024-01-29
- Actual Study Completion Date:
- 2024-02-27
- Target Sample Size:
- 374
- Final Sample Size:
- 378
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 70 Years
- Additional 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
•Age < 18 years as well as > 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
Addresses
Primary Sponsor
- Address:
- HiDoc Technologies GmbHDr. André SommerHohe Bleichen 2220354 HamburgGermany
- Telephone:
- 030 30809546
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Städtisches Klinikum Brandenburg GmbHHochschulklinikum der MHBZentrum für Innere Medizin IIUniv.-Prof. Dr. med. Stefan LüthHochstraße 2914770 Brandenburg an der HavelGermany
- Telephone:
- 03381411600
- Fax:
- 03381411609
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.klinikum-brandenburg.de/fachbereiche/zentrum-fuer-innere-medizin-ii
Contact for Public Queries
- Address:
- Städtisches Klinikum Brandenburg GmbHHochschulklinikum der MHBZentrum für Innere Medizin IIUniv.-Prof. Dr. med. Stefan LüthHochstraße 2914770 Brandenburg an der HavelGermany
- Telephone:
- 03381411600
- Fax:
- 03381411609
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.klinikum-brandenburg.de/fachbereiche/zentrum-fuer-innere-medizin-ii
Principal Investigator
- Address:
- Städtisches Klinikum Brandenburg GmbHHochschulklinikum der MHBZentrum für Innere Medizin IIUniv.-Prof. Dr. med. Stefan LüthHochstraße 2914770 Brandenburg an der HavelGermany
- Telephone:
- 03381411600
- Fax:
- 03381411609
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.klinikum-brandenburg.de/fachbereiche/zentrum-fuer-innere-medizin-ii
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- HiDoc Technologies GmbHHohe Bleichen 2220354 HamburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Medizinischen Hochschule BrandenburgFehrbelliner Straße 3816816 NeuruppinGermany
- Telephone:
- 03391 39-14663
- Fax:
- 03391 39-14669
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.mhb-fontane.de/ethikkommission.html
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-08-03
- Ethics committee number:
- E-01-20210803
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-09-30
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- The aim of the study is to obtain a permanent inclusion into the DIGA register of the BfArM, therefore the data will be forwarded to the BfArM. At the end of the study, the anonymized results might be made available in a summary of the clinical study report and publications.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry