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Completed

NCT Number: NCT03908710

The Accumbo Home Blood Pressure Trial

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.

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Key information

Conditions

Hypertension,Essential Cardiovascular Diseases Essential Hypertension Hypertension Vascular Diseases

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Martin Carlsson,

Kalmar, S-39130, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment of hypertension using blood pressure self-measurement at home

Other

The primary aim of the present study is to investigate whether home blood pressure recording via Bluetooth and continuous communication between doctor and patient will give improved blood pressure values when comparing the initial values with the blood pressure values recorded after 3 months. Secondary examinations include treatment of hypotension and adverse events, the patient's experience, the user's potential problems with the blood pressure cuff, app downloading, problems with history issues or problems with technical

Primary outcomes

  1. 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

  2. Patient experience

    Time frame: 3 months

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

Secondary outcomes

  1. Hypotension

    Time frame: 3 months

    We investigate how many patients have hypotension/ortosstatism in the beginning of the study compared in the end of the study

Sponsors and collaborators

Lead sponsor

Accumbo AB

Other

Collaborators

  • University Hospital, Linkoeping

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 9, 2019
Registry last updated
Apr 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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