NEXTGEN-BP Randomised Trial

NEXTGEN-BP: Cuffless wearable blood pressure monitoring to improve patient outcomes

Background

Uncontrolled high blood pressure (BP) or hypertension is the leading cause of death in Australia. However, only one-third of Australians with hypertension achieve optimal BP control. The key barrier is treatment inertia - hesitancy of health-care providers to initiate or intensify treatment after high BP readings. This is frequently driven by uncertainty around “true” BP due to problematic assessment of office BP readings, high variability of BP and a low number of BP measurements taken in primary care to guide decision-making.

High blood pressure is a major risk factor for stroke, cardiovascular disease and chronic kidney disease and presents a considerable health burden. One in three Australians suffer from high blood pressure and only 32% have effectively controlled blood pressure.

If all Australians currently living with high blood pressure were properly treated, as many as 83,000 lives could be saved resulting in a $91.6 billion return. However, GPs are hesitant to start or intensify blood pressure treatment after high readings in the clinic due to uncertainty about the reliability of these readings.

 

Aim

The NEXTGEN-BP trial will assess in adults with hypertension, the efficacy of a remote wearable BP-based care strategy to reduce blood pressure in primary care over 12 months, compared to usual care.

The study also aims to determine if this remote wearable BP-based care strategy:

  • is acceptable to patients and GPs,
  • is cost-effective,
  • improves medication adherence,
  • improves patient engagement,
  • is safe, compared to usual care.

 

Research Methodology

The strategy involves a TGA-approved wrist-worn device, which takes hundreds of automated BP readings. The patient’s GP is provided a single number from these readings comprising the percentage of BP readings at target levels during the previous week, accompanied by a treatment decision tool. 

Participants will be randomised to either the intervention wearable wrist monitor or the control in-clinic standard BP monitoring across general practices in Australia. All participants will be monitored for 12 months and will attend three mandatory study visits for study data collection. Intervention group participants will also attend two telehealth appointments with their GP.

 

Current Status

NEXTGEN-BP logo

Start-up activities commenced. Participant recruitment has commenced.

 

For participants of this study, please refer to the Participant Information Consent Form (PICF).

If you are a GP and are interested in participating, please refer to the trial handout.

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