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Trial record 13 of 394 for:    Wilson Disease
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Interstitial Lung Disease Questionnaire

This study is not yet open for participant recruitment.
Verified October 2012 by University of East Anglia
Sponsor:
Information provided by (Responsible Party):
University of East Anglia
ClinicalTrials.gov Identifier:
NCT01711151
First received: October 9, 2012
Last updated: October 17, 2012
Last verified: October 2012
History of Changes
  Purpose
  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

Condition
Interstitial Lung Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Questionnaire Study for Patients With Interstitial Lung Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of East Anglia:

Primary Outcome Measures:
  • Difference in the Mean K-BILD score between the 4 groups [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    HRQL


Secondary Outcome Measures:
  • Severity of dyspnoea suffered by patients [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Prevalence of anxiety and depression [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Prevalence of sleep-disordered breathing symptoms [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Degree of self-awareness displayed by patients [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • The costs associated with ILD from a patient and healthcare perspective [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Demographic details [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 304
Study Start Date: November 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Idiopathic Pulmonary Fibrosis
Questionnaire evaluation
Non Idiopathic Pulmonary Fibrosis
Questionnaire evaluation
Sarciodosis
Questionnaire evaluation
Healthy Controls
Questionnaire evaluation

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Secondary Care

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01711151

Contacts
Contact: Andrew M Wilson, MRCP, MD 00441603591257 a.m.wilson@uea.ac.uk
Contact: Christopher Atkins, MBBS, MRCP 00441603286286 christopher.atkins@nnuh.nhs.uk

Locations
United Kingdom
Norfolk and Norwich Univeristy Hospital NHS foundation Trust Not yet recruiting
Norwich, Norfolk, United Kingdom, NR47UY
Sub-Investigator: Christopher Atkins            
Sponsors and Collaborators
University of East Anglia
Investigators
Principal Investigator: Andrew M Wilson University of East Anglia
  More Information

No publications provided

Responsible Party: University of East Anglia
ClinicalTrials.gov Identifier: NCT01711151     History of Changes
Other Study ID Numbers: 2012RESP05, UEAILDQUEST
Study First Received: October 9, 2012
Last Updated: October 17, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of East Anglia:
ILD

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Fibrosis
Lung Diseases, Interstitial
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013