Interstitial Lung Disease Questionnaire

October 17, 2012 updated by: University of East Anglia

Questionnaire Study for Patients With Interstitial Lung Disease

  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

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

304

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR47UY
        • Norfolk and Norwich Univeristy Hospital NHS foundation Trust
        • Sub-Investigator:
          • Christopher Atkins

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Secondary Care

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Idiopathic Pulmonary Fibrosis
Questionnaire evaluation
Non Idiopathic Pulmonary Fibrosis
Questionnaire evaluation
Sarciodosis
Questionnaire evaluation
Healthy Controls
Questionnaire evaluation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of East Anglia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

November 1, 2013

Study Completion (Anticipated)

November 1, 2013

Study Registration Dates

First Submitted

October 9, 2012

First Submitted That Met QC Criteria

October 17, 2012

First Posted (Estimate)

October 22, 2012

Study Record Updates

Last Update Posted (Estimate)

October 22, 2012

Last Update Submitted That Met QC Criteria

October 17, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012RESP05
  • UEAILDQUEST (Other Identifier: University of East Anglia)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Interstitial Lung Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe