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

Primary Purpose

Preeclampsia, Cardiovascular Risk Factor, Cardiovascular Diseases

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Home Blood Pressure Monitoring (HBPM)
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

40 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Arm Type

Experimental

No Intervention

Arm Label

Home Blood Pressure Monitoring (HBPM)

Control group

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
June 15, 2017
Last Updated
October 5, 2020
Sponsor
Radboud University Medical Center
Collaborators
INTERREG V-A
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1. Study Identification

Unique Protocol Identification Number
NCT03228082
Brief Title
Blood Pressure After PREeclampsia/HELLP by SELF Monitoring Study
Acronym
BP-PRESELF
Official Title
Blood Pressure After PREeclampsia/HELLP by SELF Monitoring
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 13, 2017 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
INTERREG V-A

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia, Cardiovascular Risk Factor, Cardiovascular Diseases, Hypertension
Keywords
Patient empowerment, Women's Health, Home Blood Pressure Monitoring

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home Blood Pressure Monitoring (HBPM)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Home Blood Pressure Monitoring (HBPM)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of HBPM after a previous preeclampsia to evaluate the prevalence of hypertension.
Description
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).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Blood pressure values
Description
Mean BP values (mmHg) in both study groups at 1 year of follow-up
Time Frame
1 year
Title
Prevalence of hypertension
Description
Prevalence of hypertension in both groups at 1 year of follow-up
Time Frame
1 year
Title
Effect HBPM
Description
Effect of regular self measurements on blood pressure levels at home at 1 year follow-up
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Quality of Life
Description
QOL measures related to blood pressure by repeated validated questionnaires
Time Frame
1 year
Title
Occupational activity
Description
Questionnaires on ability to work and work-related obstacles
Time Frame
1 year
Title
BP patterns
Description
Patterns of BP levels and incidence of hypertension during follow-up
Time Frame
1 year
Title
Cardiac symptoms
Description
Cardiac symptoms and blood-pressure related symptoms
Time Frame
1 year
Title
Costs
Description
Cost-effectiveness of BP self-management versus regular office-based visits
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A.H.E.M. Maas, Prof.dr.
Organizational Affiliation
Radboudumc, department Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Katholisches Karl-Leisner-Klinikum GmbH
City
Kleve
Country
Germany
Facility Name
Krankenhaus Bethanien
City
Moers
Country
Germany
Facility Name
St. Josef Krankenhaus GmbH
City
Moers
Country
Germany
Facility Name
Rijnstate Ziekenhuis
City
Arnhem
Country
Netherlands
Facility Name
Radboudumc
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
Canisius-Wilhelmina Ziekenhuis
City
Nijmegen
ZIP/Postal Code
6532 SZ
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
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Blood Pressure After PREeclampsia/HELLP by SELF Monitoring Study

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