The Accumbo Home Blood Pressure Trial

Not Applicable

Completed

• Conditions: Hypertension,Essential
• Interventions: Other: Treatment of hypertension using blood pressure self-measurement at home

• Registration Number: NCT03908710
• Lead Sponsor: Accumbo AB

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.

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2018-10-30
• Study Completion: 2018-10-30
• Status Verified: 2019-04
• Study First Submitted: 2019-04-07
• Study First Submitted QC: 2019-04-07
• Study First Posted: 2019-04-09
• Last Update Submitted: 2019-04-10
• Last Update Posted: 2019-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
home Home blood pressure levels in hypertensive participants	Treatment of hypertension using blood pressure self-measurement at home	Only one arm. No control group.

Primary Outcome Measures

Name	Time	Method
Changes in mean home blood pressure (systolic and diastolic blood pressure mmHg) during the trial using automatic oscillometric blood pressure monitor	3 months	We investigate if the blood pressure is better in the end of the study compared with the start
Patient experience	3 months	We investigate how the patients experience the medical technology system and the treatment using a questionnaire

Secondary Outcome Measures

Name	Time	Method
Hypotension	3 months	We investigate how many patients have hypotension/ortosstatism in the beginning of the study compared in the end of the study

Trial Locations

Locations (1)

Martin Carlsson,; 🇸🇪 Kalmar, Sweden