The Accumbo Home Blood Pressure Trial

• Sponsor: Accumbo AB (Other)
• Overall Status: Completed
• CT.gov ID: NCT03908710
• Collaborator: University Hospital, Linkoeping (Other)
• Enrollment: 172
• Location: 1
• Arm: 1
• Actual Duration (Months): 5
• Patients Per Site Per Month: 34.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension,Essential	Other: Treatment of hypertension using blood pressure self-measurement at home	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 172 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Trial of Home Blood Pressure Levels in Hypertensive Participants Using the ACCUMBO Telemedicine Device
• Actual Study Start Date: Jun 1, 2018
• Actual Primary Completion Date: Oct 30, 2018
• Actual Study Completion Date: Oct 30, 2018

Arms and Interventions

Arm

Intervention/Treatment

Other: home Home blood pressure levels in hypertensive participants Only one arm. No control group.

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

Outcome Measures

Primary Outcome Measures

1. 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

2. Patient experience [3 months]

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

Secondary Outcome Measures

1. Hypotension [3 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Martin Carlsson,	Kalmar		Sweden	S-39130

Sponsors and Collaborators

• Accumbo AB
• University Hospital, Linkoeping

Investigators

• Principal Investigator: Martin Carlsson, MD,PhD, Accumbo AB

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Accumbo AB
• ClinicalTrials.gov Identifier: NCT03908710
• Other Study ID Numbers: Accumbo AB (Accumbo)
• First Posted: Apr 9, 2019
• Last Update Posted: Apr 11, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Accumbo AB: Home blood pressure monitor; Telemedicine; mHealth; eHealth
• Additional relevant MeSH terms: Essential Hypertension

Study Results

No Results Posted as of Apr 11, 2019