Auto-evaluation of Dyspnea | NCT03598569

Studies
Auto-evaluation of Dyspnea

NCT03598569

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Completed

Last Update Posted

Jul 26, 2018Actual

Enrollment

271Actual

Phase

Not provided

Conditions

Lung Diseases

Interventions

dyspnea

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013Actual

Primary Completion Date

Jul 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jul 15, 2018

First Submission Date that Met QC Criteria

Jul 15, 2018

First Posted Date

Jul 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2018

Last Update Posted Date

Jul 26, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary aim of this study was to compare patients-rated evaluation and caregiver's assessment of dyspnea with the standard tools in pulmonology unit (Borg scale and visual analog scale) and the secondary aim was to performed an analysis depending on the diseases (lung cancer vs. other lung diseases) and to verify the agreement between the evaluation between both visual analog scale and modified Borg scale.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

271Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lung cancer			Other: dyspnea
other lung diseases			Other: dyspnea

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dyspnea	Other	dyspnea assessment	lung cancer other lung diseases

Measure	Description	Time Frame
visual analog scale		3 seconds
borg scale		3 seconds

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age ≥18 and
to have a diagnosis of acute or chronic respiratory disease

Exclusion Criteria:

mental or cognitive disorders
inability to understand the local language

Accepts Healthy Volunteers

Not provided

Sex

Not provided

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

all lung diseases

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cliniques universitaires Saint-Luc		Brussels		1200	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided