Clinical trial NCT03228082: Blood Pressure After PREeclampsia/HELLP by SELF Monitoring Study
Official title: Blood Pressure After PREeclampsia/HELLP by SELF Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preeclampsia
Cardiovascular Risk Factor
Cardiovascular Diseases
Hypertension
Keywords: Patient empowerment
Women's Health
Home Blood Pressure Monitoring
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Interreg
First posted: 2017-07-24
Enrollment: 200
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: DEVICE_FEASIBILITY

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.


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

Primary outcomes:
measure: Feasibility of HBPM after a previous preeclampsia to evaluate the prevalence of hypertension.
timeFrame: 1 year
Secondary outcomes:
measure: Blood pressure values
timeFrame: 1 year
measure: Prevalence of hypertension
timeFrame: 1 year
measure: Effect HBPM
timeFrame: 1 year
Other outcomes:
measure: Quality of Life
timeFrame: 1 year
measure: Occupational activity
timeFrame: 1 year
measure: BP patterns
timeFrame: 1 year
measure: Cardiac symptoms
timeFrame: 1 year
measure: Costs
timeFrame: 1 year
Locations:
city: Kleve
country: Germany
facility: Katholisches Karl-Leisner-Klinikum GmbH
city: Moers
country: Germany
facility: Krankenhaus Bethanien
city: Moers
country: Germany
facility: St. Josef Krankenhaus GmbH
city: Arnhem
country: Netherlands
facility: Rijnstate Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Nijmegen
country: Netherlands
facility: Canisius-Wilhelmina Ziekenhuis
Study officials:
affiliation: Radboudumc, department Cardiology
name: A.H.E.M. Maas, Prof.dr.
role: PRINCIPAL_INVESTIGATOR
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