The SPIRO-MOTE Study

July 21, 2023 updated by: Heather Elphick, Sheffield Children's NHS Foundation Trust

Multicentre Prospective Cohort Study of Remote Lung Function Testing in Children: Validation and Comparison of Supervised and Unsupervised Spirometry

Multicentre Prospective Cohort Study of Remote Lung Function Testing in Children: validation and comparison of supervised and unsupervised spirometry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

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

  • United Kingdom
      • Sheffield, United Kingdom
        • Clinical Research Facility, Sheffield Children's Hospital

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

  • Child

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited at the four participating centres: Sheffield Children's Hospital, Leeds Children's Hospital, Royal Hospital for Children (Glasgow) and Great Ormond Street Hospital (London).

Description

Inclusion Criteria:

  • Male and female children aged 5 to 16 years old
  • Doctor diagnosed respiratory condition, including asthma, cystic fibrosis, PCD, bronchiectasis
  • Child able to perform reliable spirometry
  • Family have access to a smartphone or tablet and a second device for video consultation

Exclusion Criteria:

  • Significant learning difficulties
  • Other reasons for being unable to do lung function tests, for example, unable to make a seal around the mouthpiece
  • Informed consent/assent has not been provided
  • No English speaking member of the family
  • Contraindications as outlined by the ARTP, e.g. pneumothorax, haemoptysis of unknown origin, unstable cardiovascular status, recent eye surgery, vomiting or any acute disease that would interfere with the test performance, recent surgery (thoracic/abdominal)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcome measures from spirometry tests (1)
Time Frame: Within two weeks
The researchers will use the absolute values for FEV1 and FVC, coupled with the demographic data, to calculate FEV1/FVC, percent predicted and z-scores using a batch calculator from the GLI website. The team will record how many patients achieved technically acceptable tests, using the ATS A-F standards (9), and how many failed.
Within two weeks
Outcome measures from spirometry tests (2)
Time Frame: Within two weeks
The team will record how many patients achieved technically acceptable tests, using the ATS A-F standards (9), and how many failed.
Within two weeks
Length of each standard test
Time Frame: Within two weeks
Researchers will record how long each standard test took to carry out.
Within two weeks

Collaborators and Investigators

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

Sponsor

Sheffield Children's NHS Foundation Trust

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)

February 24, 2021

Primary Completion (Actual)

May 31, 2022

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

April 19, 2023

First Submitted That Met QC Criteria

July 21, 2023

First Posted (Actual)

July 25, 2023

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • SCH-2539

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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