Digital preventive measures for arterial hypertension
Organizational Data
- DRKS-ID:
- DRKS00029761
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2022-07-27
- Last update in DRKS:
- 2024-02-19
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
Brief summary in lay language
Background: High blood pressure is one of the most common and significant risk factors for cardiovascular diseases with serious cardiovascular sequelae. Surveys show that about one in three adults in Germany is affected, and two-thirds of people over the age of 65. Although high blood pressure can be treated very well with lifestyle modifications and medication, many patients do not have blood pressure levels that are adjusted according to guidelines. However, significant regional differences can also be observed in Germany. Although the use of digital offerings such as online prevention courses and health apps have the potential to reduce both overall care and regional disparities, their use has not been widespread to date. Objectives: The DiPaH project aims to identify factors that promote or hinder the use and success of digital prevention measures. A special focus will be on rural regions and age-specific effects. Methodology: In the study, patients with hypertension, active users of digital prevention services, and physicians will be surveyed about their attitudes toward digital prevention measures. In addition, routine data from the health insurance company AOK Nordost will be analyzed. Impact on care: The goal is to understand which specific patient groups can be reached with digital offerings. These findings should help to further develop digital prevention services in a targeted manner and thus successfully integrate them into broad-based care. This work was supported by the Innovation Fund at the Federal Joint Committee (Grant number 01VSF21042).
Brief summary in scientific language
The aim of the DiPah project is to systematically identify the structural and individual factors that support or hinder the digital prevention of hypertension. Different stakeholder groups are explored with a specific focus on non-urban regions and age-specific aspects. The project is an exploratory cross-sectional study with a mixed-methods design (questionnaires, interviews, health insurance routine data). The objectives are implemented through surveys of patients and physicians: Module 1: patients with hypertension insured by the health insurer AOK Nordost (n = 1. 600 questionnaires, n = 30 interviews), Module 2a: users of digital prevention services of the AOK Nordost (n = 200 questionnaires, n = 20 interviews), Module 2b: users of a hypertension app (n = 200 questionnaires, n = 20 interviews), Module 3a: family physicians (n = 200 questionnaires, n = 20 interviews), Module 3b: cardiologists (n = 200 questionnaires, n = 20 interviews). Module 4 integrates the results and derives recommendations for health care. The DiPaH study contributes to a patient-oriented and needs-based improvement of prevention services in the statutory health insurance. Patients are characterized according to their prevention needs and various characteristics (including the degree of digital health literacy), which enables patient group-specific development and implementation of digital prevention services. At the same time, physicians are involved as central points of contact for their patients in order to identify information needs and barriers in practice and thus improve care processes.
Health condition or problem studied
- ICD10:
- I10-I15 - Hypertensive diseases
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Module 1: Insurance customers of the health insurance company AOK Nordost with hypertension will be surveyed once on preferences and barriers to the use of (digital) prevention measures (n = 1,600 questionnaires). Questionnaire data will be linked to routine data to analyze further health-related factors. Prior to the AOK survey, a preparatory qualitative interview study will be conducted with hypertension patients recruited through clinics and practices (n = 30).
- Arm 2:
- Module 2: Users of (digital) prevention services offered by AOK Nordost are surveyed once on their motivation to participate, the advantages and disadvantages of digital vs. analog measures, and possible barriers to the services (n = 200 questionnaires, n = 20 interviews).
- Arm 3:
- Module 2b: Users of a hypertension app will be interviewed once about their motivation to use, access routes, and barriers (n = 200 questionnaires, n = 20 interviews).
- Arm 4:
- Module 3a: Family physicians are surveyed once on their attitudes toward digital health applications, structural and individual barriers, and information needs in medical practice (n = 200 questionnaires, n = 20 interviews).
- Arm 5:
- Module 3b: Cardiologists will be interviewed once about their attitudes toward digital health applications, structural and individual barriers, and information needs in medical practice (n = 200 questionnaires, n = 20 interviews).
Endpoints
- Primary outcome:
- Outcomes: digital health literacy; attitudes toward digital prevention; use of digital prevention; guideline-adherent medication; adherence; motivation to use digital prevention; barriers to digital prevention; perceived advantages and disadvantages of digital prevention; pathways to health care
- Secondary outcome:
- Sociodemographic characteristics (age, gender, rural vs. urban residence)
Study Design
- Purpose:
- Prevention
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
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):
-
- Other AOK Nordost Berlin
- Other BNK Service München
- Doctor's practice Berlin und Brandenburg
- Other Hypertension Care Ingolstadt
- University medical center Immanuel Klinikum Bernau Herzzentrum Brandenburg Bernau bei Berlin
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2022-08-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 2510
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Module 1 Interviews: Presence of arterial hypertension, Module 1 questionnaires: presence of arterial hypertension and covered by the AOK Nordost. Module 2a: participation in a behavioral prevention course offered by AOK Nordost, Module 2b: Use of a hypertension app within the last two years, Module 3a: Current outpatient activity as a family doctor/family physician, Module 3b: Current activity as a specialist in cardiology.
Exclusion Criteria
Patients should be able to speak German and understandable oral communication should not be an obstacle. There should be no severe impairment of mental and cognitive abilities.
Addresses
Primary Sponsor
- Address:
- Medizinische Hochschule Brandenburg Campus GmbHProf. Dr. Sebastian SpethmannFehrbelliner Str. 3816816 NeuruppinGermany
- Telephone:
- +49 30 450613235
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.mhb-fontane.de/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Medizinische Hochschule Brandenburg Theodor FontaneProf. Dr. med. Sebastian SpethmannFehrbelliner Str. 3816816 NeuruppinGermany
- Telephone:
- +49 30 450613235
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.mhb-fontane.de/
Contact for Public Queries
- Address:
- Herz- und Gefäßchirurgie, Immanuel Klinikum Bernau Herzzentrum Brandenburg, Universitätsklinikum der MHBDunja BruchLadeburger Straße 1716321 Bernau bei BerlinGermany
- Telephone:
- +49 3338 69-4543
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://bernau.immanuel.de/home/
Principal Investigator
- Address:
- Medizinische Hochschule Brandenburg Theodor FontaneProf. Dr. med. Sebastian SpethmannFehrbelliner Str. 3816816 NeuruppinGermany
- Telephone:
- +49 30 450613235
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.mhb-fontane.de/
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Innovationsausschuss beim Gemeinsamen BundesausschussGutenbergstraße 1310587 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://innovationsfonds.g-ba.de/
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Medizinischen Hochschule Brandenburg (MHB) Theodor Fontane [Ethikkommission der Medizinischen Hochschule Brandenburg Theodor Fontane Fehrbelliner Straße 38 16816 Neuruppin Deutschland https://www.mhb-fontane.de/ethikkommission.html ]Fehrbelliner Str. 3816816 NeuruppinGermany
- Telephone:
- 03391 39-14980
- Fax:
- 03391 39-31009
- 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:
- 2022-06-30
- Ethics committee number:
- E-02-20220620
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-07-06
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:
- Bruch D, Muehlensiepen F, May S, Wengemuth E, Johannsen O, Reber KC, Blankenstein E-L, Fleige G, Middeke M, Albes J, Heinze M, Lehnen M and Spethmann S (2023) Digital preventive measures for arterial hypertension (DiPaH) – a mixed-methods study protocol for health services research. Front. Cardiovasc. Med. 9:1089968. doi: 10.3389/fcvm.2022.1089968
- 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