To evaluate the effectiveness of blood pressure (BP) home monitoring on the occurrence of hypertension, efficacy of BP treatment, QOL, health-related symptoms, work ability and life-style behaviour in women 40-60 yrs, after a previous PE in…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
hoge bloeddruk
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mean systolic and diastolic BP levels, prevalence of hypertension and
medication use for hypertension at baseline, during study period and after 1
year of follow-up
Secondary outcome
- QOL measures (questionnaires)
- ability to work and work-related obstacles
- cardiac/ hypertensive symptoms and well-being
- cost-effectiveness and feasibility of BP self monitoring program
Background summary
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.
Study objective
To evaluate the effectiveness of blood pressure (BP) home monitoring on the
occurrence of hypertension, efficacy of BP treatment, QOL, health-related
symptoms, work ability and life-style behaviour in women 40-60 yrs, after a
previous PE in pregnancy
Study design
Randomized, open label study to compare eHealth guided self management of BP
monitoring and lifestyle advice with *usual care*.
Intervention
eHealth guided measurements of BP at regular intervals and recurrent lifestyle
advice will be compared with *usual care*.
Study burden and risks
All participants are asked for a baseline visit and follow-up visit at 1 year.
The intervention group will be asked to measure blood pressure at home , every
month during 7 consecutive days, twice in the morning and twice in the evening.
Both participant groups will fill in a diary during 7 days a month on health
complaints.
There are no health-related risks to participate in this study.
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Geert Grooteplein 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible for participation in this study, a subject must meet all of the following 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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL59836.091.16 |