Physician Optimised Post-partum Hypertension Treatment Trial : Physician Optimised Post-partum Hypertension Treatment Trial

Summary of the Design ---------------------- The trial is a single centre, single blinded (the investigators will be unaware of which group the participants are allocated to), and randomised controlled study i.e. the group participants are put is allocated by chance. The study focuses on women who develop hypertensive disorders of pregnancy, which require ongoing treatment for blood pressure after birth at the time of discharge. These women will be randomised to one of two treatment arms: either usual care by GP/mid-wife/other NHS providers, or self -management of blood pressure. Women will be recruited from the John Radcliffe Hospital and this study will investigate the effectiveness of post-partum physician assisted self-management of blood pressure vs standard care over the first 6 (up to 9) months post-partum.Trial Setting and participant profile------------------------------------ The investigators aim to recruit 200 participants, of which 100 will be randomised to the intervention arm and 100 to the control arm. The intervention arm will comprise tele-monitored (remote) home blood pressure monitoring (including periods of home 24hr blood pressure monitoring) coupled to doctors overseeing medication self-management remotely. The control arm will receive 'standard' levels of NHS care from their GP and midwives and health visitors. All participants will be recruited from the Oxford Women's Centre at the John Radcliffe Hospital, which sees approximately 25 patients per month with hypertensive pregnancies (demonstrated in a local audit).Trial participants --------------------- All participants will be females of childbearing age >18 years of age. Inclusion in the trial will require a clinician confirmed diagnosis of either gestational hypertension or pre-eclampsia as defined by NICE's latest guideline for this condition (NG 133), and the women must still require anti-hypertensive medication to control their blood pressure at the time of planned discharge.Summary of the study visits-------------------------- A flow chart of the proposed study visits can be seen in the protocol in section 9.7 and in appendix A of the protocol, which illustrates more clearly this textual description . The expected duration of participant involvement will be 6 (up to 9) months from enrolment to study completion and participants will be asked to attend four study visits after their pre-screening and enrolment: baseline, at 1 week, at 6 weeks and at 6-9 months. Although this study will only involve the four visits described above (outlined in appendix A) currently, further contact may be planned over the next 10 years to allow longitudinal follow up of this cohort. Details of the follow-up visits will be defined closer to the time and REC approval will be sought for any amendment/extension to this study to allow future contact. Additional consent will be sought from the participants to ensure they are happy to continue taking part.Details of the study visits and procedures:----------------------------------------- Both groups receive the same number of study visits, 4 visits for all participants.Visit 1 (90 minutes) will take place in the first days after giving birth whilst participants remain on the post-natal ward in the Women's centre. The team will measure blood pressure, take some simple measurements e.g. weight, waist and hip circumference and scan their hearts (using ultra-sound just like they had of their babies). The team will then review the medical notes and blood tests and provide a questionnaire about lifestyle and diet, which can be completed later to shorten the visit. At the end of visit 1 participants will either be allocated to the intervention group or the control group. If allocated to the intervention group a separate member of the team will come and provide the participant with the blood pressure monitor (an OMRON EVOLV®) used for home monitoring. This team member will register and install the app on the participant's smartphone/tablet and teach the participant how to use it. They will therefore have plenty of time to practice with it whilst still in hospital.Visits 2 and 3 (30 minutes) take place at weeks 1 and 6 weeks after discharge respectively and are to measure blood pressure, take some simple measurements e.g. waist, left arm and hip circumference, and to complete a brief questionnaire. These will be offered as a home visit, or as a visit to the Cardiovascular Clinical Research Facility (CCRF) at the John Radcliffe Hospital, depending on the women's preference, although based on prior experience it is expected most women will opt for home visits at this busy time in their lives. At the end of Visit 3 (week 6) there will be a 24 hour blood pressure monitor fitted, programmed to be silent to minimise disruption to the mum and the baby and the women will be provided with a stamped, addressed envelopes to post it back to CCRF. At the end of this visit, the team will run through the additional PIS relevant to the 4th visit again. This will allow participants to ask any questions about the longer final study visit up at the hospital, as the investigators are aware there is a lot to take in on the PIS and additional information sheet at the time of enrolment. The team will also call to discuss any further questions and plan child care for this longer visit in advance a few weeks prior to the 4th visit described below.At 6-9 months there will be a slightly longer visit to CCRF in the John Radcliffe Hospital. Visit 4 (up to 4 hours) will involve measuring blood pressure again, doing another scan of the heart by ultra-sound, doing an MRI (magnet scan) of the heart and brain, and taking a blood test. There will also be a few other simple tests (not absolutely mandatory) but which are more exploratory secondary outcome measures for the study. These include: taking photos of the blood vessels in the back of the eye (retinal imaging, like an optician does), and doing some gentle exercise on a bike (akin to walking up a hill at a fast pace) during which the heart will be scanned to assess its response to exercise.Each procedure that a participant will be asked to undergo during this study is summarised below in a little more detail: 1. Bed-side blood pressure measurement (10 minutes) Three blood pressure readings will be taken at intervals of 1 minute from the left arm using an automated blood pressure monitor (unless medical reason means the left arm cannot be used). This will require sitting at rest for 5 minutes prior to doing any measurements.2. Echocardiogram scan (15 minutes) The team will perform an ultrasound (echocardiogram/echo) of the heart. This is a safe and painless procedure that takes 15 minutes. The Participant will be asked to lie on a couch on theirleft side. A probe is placed on the chest and lubricating jelly is used so the probe makes good contact with the skin. Ultrasound waves then create images of the heart on the scanner monitor. A female sonographer/scanner will be provided wherever possible and if not available, a female chaperone will be provided.3. Vicorder® (Vascular Measures and Central Blood Pressures, 10 minutes): This involves lying flat on a cough and having two blood pressure cuffs fitted, one to the right arm and one around the right thigh. These are inflated and deflated three times at short intervals to acquire the readings. It is completely safe and painless.4. Lifestyle and physical activity questionnaire (25 minutes): The questionnaire combines validated questionnaires taken from previous studies. Information will be collected on factors that affect blood pressure including: smoking frequency, alcohol and salt intake, exercise and family history. Questionnaires can be completed either during a study visit or at a later date and posted back to the study team (prepaid envelopes will be provided).5. EQ-5D-5L Quality of Life questionnaire (5 minutes): Participants will be provided with an EQ-5D-5L questionnaire, which is a widely used and validated way of assessing quality of life at a set time-point. A trained study investigator will run through the structured questionnaire during the visit with the participant.6. MRI Heart and Brain (1 hour including break) The MRI scanner is shaped like a polo mint, the hole inside measuring about 60 centimetres wide. MRI is safe and non-invasive and does not involve any ionising radiation (x-rays). However, because they use a large magnet to work, MRI scans are not suitable for everybody. Because of this, participants will be asked pre-screening safety questions to help determine if participants are able to take part. More detail about the MRI scan is provided on the additional information sheet given to participants before the 4th study visit. This additional information sheet also provides more detail about the optional sub-study of having gadolinium given (a commonly used contrast drug for MRI) to acquire an extra few images in those women who are no longer....

Medienart:	Klinische Studie

Erscheinungsjahr:	2021
Erschienen:	2021

Enthalten in:	ClinicalTrials.gov - (2021) vom: 22. Okt. Zur Gesamtaufnahme - year:2021

Sprache:	Englisch

Links:	Volltext [kostenfrei]

Themen:	610 Eclampsia Hypertension Hypertension, Pregnancy-Induced Medical Condition: Pre-Eclampsia, Gestational Hypertension Pre-Eclampsia Recruitment Status: Active, not recruiting Study Type: Interventional

Anmerkungen:	Source: Link to the current ClinicalTrials.gov record., First posted: February 18, 2020, Last downloaded: ClinicalTrials.gov processed this data on November 01, 2021, Last updated: November 03, 2021

Study ID:	NCT04273854 273353 FS/19/7/34148
Veröffentlichungen zur Studie:

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PPN (Katalog-ID):	CTG003303942