Interstitial Lung Disease Questionnaire

Interstitial Lung Disease Clinical Trial

Official title:

Questionnaire Study for Patients With Interstitial Lung Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01711151
• Other study ID #: 2012RESP05
• Secondary ID: UEAILDQUEST
• Status: Not yet recruiting
• Phase: N/A
• First received: October 9, 2012
• Last updated: October 17, 2012
• Start date: November 2012
• Est. completion date: November 2013

Study information

• Verified date: October 2012
• Source: University of East Anglia
• Contact: Andrew M Wilson, MRCP, MD
• Phone: 00441603591257
• Email: a.m.wilson[@]uea.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

1. To evaluate the health status of patients with Interstitial Lung Disease (ILD), and how this varies between subgroups of ILD.

2. To investigate the prevalence of symptoms, anxiety, depression, and sleep-disordered breathing within ILD patient population.

3. To assess the economic impact of ILD.

4. To understand how self-aware ILD patients are regarding their treatment/management.

5. To compare the demographic details, including smoking status and occupational history, of patients with interstitial lung disease

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 304
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Locations

Country	Name	City	State
United Kingdom	Norfolk and Norwich Univeristy Hospital NHS foundation Trust	Norwich	Norfolk

Sponsors (1)

Lead Sponsor	Collaborator
University of East Anglia

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in the Mean K-BILD score between the 4 groups	HRQL	Baseline	No
Secondary	Severity of dyspnoea suffered by patients		Baseline	No
Secondary	Prevalence of anxiety and depression		Baseline	No
Secondary	Prevalence of sleep-disordered breathing symptoms		Baseline	No
Secondary	Degree of self-awareness displayed by patients		Baseline	No
Secondary	The costs associated with ILD from a patient and healthcare perspective		Baseline	No
Secondary	Demographic details		Baseline	No