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Clinical Trials/NCT03908710
NCT03908710
Completed
Not Applicable

A Prospective Trial of Home Blood Pressure Levels in Hypertensive Participants Using the ACCUMBO Telemedicine Device

Accumbo AB1 site in 1 country172 target enrollmentJune 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension,Essential
Sponsor
Accumbo AB
Enrollment
172
Locations
1
Primary Endpoint
Changes in mean home blood pressure (systolic and diastolic blood pressure mmHg) during the trial using automatic oscillometric blood pressure monitor
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Aim of the study was to investigate a new clinical medical system for treatment of hypertension with a clinical decision system,a smartphone patient app and a home blood pressure monitor.

Detailed Description

Despite the extensive knowledge of the importance of treating and thus preventing complications of hypertension, the incidence of high blood pressure is increasing, and it is still the main cause of cardiovascular disease and premature death, partly due to deficiencies in preventive care and control of the disease in an aging world. Blood pressure values obtained by self-measurement at home (HBPM) have been shown to predict the cardiovascular prognosis equally well as or better than blood pressure values obtained in the clinic (CBPM) in several observational studies. Aim of the present study was to investigate a new clinical medical system for treatment of hypertension with a clinical decision system and a electronic health record, a patient app and a home blood pressure monitor. " The patient app and the doctor's record reflect each other and basically contain the same information. Doctors can treat their patients remotely and the patients are able to manage some health issues by themselves by using the applications. Some patients need the physical examination. We therefore included patients after a so-called triage step with medical questions.

Registry
clinicaltrials.gov
Start Date
June 1, 2018
End Date
October 30, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Accumbo AB
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Primary hypertension
  • Smartphone at home

Exclusion Criteria

  • Secondary hypertension,
  • previous stroke,
  • myocardial infarction,
  • known heart failure,
  • known cardiac arrhytmia,
  • known servere renal failure,
  • known dementia

Outcomes

Primary Outcomes

Changes in mean home blood pressure (systolic and diastolic blood pressure mmHg) during the trial using automatic oscillometric blood pressure monitor

Time Frame: 3 months

We investigate if the blood pressure is better in the end of the study compared with the start

Patient experience

Time Frame: 3 months

We investigate how the patients experience the medical technology system and the treatment using a questionnaire

Secondary Outcomes

  • Hypotension(3 months)

Study Sites (1)

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