NCT04463524

Brief Summary

This study aimed to analyze the usefulness of telecardiology in the primary health care level using an ECG personal sensor developed in Slovenia.Investigators also wanted to evaluate the satisfaction of patients and their physicians and the cost-effectiveness of this tool.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Typical duration for all trials

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

October 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

1.3 years

First QC Date

June 22, 2020

Last Update Submit

July 3, 2020

Conditions

Cardiac Arrhythmia

Keywords

Heart rhythm disorderpalpitationprimary healthcarepersonal mobile ECG sensorreferral

Outcome Measures

Primary Outcomes (1)

  • Change from no detected hearth rhythm disorders to diagnosed hearth rhythm disorders at day 90

    With the help of ECG sensor finding arrhythmias in patients where standard ECG record was normal. Change = (day 90 record - baseline record)

    baseline and day 90

Secondary Outcomes (1)

  • Change in patients and doctors satisfaction with this method after detecting possible hearth rhythm disorders

    baseline and day 90

Study Arms (2)

Test

They will receive ECG sensor after initial standard 12-channel ECG record will be taken; they will return after 5 days and after 3 months to assess their hearth rhythm disorders and actions taken.

Device: Personal ECG digital sensor

Control

They will not receive ECG sensor after initial standard 12-channel ECG record will be taken; they will return after 5 days and after 3 months to assess their hearth rhythm disorders and actions taken.

Device: Personal ECG digital sensor

Interventions

Personal ECG digital sensorDEVICE

Patients in test group will receive personal ECG sensor and in control gropu will not.

Also known as: Savvy Personal ECG digital sensor
ControlTest

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who come to their family physician with the complaint of hearth rhythm disorder as selected time. Their family physicians are also included.

You may qualify if:

  • age over 18 years,
  • there was a history of suspected arrhythmia,
  • at the time of examination, the ECG is within normal limits
  • the patient has never been treated for any heart rhythm disorder.

You may not qualify if:

  • age less than 18 years,
  • on examination on the ECG, the patient was not in sinus rhythm, and
  • that the patient has a known heart rhythm disorder and / or is being treated for it.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health care center Murska Sobota

Murska Sobota, 9000, Slovenia

Location

Related Publications (4)

  • Mistry H. Systematic review of studies of the cost-effectiveness of telemedicine and telecare. Changes in the economic evidence over twenty years. J Telemed Telecare. 2012 Jan;18(1):1-6. doi: 10.1258/jtt.2011.110505. Epub 2011 Nov 18.

    PMID: 22101609BACKGROUND

  • Lieberman J. How telemedicine is aiding prompt ECG diagnosis in primary care. Br J Community Nurs. 2008 Mar;13(3):123-6. doi: 10.12968/bjcn.2008.13.3.28676.

    PMID: 18557568RESULT

  • Orchard J, Freedman SB, Lowres N, Peiris D, Neubeck L. iPhone ECG screening by practice nurses and receptionists for atrial fibrillation in general practice: the GP-SEARCH qualitative pilot study. Aust Fam Physician. 2014 May;43(5):315-9.

    PMID: 24791776RESULT

  • Klein-Wiele O, Faghih M, Dreesen S, Urbien R, Abdelghafor M, Kara K, Schulte-Hermes M, Garmer M, Gronemeyer D, Hailer B. A novel cross-sector telemedical approach to detect arrhythmia in primary care patients with palpitations using a patient-activated event recorder. Cardiol J. 2016;23(4):422-8. doi: 10.5603/CJ.a2016.0033. Epub 2016 Jun 20.

    PMID: 27320955RESULT

Related Links

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stasa Vodicka, MD

    Health care center Murska Sobota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
asist. prof. Stasa Vodicka, MD

Study Record Dates

First Submitted

June 22, 2020

First Posted

July 9, 2020

Study Start

October 1, 2016

Primary Completion

January 1, 2018

Study Completion

August 1, 2019

Last Updated

July 9, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)