Blood pressure monitoring in high-risk pregnancy to improve the detection and monitoring of hypertension (the BUMP 1 and 2 trials): protocol for two linked randomised controlled trials.

INTRODUCTION: Self-monitoring of blood pressure (BP) in pregnancy could improve the detection and management of pregnancy hypertension, while also empowering and engaging women in their own care. Two linked trials aim to evaluate whether BP self-monitoring in pregnancy improves the detection of raised BP during higher risk pregnancies (BUMP 1) and whether self-monitoring reduces systolic BP during hypertensive pregnancy (BUMP 2). METHODS AND ANALYSES: Both are multicentre, non-masked, parallel group, randomised controlled trials. Participants will be randomised to self-monitoring with telemonitoring or usual care. BUMP 1 will recruit a minimum of 2262 pregnant women at higher risk of pregnancy hypertension and BUMP 2 will recruit a minimum of 512 pregnant women with either gestational or chronic hypertension. The BUMP 1 primary outcome is the time to the first recording of raised BP by a healthcare professional. The BUMP 2 primary outcome is mean systolic BP between baseline and delivery recorded by healthcare professionals. Other outcomes will include maternal and perinatal outcomes, quality of life and adverse events. An economic evaluation of BP self-monitoring in addition to usual care compared with usual care alone will be assessed across both study populations within trial and with modelling to estimate long-term cost-effectiveness. A linked process evaluation will combine quantitative and qualitative data to examine how BP self-monitoring in pregnancy is implemented and accepted in both daily life and routine clinical practice. ETHICS AND DISSEMINATION: The trials have been approved by a Research Ethics Committee (17/WM/0241) and relevant research authorities. They will be published in peer-reviewed journals and presented at national and international conferences. If shown to be effective, BP self-monitoring would be applicable to a large population of pregnant women. TRIAL REGISTRATION NUMBER: NCT03334149.

Qualitative process study to explore the perceived burdens and benefits of a digital intervention for self-managing high blood pressure in Primary Care in the UK.

OBJECTIVES: Digital interventions can change patients' experiences of managing their health, either creating additional burden or improving their experience of healthcare. This qualitative study aimed to explore perceived burdens and benefits for patients using a digital self-management intervention for reducing high blood pressure. A secondary aim was to further our understanding of how best to capture burdens and benefits when evaluating health interventions. DESIGN: Inductive qualitative process study nested in a randomised controlled trial. SETTING: Primary Care in the UK. PARTICIPANTS: 35 participants taking antihypertensive medication and with uncontrolled blood pressure at baseline participated in semistructured telephone interviews. INTERVENTION: Digital self-management intervention to support blood pressure self-monitoring and medication change when recommended by the healthcare professional. ANALYSIS: Data were analysed using inductive thematic analysis with techniques from grounded theory. RESULTS: Seven themes were developed which reflected perceived burdens and benefits of using the intervention, including worry about health, uncertainty about self-monitoring and reassurance. The analysis showed how beliefs about their condition and treatment appeared to influence participants' appraisal of the value of the intervention. This suggested that considering illness and treatment perceptions in Burden of Treatment theory could further our understanding of how individuals appraise the personal costs and benefits of self-managing their health. CONCLUSIONS: Patients' appraisal of the burden or benefit of using a complex self-management intervention seemed to be influenced by experiences within the intervention (such as perceived availability of support) and beliefs about their condition and treatment (such as perceived control and risk of side effects). Developing our ability to adequately capture these salient burdens and benefits for patients could help enhance evaluation of self-management interventions in the future. Many participants perceived important benefits from using the intervention, highlighting the need for theory to recognise that engaging in self-management can include positive as well as negative aspects. TRIAL REGISTRATION NUMBER: ISRCTN13790648; Pre-results.