Blood Pressure After PREeclampsia/HELLP by SELF Monitoring Study

Study Overview
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Brief Summary
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RATIONALE: Women with a previous history of preeclampsia (PE)/HELLP have a twofold higher risk of cardiovascular disease (CVD) and a fourfold increased risk to develop hypertension at a relative young age. In the latest 2016 ESC guidelines 'CVD prevention', previous PE has been acknowledged as a serious CVD risk factor in women. In clinical practice, however, these women are still underappreciated for their CVD risk. It has not been established yet how adequate lifelong prevention in these potentially high risk women can optimally be achieved from their childbearing years onwards. OBJECTIVE: To evaluate feasibility, usability, acceptance and potential obstacles of blood pressure (BP) home monitoring in high-risk women, aged 40-60 years, after a previous PE in pregnancy. In addition to evaluate the effectiveness of BP home monitoring on the occurrence of hypertension, the efficacy of BP treatment, quality of life (QOL), health-related symptoms, work ability and life-style behaviour. STUDY DESIGN: Randomized, open label feasibility study to compare eHealth guided self management of BP monitoring and lifestyle advice with 'usual care'. STUDY POPULATION: Approximately 200 women, aged ≥ 40 and ≤ 60 years, with a previous PE in pregnancy will be invited to participate (both early and late PE). Patients will be recruited from the departments of obstetrics/gynaecology in 6 centres in the Euregio Rhein-Waal and from the department of cardiology Radboudumc. INTERVENTION: eHealth guided measurements of BP at regular intervals and recurrent lifestyle advice (intervention-group) will be compared with usual care. PRIMARY OUTCOME: Feasibility, usability, acceptance and potential obstacles of BP home monitoring in high-risk women after a previous PE in pregnancy at 1 year of follow-up.

Official Title
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Blood Pressure After PREeclampsia/HELLP by SELF Monitoring

Conditions
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Preeclampsia, Cardiovascular Risk Factor, Cardiovascular Diseases, Hypertension

Intervention / Treatment
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* Device: Home Blood Pressure Monitoring (HBPM)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized at the end of the baseline visit to self-measurement of bloodpressure at home (intervention group) or usual care (control group).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home Blood Pressure Monitoring (HBPM)<br>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. | Device: Home Blood Pressure Monitoring (HBPM)<br>* Home blood pressure monitoring using the Withings Wireless BP monitor. Patients will be asked to measure their blood pressure twice daily for 7 consecutive days. This will be repeated for every month for 1 year.<br>|
| No Intervention: Control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of HBPM after a previous preeclampsia to evaluate the prevalence of hypertension. | To evaluate feasibility of blood pressure home monitoring to diagnose hypertension at 1 year follow-up, in high-risk women with a previous preeclampsia. Feasibility will be measured using questionnaires (Likert scales). | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure values | Mean BP values (mmHg) in both study groups at 1 year of follow-up | 1 year | 
| Prevalence of hypertension | Prevalence of hypertension in both groups at 1 year of follow-up | 1 year | 
| Effect HBPM | Effect of regular self measurements on blood pressure levels at home at 1 year follow-up | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient empowerment, Women's Health, Home Blood Pressure Monitoring