Efficacy of Snap on Symptomatic Arrhythmia

July 24, 2020 updated by: Chunjian Li, The First Affiliated Hospital with Nanjing Medical University

Assessment of Portable Remote Health Monitor Using the Snap to Symptomatic Arrhythmia

Participants in the Snap arm were instructed to undertake once-day recording and transmission of a 30-second single-lead iECG trace to a secure server, plus additional submissions if symptomatic over a 3-month period. Snap traces were analyzed by an automated analysis software and cardiologists. Clinical review and appropriate care was arranged for those clinically significant arrhythmia. Patients in the RC group were followed up as normal methods including ECG, Holter.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Individuals with symptomatic arrhythmia without known arrhythmia were recruited.

Participants were required to have access to the internet via WiFi and to be able to operate the Snap system after simple instruction. Written consent was obtained, and eligible participants were randomized (1:1) to an intervention (Snap) group or RC group.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Not yet recruiting
        • The First Affiliated Hospital of Nanjing Medical University
        • Contact:
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Dyno
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • symptomatic arrhythmia

Exclusion Criteria:

  • can not use the Snap instrument and Sign informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Snap group
individuals in this arm used Snap according to the instruction on time and screened at the symptomatic
Diagnostic test: Snap
screen, transmission, and analysis ECG automated
NO_INTERVENTION: RC group
patients in the RC arm accepted normal methods

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluating the ability of handheld device with remote interpretation to screen for arrhythmia
Time Frame: 3-month
Participants in Snap group acquired ECG once od according to the rules and transmitted ECG immediately once symptom appeared between 3-month. Patients in the routine treatment (RT) group were administrated normal diagnostic techniques. At 3-month, compared the incidence atrial arrhythmia(atrial premature beats and atrial tachycardia) and ventricula arrhythmia(ventricular premature beats and ventricular tachycardia) between two groups.
3-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluating the patients' quality of life
Time Frame: 3-month

Using RAND 36-Item Short Form Health Survey (SF-36) 1.0 Questionnaire items assessed the quality of life of participants. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. Pricing depends on the number of scores that the researcher needs to calculate.

The eight sections are: vitality, physical functioning, bodily pain, general, health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. The total scale ranges from 35 to 145. The higher the total score, the better the patient's quality of life.
3-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Study Chair: Chun-Jian Li, PHD, The First Affiliated Hospital with Nanjing Medical University
  • Principal Investigator: Jin-Shuang Li, MD, Suqian People's Hospital of Nanjing Drum Tower Hospital Group
  • Study Chair: Liang-Hong Ying, MD, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 30, 2018

Primary Completion (ANTICIPATED)

November 30, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

December 7, 2017

First Submitted That Met QC Criteria

January 9, 2018

First Posted (ACTUAL)

January 10, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 28, 2020

Last Update Submitted That Met QC Criteria

July 24, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 009 (Other Identifier: Nahrain Medical Research Collective (NMRC))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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