Telemedical Algorithm-Supported Care for Hypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPoznan University of Medical Sciences
About this trial
Hypertension is a major global health issue, affecting around 9 million people in Poland. While some studies indicate that telemonitoring benefits patients with hypertension, there is a lack of research evaluating tools that assist doctors in managing these patients. The objective of this study is to assess a blood pressure monitoring system with an integrated algorithm that aids doctors in the decision-making process.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily signing an informed consent to participate in the study.
Age between 18 and 80 years.
Diagnosis of hypertension according to the Polish Society of Hypertension criteria from 2019, either already treated or newly diagnosed.
Blood pressure exceeding 140/90 mmHg in office measurements (during the screening visit).
Disqualifiers
Suspicion or diagnosis of secondary hypertension.
Pregnant women, breastfeeding women, or those planning pregnancy during the study period.
Trial design
Design model
Parallel
Treatments tested in this trial
Evaluation of a blood pressure monitoring system with an integrated algorithm that supports the doctor's decision-making process
Other interventionReceiving remote care facilitated by a specialized informatic system to support the physician
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Control groupNo intervention 0 interventions
Group B: Study groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Assessment of Achieving Arterial Blood Pressure Control
Time from study initiation to the day of achieving arterial blood pressure control, defined as a 7-day mean of home blood pressure measurements below 135/85 mmHg
Time frame
After completing the presumed six-month follow-up of the last participant2
Assessment of Achieving Arterial Blood Pressure control at 6 months
The time from study initiation to 6 months of participation, achieving arterial blood pressure control, defined as a 7-day average of home blood pressure measurements below 135/85 mmHg
Time frame
After 6 months of participatingSecondary outcomes
1
Assessment of blood pressure values in 24-hour monitoring, home measurements, and office measurements
Analysis of Blood Pressure Values: 24-Hour Monitoring, Home Measurements, and Office Measurements
Time frame
Baseline up to approximately six-months of observation2
Assessment of the number of the medical visits
The number of medical visits from study initiation to completion
Time frame
After completing the presumed six-month follow-up of the last participant3
Assessment of the maintaining blood pressure control
Total time maintaining blood pressure control, defined as the number of days with a 7-day mean of home measurements below 135/85 mmHg
Time frame
After completing the presumed six-month follow-up of the last participant4
Assessment of the cost of visits
Cost of visits incurred by the medical institution and the patient
Time frame
After completing the presumed six-month follow-up of the last participantSponsors and contacts
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Source ClinicalTrials.gov