Blood Pressure After PREeclampsia/HELLP by SELF Monitoring Study (BP-PRESELF)
Preeclampsia, Cardiovascular Risk Factor, Cardiovascular Diseases
About this trial
This is an interventional device feasibility trial for Preeclampsia focused on measuring Patient empowerment, Women's Health, Home Blood Pressure Monitoring
Eligibility Criteria
Inclusion Criteria:
- previous preeclampsia/HELLP syndrome, defined as diastolic BP≥90 mmHg with proteinuria ≥ 0.3gram/24 h, during one or more pregnancies, more than 1 year ago.
- 'early' or 'late' PE/HELLP
- age ≥40 and ≤ 60 years
Exclusion Criteria:
- pregnant women or women wishing for future pregnancie(s)
- inability to perform self BP measurements
- not having a smartphone (Apple or Android)
- already having regular hypertension control by GP or medical specialist
- previous cardiovascular events, such as myocardial infarction , stroke, heart failure and symptomatic ischemic heart disease
Sites / Locations
- Katholisches Karl-Leisner-Klinikum GmbH
- Krankenhaus Bethanien
- St. Josef Krankenhaus GmbH
- Rijnstate Ziekenhuis
- Radboudumc
- Canisius-Wilhelmina Ziekenhuis
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Home Blood Pressure Monitoring (HBPM)
Control group
Home monitoring of blood pressure will be performed. Blood pressure measurements will be entered automatically through a smartphone application into a patient-controlled medical record ('Patients Know Best'). The data will be available to the study coordinator, who will provide patients within 1 week with feedback on the measurements. If necessary lifestyle advice will be given, in case of hypertension patients will be referred to their GP. Once monthly a questionnaire on well-being (SF-12) and symptoms will be completed. After 6 months and 1 year patients will also receive a questionnaire on feasibility and usability of the blood pressure device.
Patients in the control group will be asked to register their blood pressure if measured during a doctor's visit, and to note medication use if applicable. They will also be asked to complete a short questionnaire on well-being (SF-12) once per month, which will be evaluated at the end of the study. No interim contact with the study coordinator is scheduled.