Blood Pressure After PREeclampsia/HELLP by SELF Monitoring Study (BP-PRESELF)
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|ClinicalTrials.gov Identifier: NCT03228082|
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : July 24, 2017
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.
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.
Randomized, open label feasibility study to compare eHealth guided self management of BP monitoring and lifestyle advice with 'usual care'.
Approximately 300 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.
eHealth guided measurements of BP at regular intervals and recurrent lifestyle advice (intervention-group) will be compared with "usual care".
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.
|Condition or disease||Intervention/treatment||Phase|
|Preeclampsia Cardiovascular Risk Factor Cardiovascular Diseases Hypertension||Device: Home Blood Pressure Monitoring (HBPM)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|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).|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Blood Pressure After PREeclampsia/HELLP by SELF Monitoring|
|Actual Study Start Date :||July 13, 2017|
|Estimated Primary Completion Date :||March 31, 2019|
|Estimated Study Completion Date :||March 31, 2019|
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.
- 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).
- Blood pressure values [ Time Frame: 1 year ]Mean BP values (mmHg) in both study groups at 1 year of follow-up
- Prevalence of hypertension [ Time Frame: 1 year ]Prevalence of hypertension in both groups at 1 year of follow-up
- Effect HBPM [ Time Frame: 1 year ]Effect of regular self measurements on blood pressure levels at home at 1 year follow-up
- Quality of Life [ Time Frame: 1 year ]QOL measures related to blood pressure by repeated validated questionnaires
- Occupational activity [ Time Frame: 1 year ]Questionnaires on ability to work and work-related obstacles
- BP patterns [ Time Frame: 1 year ]Patterns of BP levels and incidence of hypertension during follow-up
- Cardiac symptoms [ Time Frame: 1 year ]Cardiac symptoms and blood-pressure related symptoms
- Costs [ Time Frame: 1 year ]Cost-effectiveness of BP self-management versus regular office-based visits
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228082
|Contact: H.E.C. Muijsers, drs.||0243094069 ext email@example.com|
|Contact: A.H.E.M. Maas, Prof.dr.||0243614533 ext firstname.lastname@example.org|
|Katholisches Karl-Leisner-Klinikum GmbH||Not yet recruiting|
|Contact: S. Heiden, dr.|
|Contact: L. Trnka, dr.|
|Contact: P. Tonnies, dr.|
|Contact: D. Brunotte, dr.|
|St. Josef Krankenhaus GmbH||Recruiting|
|Contact: J. Pagels, dr.|
|Contact: M. Saxe, dr.|
|Rijnstate Ziekenhuis||Not yet recruiting|
|Contact: K. de Boer, dr.|
|Nijmegen, Netherlands, 6500 HB|
|Contact: H.E.C. Muijsers, drs. +31243094069 email@example.com|
|Principal Investigator: A.H.E.M. Maas, Professor|
|Sub-Investigator: H.E.C. Muijsers, drs.|
|Sub-Investigator: O.W.H. van der Heijden, dr.|
|Sub-Investigator: N. Roeleveld, Professor|
|Sub-Investigator: J. Lancee|
|Canisius-Wilhelmina Ziekenhuis||Not yet recruiting|
|Nijmegen, Netherlands, 6532 SZ|
|Contact: C.D. van Bijsterveldt, dr|
|Principal Investigator:||A.H.E.M. Maas, Prof.dr.||Radboudumc, department Cardiology|