The Accumbo Home Blood Pressure Trial

Hypertension,Essential Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03908710
• Other study ID #: Accumbo AB (Accumbo)
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: October 30, 2018

Study information

• Verified date: April 2019
• Source: Accumbo AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: October 30, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension,Essential

Intervention

Other:
• Treatment 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

Locations

Country	Name	City	State
Sweden	Martin Carlsson,	Kalmar

Sponsors (2)

Lead Sponsor	Collaborator
Accumbo AB	University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in mean home blood pressure (systolic and diastolic blood pressure mmHg) during the trial using automatic oscillometric blood pressure monitor	We investigate if the blood pressure is better in the end of the study compared with the start	3 months
Primary	Patient experience	We investigate how the patients experience the medical technology system and the treatment using a questionnaire	3 months
Secondary	Hypotension	We investigate how many patients have hypotension/ortosstatism in the beginning of the study compared in the end of the study	3 months

External Links

•   Link