Preeclampsia, Cardiovascular Risk Factor, Cardiovascular Diseases, Hypertension
Conditions
Keywords
Patient empowerment, Women's Health, Home Blood Pressure Monitoring
Brief summary
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.
Interventions
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.
Sponsors
Interreg
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention 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).
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of HBPM after a previous preeclampsia to evaluate the prevalence of hypertension. | 1 year | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect HBPM | 1 year | Effect of regular self measurements on blood pressure levels at home at 1 year follow-up |
| Blood pressure values | 1 year | Mean BP values (mmHg) in both study groups at 1 year of follow-up |
| Prevalence of hypertension | 1 year | Prevalence of hypertension in both groups at 1 year of follow-up |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cardiac symptoms | 1 year | Cardiac symptoms and blood-pressure related symptoms |
| Costs | 1 year | Cost-effectiveness of BP self-management versus regular office-based visits |
| Quality of Life | 1 year | QOL measures related to blood pressure by repeated validated questionnaires |
| Occupational activity | 1 year | Questionnaires on ability to work and work-related obstacles |
| BP patterns | 1 year | Patterns of BP levels and incidence of hypertension during follow-up |
Countries
Germany, Netherlands
Outcome results
None listed