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The Accumbo Home Blood Pressure Trial

Primary Purpose

Hypertension,Essential

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Treatment of hypertension using blood pressure self-measurement at home
Sponsored by
Accumbo AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension,Essential focused on measuring Home blood pressure monitor, Telemedicine, mHealth, eHealth

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Martin Carlsson,

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

home Home blood pressure levels in hypertensive participants

Arm Description

Only one arm. No control group.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 7, 2019
Last Updated
April 10, 2019
Sponsor
Accumbo AB
Collaborators
University Hospital, Linkoeping
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1. Study Identification

Unique Protocol Identification Number
NCT03908710
Brief Title
The Accumbo Home Blood Pressure Trial
Official Title
A Prospective Trial of Home Blood Pressure Levels in Hypertensive Participants Using the ACCUMBO Telemedicine Device
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Accumbo AB
Collaborators
University Hospital, Linkoeping

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension,Essential
Keywords
Home blood pressure monitor, Telemedicine, mHealth, eHealth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

Arm Title
home Home blood pressure levels in hypertensive participants
Arm Type
Other
Arm Description
Only one arm. No control group.
Intervention Type
Other
Intervention Name(s)
Treatment of hypertension using blood pressure self-measurement at home
Intervention Description
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 Outcome Measure Information:
Title
Changes in mean home blood pressure (systolic and diastolic blood pressure mmHg) during the trial using automatic oscillometric blood pressure monitor
Description
We investigate if the blood pressure is better in the end of the study compared with the start
Time Frame
3 months
Title
Patient experience
Description
We investigate how the patients experience the medical technology system and the treatment using a questionnaire
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Hypotension
Description
We investigate how many patients have hypotension/ortosstatism in the beginning of the study compared in the end of the study
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Carlsson, MD,PhD
Organizational Affiliation
Accumbo AB
Official's Role
Principal Investigator
Facility Information:
Facility Name
Martin Carlsson,
City
Kalmar
ZIP/Postal Code
S-39130
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.accumbo.se
Description
Related Info

Learn more about this trial

The Accumbo Home Blood Pressure Trial

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