NCT03264417

Brief Summary

A multicentric study to explore variability when clinicians are intrepreting lung function tests. Comparison with results of in-house built software for automatic interpretation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2017

Shorter than P25 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

First Submitted

Initial submission to the registry

August 1, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

5 months

First QC Date

August 1, 2017

Last Update Submit

September 3, 2018

Conditions

Respiratory Disease

Outcome Measures

Primary Outcomes (1)

  • Interclass correlation coëfficiënt for whole group

    Variation in preferred primary diagnosis of respiratory disease given by every physician for every case (selection of one diagnosis out of a fixed panel of 9 possible diagnoses).

    6 months

Secondary Outcomes (6)

  • Interclass correlation coëfficiënt for every case

    6 months

  • Accuracy of physicians expressed as a percentage of correct diagnoses per case (%)

    6 months

  • Accuracy of physicans expressed as a percentage of correct diagnoses in total group (%)

    6 months

  • Accuracy of physicians expressed as a percentage of correct diagnoses per hospital (group) (%)

    6 months

  • Accuracy of software expressed as a percentage of correct diagnoses in total group, per hospital and per case

    6 months

  • +1 more secondary outcomes

Eligibility Criteria

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

Subjects with or without respiratory complaints undergo subset of (or complete) pulmonary function tests

You may qualify if:

  • Age more than 18 years
  • Completed one or more pulmonary function tests

You may not qualify if:

  • Younger than 18
  • Lung transplantation, lung cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Wim Janssens, Prof. Dr.

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

August 1, 2017

First Posted

August 29, 2017

Study Start

August 1, 2017

Primary Completion

December 30, 2017

Study Completion

April 1, 2018

Last Updated

September 5, 2018

Record last verified: 2018-09

Locations

BE(1)