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The Accumbo Home Blood Pressure Trial

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03908710
Enrollment
172
Registered
2019-04-09
Start date
2018-06-01
Completion date
2018-10-30
Last updated
2019-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension,Essential

Keywords

Home blood pressure monitor, Telemedicine, mHealth, eHealth

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.

Interventions

OTHERTreatment of hypertension using blood pressure self-measurement at home

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

Sponsors

University Hospital, Linkoeping
CollaboratorOTHER
Accumbo AB
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in mean home blood pressure (systolic and diastolic blood pressure mmHg) during the trial using automatic oscillometric blood pressure monitor3 monthsWe investigate if the blood pressure is better in the end of the study compared with the start
Patient experience3 monthsWe investigate how the patients experience the medical technology system and the treatment using a questionnaire

Secondary

MeasureTime frameDescription
Hypotension3 monthsWe investigate how many patients have hypotension/ortosstatism in the beginning of the study compared in the end of the study

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026