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Self-monitoring to empower women to reduce the risk of hypertension later in life after a pregnancy with pre-eclampsia acronym: LifeAPP

Grant number: 18/22705-0
Support type:Regular Research Grants
Duration: May 01, 2019 - April 30, 2021
Field of knowledge:Health Sciences - Medicine
Principal Investigator:Leandro Gustavo de Oliveira
Grantee:Leandro Gustavo de Oliveira
Home Institution: Faculdade de Medicina (FMB). Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil
Assoc. researchers: Alisse Hauspurg ; James George Roberts ; Lucy Chappell ; Maria Laura Costa Do Nascimento ; Richard McManus

Abstract

Background: cardiovascular disease (CVD) is the leading cause of death in women worldwide. Several risk factors have been considered for these high rates, but one of the most recent well-established associated risk is pre-eclampsia (PE). Of particular concern in women with a history of PE is the role of the disease in the progression of cardiovascular risks to CVD. Our aims for this study are: Aim 1. Evaluate the feasibility and acceptability of a randomised trial comparing home self-blood pressure monitoring with usual care in women with preterm PE in the first year postpartum in Brazil. Aim 2. Evaluate whether women assisted with an internet-based lifestyle intervention will be motivated to reduce their risk of CVD assuming health lifestyle encouraged via an App and messages developed with this purpose. Hypothesis: we hypothesize that compared to usual care, an internet-based lifestyle intervention implemented in the immediate postpartum period and conducted along one year will motivate women with preterm PE to reduce their basal risk of CVD. Preliminary data: The recently published SNAP-HT feasibility trial undertaken by Prof. McManus's group (co-applicant for the LifeAPP) confirms that self-management of hypertension can be successfully undertaken by women requiring antihypertensive medication in the postpartum period in United Kingdom. Dr. Alisse Hauspurg (co-applicant for the LifeAPP) demonstrated that overweight and obese women with a history of hypertensive disorders of pregnancy (USA) have a high prevalence of progression to sustained chronic hypertension, even as early as one year postpartum. Study design: This is a prospective non-masked randomized controlled trial with ascertainment of outcome by automated device. Participants eligible for this study will be patients recruited in the PREPARE project, a study developed with the aim of reducing preterm deliveries among women with preterm PE. Participants randomized to the intervention group will receive instructions on how to do self-monitoring of blood pressure using a validated monitor. They will be also instructed on how to have a health lifestyle and will receive periodical orientations along one year of follow-up. Patients will be guided by a digital application based on a smartphone with a text-based system back up. Participants randomized to the control group will receive instructions based on the Brazilian health system recommendations. All patients (Intervention and control) will attend visits at 3, 6 and 12 months after delivery and respond questionnaires about BP monitoring, lifestyle and possible adverse events along the follow-up. (AU)