Prospective, randomized, controlled, multicenter pilot study investigating the therapy of increased blood pressure with help of a digital program
Organizational Data
- DRKS-ID:
- DRKS00031923
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2023-05-17
- Last update in DRKS:
- 2024-03-20
- Registration type:
- Retrospective
Acronym/abbreviation of the study
HELP
URL of the study
No Entry
Brief summary in lay language
This pilot study investigates the management of high blood pressure with the app "Vantis | Bluthochdruck". Within the app, patients are guided to make lifestyle changes step by step to decrease their blood pressure. This applies to the areas of nutrition, exercise, medication intake, blood pressure measurement, smoking and relaxation. The study goal is to investigate whether the app usage has a positive effect on patients' blood pressure.
Brief summary in scientific language
In this prospective, randomized, controlled, multicenter pilot study with parallel group design, we investigate the effect the app "Vantis | Bluthochdruck" has on patients' blood pressure. The app strives to minimize the risk factors after the ESC-guidelines with a medical-behavioral concept. Primary outcome is a decrease in systolic blood pressure, measured in the practice after 12 weeks of treatment. Patients are randomized in a 1:1 ratio, one half receives the product "Vantis | Bluthochdruck" for 12 weeks, additionally to care as usual (intervention group), the other half receives care as usual only (control group)
Health condition or problem studied
- ICD10:
- I10 - Essential (primary) hypertension
- ICD10:
- I11 - Hypertensive heart disease
- ICD10:
- I12 - Hypertensive renal disease
- ICD10:
- I13 - Hypertensive heart and renal disease
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- intervention group: app "Vantis | Bluthochdruck" and care as usual
- Arm 2:
- control group: care as usual
Endpoints
- Primary outcome:
- - decrease of systolic blood pressure after 13 weeks in practice measurement
- Secondary outcome:
- - decrease of diastolic blood pressure (BP) for patients with diastolic BP >84mmHg at inclusion - change of resting state heart rate for patients with heart rate >50 at inclusion - change of body mass index (BMI) for patients with BMI > 25 - number of patients in target range after 13 weeks - improvement of therapy adherence, measured with the questionnaire "Selbstfürsorge des Bluthochdrucks" - increase of patient proportion with blood pressure protocol (blood pressure regularly measured and protocoled with a diary at minimum 8 of the last 14 days) - number of unplanned physician visits for cardiovascular complaints
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Control group receives no treatment
- Phase:
- IV
- Study type:
- Interventional
- Mechanism of allocation concealment:
- via eCRF system
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- blockrandomization
- Who is blinded:
-
- Investigator/therapist
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Doctor's practice Rheinland-Pfalz
- Doctor's practice Bayern
- Doctor's practice Nordrhein-Westfalen
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2023-05-09
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 100
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- - patients with increased blood pressure - patient understands the patient information and gives written consent for study participation
Exclusion Criteria
- no compatible smartphone available or lacking knowledge of smartphone usage - insufficient understanding of the offered language (German) - start of study participation in another clinical study after inclusion in the present study - participation in a lifestyle-related rehabilitation, or device-based blood pressure therapy, or such a rehabilitation/therapy has been conducted in the last 2 months - critical or unstable health status - dependency or employment relation to the sponsor or investigator - prior usage of a comparable digital therapy
Addresses
Primary Sponsor
- Address:
- Vantis GmbHDr. Maximilian RödelWidenmayerstraße 1880538 MünchenGermany
- Telephone:
- +49 (0)89 6931 44840
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.vantis-health.com
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Kardiopraxis SchirmerProf. Dr. Dr. Stephan SchirmerAm Altenhof 867655 KaiserslauternGermany
- Telephone:
- +49 (0)631 89 2990
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Vantis GmbHDr. Maximilian RödelWidenmayerstraße 1880538 MünchenGermany
- Telephone:
- +49 (0)89 6931 44840
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Kardiopraxis SchirmerProf. Dr. Dr. Stephan SchirmerAm Altenhof 867655 KaiserslauternGermany
- Telephone:
- +49 (0)631 89 2990
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Vantis GmbHWidenmayerstraße 1880538 MünchenGermany
- Telephone:
- +49 (0)89 6931 44840
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission bei der Landesärztekammer Rheinland-PfalzDeutschhausplatz 355116 MainzGermany
- Telephone:
- +49-6131-288220
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.laek-rlp.de/ausschuesse-kommissionen/ethikkommission/
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2023-02-08
- Ethics committee number:
- 2023-16949-BO
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2023-04-21
Other Address Ethics Committee
- Address:
- Ethikkommission der Ärztekammer NordrheinTersteegenstr. 940474 DüsseldorfGermany
- Telephone:
- +49-211-43021581
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.aekno.de/aerztekammer/ethik-kommission
Vote of the Ethics Committee
- Vote of the Ethics Committee
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2023-05-11
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?:
- No
- IPD Sharing Plan:
- No Entry
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