Interstitial Lung Disease Questionnaire

• Conditions: Interstitial Lung Disease

• Registration Number: NCT01711151
• Lead Sponsor: University of East Anglia

Brief 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

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

Study Timeline

• Status Verified: 2012-10
• Study First Submitted: 2012-10-09
• Study First Submitted QC: 2012-10-17
• Last Update Submitted: 2012-10-17
• Study First Posted: 2012-10-22
• Last Update Posted: 2012-10-22
• Study Start: 2012-11
• Primary Completion: 2013-11
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 304

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

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Exclusion Criteria

• Unable to give consent to take part

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in the Mean K-BILD score between the 4 groups	Baseline	HRQL

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Norfolk and Norwich Univeristy Hospital NHS foundation Trust; 🇬🇧 Norwich, Norfolk, United Kingdom