NCT01711151

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
304

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 22, 2012

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

October 22, 2012

Status Verified

October 1, 2012

Enrollment Period

1 year

First QC Date

October 9, 2012

Last Update Submit

October 17, 2012

Conditions

Keywords

ILD

Outcome Measures

Primary Outcomes (1)

  • Difference in the Mean K-BILD score between the 4 groups

    HRQL

    Baseline

Secondary Outcomes (6)

  • Severity of dyspnoea suffered by patients

    Baseline

  • Prevalence of anxiety and depression

    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

  • +1 more secondary outcomes

Study Arms (4)

Idiopathic Pulmonary Fibrosis

Questionnaire evaluation

Non Idiopathic Pulmonary Fibrosis

Questionnaire evaluation

Sarciodosis

Questionnaire evaluation

Healthy Controls

Questionnaire evaluation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Secondary Care

You may qualify if:

  • 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

You may not qualify if:

  • Unable to give consent to take part

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norfolk and Norwich Univeristy Hospital NHS foundation Trust

Norwich, Norfolk, NR47UY, United Kingdom

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Andrew M Wilson

    University of East Anglia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew M Wilson, MRCP, MD

CONTACT

Christopher Atkins, MBBS, MRCP

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2012

First Posted

October 22, 2012

Study Start

November 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

October 22, 2012

Record last verified: 2012-10

Locations