Interstitial Lung Disease Questionnaire | NCT01711151

Studies
Interstitial Lung Disease Questionnaire

NCT01711151

Sponsor

University of East Anglia

Status

Unknown status

Last Update Posted

Oct 22, 2012Estimated

Enrollment

304Estimated

Phase

Not provided

Conditions

Interstitial Lung Disease

Interventions

Not provided

Countries

United Kingdom

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

ID	Type	Description	Link
UEAILDQUEST	Other Identifier	University of East Anglia

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Nov 2013Estimated

Completion Date

Nov 2013Estimated

First Submitted Date

Oct 9, 2012

First Submission Date that Met QC Criteria

Oct 17, 2012

First Posted Date

Oct 22, 2012Estimated

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

Oct 17, 2012

Last Update Posted Date

Oct 22, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

To evaluate the health status of patients with Interstitial Lung Disease (ILD), and how this varies between subgroups of ILD.
To investigate the prevalence of symptoms, anxiety, depression, and sleep-disordered breathing within ILD patient population.
To assess the economic impact of ILD.
To understand how self-aware ILD patients are regarding their treatment/management.
To compare the demographic details, including smoking status and occupational history, of patients with interstitial lung disease

Detailed Description

Primary endpoint

• Health status in the target populations, as determined by the K-BILD questionnaire.

Secondary endpoints -

Severity of dyspnoea suffered by patients
Prevalence of anxiety and depression
Prevalence of sleep-disordered breathing symptoms
Degree of self-awareness displayed by patients
The costs associated with ILD from a patient and healthcare perspective.
Demographic details

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

304Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Idiopathic Pulmonary Fibrosis		Questionnaire evaluation
Non Idiopathic Pulmonary Fibrosis		Questionnaire evaluation
Sarciodosis		Questionnaire evaluation
Healthy Controls		Questionnaire evaluation

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference in the Mean K-BILD score between the 4 groups	HRQL	Baseline

Secondary Outcomes

Measure	Description	Time Frame
Severity of dyspnoea suffered by patients		Baseline
Prevalence of anxiety and depression		Baseline
Prevalence of sleep-disordered breathing symptoms

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female
Age greater than 18 years of age
Any smoking status
Diagnosis of Interstitial Lung Disease as defined below
Full pulmonary lung function tests and routine immunological tests undertaken within 6 months of entry into study

Exclusion Criteria:

• Unable to give consent to take part

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Secondary Care

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andrew M Wilson, MRCP, MD	Contact	00441603591257		a.m.wilson@uea.ac.uk
Christopher Atkins, MBBS, MRCP	Contact	00441603286286		christopher.atkins@nnuh.nhs.uk

Overall Officials

Name	Affiliation	Role
Andrew M Wilson	University of East Anglia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Norfolk and Norwich Univeristy Hospital NHS foundation Trust		Norwich	Norfolk	NR47UY	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D017563	Lung Diseases, Interstitial

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided