The goal of this clinical trial is to learn if digital care pathway (DCP) and digital non-real-time messaging, in other words, asynchronous communication (AC) with nurse works to treat high blood pressure in adults in primary care. It will also learn if DCP and AC are good value for money. The main questions it aims to answer are:
* Does DCP and AC lower systolic blood pressure? * Are DCP and AC good value for money in treating high blood pressure? Researchers will compare usual care plus DCP and usual care plus DCP with AC to usual care only to see if DCP and AC works to treat high blood pressure.
Participants will:
* Get usual care or usual care plus DCP or usual care plus DCP with AC for 6 months * Visit the study nurse at the start of the trial and after 6 months for checkup and tests which include usual laboratory tests for high blood pressure * Answer online survey questions and measure their blood pressure at home for 4 days at the start of the trial and after 6 months
a diagnosis of hypertension for at least 3 months
an office blood pressure of ≥140/90 mmHg at baseline
access to a smartphone and the ability to use strong electronic identification for application login
ability to measure home blood pressure
unwillingness to participate in the study
secondary hypertension or hypertensive crisis (office blood pressure >200/130 mmHg)
atrial fibrillation
stage 4 or 5 chronic kidney disease (eGFR <30 mL/min/1.73 m²)
Parallel
Digital care pathway for hypertension
DeviceDigital care pathway for hypertension is a web-based and mobile application that includes goal setting and education material for hypertension, entering home blood pressure values, medication list and medication intake, blood pressure self-test and self-care survey, reminders on measuring values, upcoming appointments and self-care guidance, motivational messages and diary.
Asynchronous communication with nurse
DeviceAsynchronous communication means digital bidirectional non-real-time messaging between participant and nurse. It can be used with digital care pathway.
Change from Baseline in the Office Systolic Blood Pressure Level at 6 Months
Office systolic blood pressure is measured using a validated and calibrated blood pressure monitor in accordance with the 2024 European Society of Cardiology (ESC) guidelines. Three blood pressure measurements are taken by the study nurse during the office visit, and the average of the last two measurements is used as the participant's blood pressure level. If the blood pressure readings differ by more than 10 mmHg, additional measurements are taken.
Change from Baseline in the Home Systolic Blood Pressure Level at 6 Months
Home systolic blood pressure is measured using a validated blood pressure monitor listed in the STRIDE BP database, in accordance with the Finnish Current Care Guidelines for Hypertension. Participants measure their seated cuff blood pressure twice in the morning and twice in the evening for four consecutive days. The home blood pressure level is defined as the mean of all recorded measurements.
Proportion of Participants with Controlled Blood Pressure at 6 months
Controlled blood pressure is defined as an office blood pressure level \<140/90 mmHg and a home blood pressure level \<135/85 mmHg according to the Finnish Current Care Guidelines for Hypertension
Change from Baseline in the Cardiovascular Disease Risk at 6 Months assessed by FINRISKI risk calculator
The FINRISKI calculator is based on data on risk factors and morbidity follow-up from participants in the FINRISKI study conducted in 1982, 1987, 1992, 2002 and 2007. Data on morbidity and mortality among study participants over the 10-year follow-up period were obtained from Finnish registers. The FINRISKI calculator provides a percentage score that indicates participant's risk of suffering a heart attack or a stroke over the next 10 years. The percentage ranges from 0 to 100 percent, and a higher value indicates a worse outcome.
Change from Baseline in the Cardiovascular Disease Risk at 6 Months assessed by Systematic Coronary Risk Evaluation 2 (SCORE2) risk calculator
The SCORE2 risk calculator provides an estimate of 10-year fatal and non-fatal cardiovascular disease risk for participants without previous CVD or diabetes aged 40-69 years in Europe. It gives a percentage score that ranges from 0 to 100 percent, and a higher value indicates a worse outcome.
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Wellbeing Services County of Pirkanmaa
Lead sponsor
Tampere University
Collaborator
This trial is not recruiting at the moment. You can still explore other options: