Self-management of blood pressure following a hypertensive pregnancy

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2024
INTERVENTION: Women recruited to the study will be randomly assigned to one of two groups: either monitoring their own blood pressure and using this to manage their blood pressure medication, or receiving the standard care that they would otherwise have. Participants allocated to the ‘self‐management’ group will use a validated monitor and titration of antihypertensive therapy guided by a specially developed digital intervention (a smartphone app), daily following discharge from hospital after birth until their blood pressure has settled, and then once a week. They will be provided with an individualised schedule via the app for gradually adjusting their medication(s) in line with their BP readings. This will be overseen, with any change approved by their own health care professionals who review the uploaded readings and respond to tele‐monitored abnormal readings in a timely fashion. All intervention participants will in addition receive usual NHS care. Participants allocated to ‘usual care’ will have their BP monitored and medication adjusted by their obstetrician, GP and midwife as normal. Randomisation will be completed by site staff on randomising software Sortition. CONDITION: Monitoring of hypertension in women following hypertensive pregnancy ; Circulatory System PRIMARY OUTCOME: Mean daytime ambulatory diastolic blood pressure measured using an ambulatory blood pressure monitor at 26 weeks. SECONDARY OUTCOME: 1. Mean daytime ambulatory systolic blood pressure measured using an ambulatory blood pressure monitor at 26 weeks; 2. Mean 24‐hour and nocturnal ambulatory blood pressure measured using an ambulatory blood pressure monitor at 26 weeks; 3. Systolic and diastolic blood pressure at follow‐up (mean of 2nd/3rd readings and mean of 2nd – 6th readings) measured in clinic or at home at baseline, 6 weeks, 12 weeks, 26 weeks and 52 weeks; 4. Maternal health‐related quality of life measured using EQ‐5D‐5L health questionnaire results at baseline, 6 weeks, 12 weeks, 26 weeks and 52 weeks; 5. Anxiety associated with self‐management of BP measured using the short‐form anxiety inventory questionnaire at baseline, 12 weeks and 52 weeks; 6. Medication adherence measured by the presence of urinary antihypertensive metabolites at 6 weeks and the Medication Adherence Rating Scale (MARS) at baseline and 6 weeks; 7. Postnatal readmissions measured using all‐cause admissions, pregnancy hypertension admissions and cardiovascular events at records review; 8. Healthcare resource use and cost analysis of key cost drivers between study arms measured using participant resource use data collection at baseline, 12 weeks, 26 weeks and 52 weeks; 9. Cost‐consequence analysis presenting costs and key outcomes in a disaggregated manner measured over the trial period ; 10. Long‐term modelled cost‐utility analysis using quality‐adjusted life years (QALYs) measured using Modelled lifetime horizon and Sensitivity analysis to judge time to benefit/harm; 11. Qualitative process evaluation measured using in‐depth semi‐structured interviews over the trial period INCLUSION CRITERIA: 1. Participant is willing and able to give informed consent for participation in the study 2. People who have recently given birth within the last 7 days 3. Aged 18 years or above 4. Participant with pregnancy hypertension including: chronic/essential hypertension (predating current pregnancy or requiring treatment before 20/40), or gestational hypertension (new‐onset hypertension from 20/40 of inde Xpregnancy) or pre‐eclampsia (hypertension (GH or with proteinuria or metabolic changes), prior to their discharge from hospital post‐delivery. 5. Participant still requiring antihypertensive medication at randomisation following delivery 6. Able and willing to comply with trial requirements 7. Willing to allow their primary and secondary healthcare teams, if appropriate, to be notified of participation in the trial 8. Access to a smartphone compatible with the app
Epistemonikos ID: 9f77086cbae54f7c5c352fac7801fc39a212cfb1
First added on: Aug 28, 2024