Investigating the efficacy, acceptability and cost-effectiveness of a novel strategy based on a wearable blood pressure (BP) monitoring device (wrist-fitbit-type) for patients with high blood pressure plus a decision support strategy for general practitioners (GPs) on medication prescription for the treatment of hypertension. The NEXTGEN-BP randomised trial.

Patients in General Practice centres across Australia that have a clinical BP of greater than or equal to 140/90 millimetres of mercury (mmHg) and taking less than two BP drugs will be invited to participate in the study either via an invitation letter sent from the participating General Practice by the Study Coordinator (SC) with a nursing background or referred by the patient’s treating General Practitioner (GP). Patients who contact the SC or their GP will be asked to attend an appointment at the participating General Practice and will be consented and then assessed by the SC. Eligible participants will be randomised to the intervention or control arm. All consented patients will undergo study assessments by the SC at the first study visit. Participants randomised to the intervention arm will receive the intervention. The intervention involves a strategy with two main components designed to address BP treatment inertia. Firstly, it includes a clinical decision-making tool based on hundreds of automated BP readings generated over time by a wrist-worn cuffless wearable BP device by the patient. The clinical decision-making tool is a single number (percentage of BPs at target) provided by the study team to the GP practice through fax or email, prior to each patient visit. Patients will have continued access to their BP values shown on their device application (App) on their smartphone which synchronises with their device, which will allow for discussion with their GP and shared decision-making. This percentage of BPs at target will serve as a trigger to guide titration for GPs, aiming to achieve greater than 90 precent of BPs at target. GPs will be provided with hard and soft copy access to the tool. They will be provided 1 hour training on using the tool by the study team upon site initiation which will occur two to four weeks prior to patient recruitment. GPs will be able to regularly liaise with the study team to clarify queries about the tool and online video will also be available for GPs to review at their own convenience. The second component of the intervention includes two mandatory remote GP telehealth consultations (video or phone) at months 1 and 2 after enrolment into the study. The duration of the telehealth consultation is at the discretion of the GP. The study will not limit this interaction between GPs and patients but anticipate that it will be approximately 15 minutes in duration. Attendance rates will be monitored by the study team via appointment checklists. At the first study visit at the General Practice, the SC will provide the wearable BP device to the trial participants who are randomised to the intervention group and they will be able to retain the device at the end of the trial. The SC will fit the patient with the device and provide instructions on how to use the device and to initialise with the device’s App on their mobile phone. Participants will be required to wear the device day and night for 12 months except when bathing, showering and swimming and at any in-person visits to the general practice as the SC taking the study measurements should not know that the patient is in the intervention arm. Every month, the device’s mobile phone App will remind participants to initialise (calibrate) their wrist-worn BP device using the device App on their mobile phone and the BP cuff provided, to ensure accurate BP measurements are taken. Participants will also be asked to charge their device every week. One week prior to the scheduled GP telehealth consultations, the study team will prompt the participant to do the initialisation so that the single BP figure can be generated to provide to their GP. The App will not provide any information to participants such as alerts to book an appointment with their GP if their BP exceeds a safe limit or similar. After 1 month and 2 months (two time points) of wearing the device, the single BP figure automatically generated by the device will be provided to the participant’s GP via fax or email by the study team. Based on this result, the GP will meet with the participant, via a telehealth appointment, to adjust the participant’s medication dose and provide an electronic script for the new dose to the patient. The GPs can use the following up-titration steps if BP at target is less than 90 percent and patient is not reporting symptoms of hypotension. If patient uses * No medication, then start monotherapy * 1 medication, add 1 medication * 2 medications, double both doses (or add 1 medication) * 3 medications, ensure at maximum dose or add spironolactone For down titration steps based on symptoms, participants will be advised by their GP to switch to another drug. The device’s App analytics will be used to analyse participant engagement with the App. The device analytics on the device dashboard monitored by the study team will be used to determine participants’ compliance with the intervention (continued use of wearable BP device). At 3 months after the first in-person study visit, participants in both arms will be asked to attend an in-person appointment with the SC at the General Practice to measure heart rate and clinic BP; complete questionnaires on medication adherence, use of health services and engagement with study; to record any changes to medications and to collect information about the device as part of safety management. At 12 months after the first in-person study visit, participants in both arms will be asked to attend an in-person appointment with the SC at the General Practice to measure the same variables collected at 3 months and also undertake some blood tests.