NCT03908710

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2019

Completed
Last Updated

April 11, 2019

Status Verified

April 1, 2019

Enrollment Period

5 months

First QC Date

April 7, 2019

Last Update Submit

April 10, 2019

Conditions

Hypertension,Essential

Keywords

Home blood pressure monitorTelemedicinemHealtheHealth

Outcome Measures

Primary Outcomes (2)

  • 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

  • Patient experience

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

    3 months

Secondary Outcomes (1)

  • Hypotension

    3 months

Study Arms (1)

home Home blood pressure levels in hypertensive participants

OTHER

Only one arm. No control group.

Other: Treatment of hypertension using blood pressure self-measurement at home

Interventions

Treatment of hypertension using blood pressure self-measurement at homeOTHER

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

home Home blood pressure levels in hypertensive participants

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary hypertension
  • Smartphone at home

You may not qualify if:

  • Secondary hypertension,
  • previous stroke,
  • myocardial infarction,
  • known heart failure,
  • known cardiac arrhytmia,
  • known servere renal failure,
  • known dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Martin Carlsson,

Kalmar, S-39130, Sweden

Location

Related Links

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Martin Carlsson, MD,PhD

    Accumbo AB

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2019

First Posted

April 9, 2019

Study Start

June 1, 2018

Primary Completion

October 30, 2018

Study Completion

October 30, 2018

Last Updated

April 11, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)