Blood Pressure After PREeclampsia/HELLP by SELF Monitoring Study (BP-PRESELF)

October 5, 2020 updated by: Radboud University Medical Center

Blood Pressure After PREeclampsia/HELLP by SELF Monitoring

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Kleve, Germany
        • Katholisches Karl-Leisner-Klinikum GmbH
      • Moers, Germany
        • Krankenhaus Bethanien
      • Moers, Germany
        • St. Josef Krankenhaus GmbH
  • Netherlands
      • Arnhem, Netherlands
        • Rijnstate Ziekenhuis
      • Nijmegen, Netherlands, 6500 HB
        • Radboudumc
      • Nijmegen, Netherlands, 6532 SZ
        • Canisius-Wilhelmina Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Home Blood Pressure Monitoring (HBPM)

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)
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.
No Intervention: Control group
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of HBPM after a previous preeclampsia to evaluate the prevalence of hypertension.
Time Frame: 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).
1 year

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: 1 year
QOL measures related to blood pressure by repeated validated questionnaires
1 year
Occupational activity
Time Frame: 1 year
Questionnaires on ability to work and work-related obstacles
1 year
BP patterns
Time Frame: 1 year
Patterns of BP levels and incidence of hypertension during follow-up
1 year
Cardiac symptoms
Time Frame: 1 year
Cardiac symptoms and blood-pressure related symptoms
1 year
Costs
Time Frame: 1 year
Cost-effectiveness of BP self-management versus regular office-based visits
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

INTERREG V-A

Investigators

  • Principal Investigator: A.H.E.M. Maas, Prof.dr., Radboudumc, department Cardiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2017

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

June 15, 2017

First Submitted That Met QC Criteria

July 19, 2017

First Posted (Actual)

July 24, 2017

Study Record Updates

Last Update Posted (Actual)

October 6, 2020

Last Update Submitted That Met QC Criteria

October 5, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL59836.091.16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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