Interstitial Lung DiseaseNCT01711151
Interstitial Lung Disease Questionnaire
An observational study of Interstitial Lung Disease, run by University of East Anglia at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Interstitial Lung Disease
- How many people
- 304 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2012to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Secondary Care
Who may be able to join
- 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
Who cannot join
- Unable to give consent to take part
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Norfolk and Norwich Univeristy Hospital NHS foundation Trust
Norwich, Norfolk, NR47UY
Christopher Atkins
About this study
Official title: Questionnaire Study for Patients With Interstitial Lung Disease
- To evaluate the health status of patients with Interstitial Lung Disease (ILD), and how this varies between subgroups of ILD.
- To investigate the prevalence of symptoms, anxiety, depression, and sleep-disordered breathing within ILD patient population.
- To assess the economic impact of ILD.
- To understand how self-aware ILD patients are regarding their treatment/management.
- To compare the demographic details, including smoking status and occupational history, of patients with interstitial lung disease
Read the 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
- Conditions
- Interstitial Lung Disease
- Keywords
- ILD
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic Pulmonary Fibrosis | Questionnaire evaluation | |
| Non Idiopathic Pulmonary Fibrosis | Questionnaire evaluation | |
| Sarciodosis | Questionnaire evaluation | |
| Healthy Controls | Questionnaire evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the Mean K-BILD score between the 4 groups
HRQL
Measured: Baseline
Secondary outcomes (6)
Severity of dyspnoea suffered by patients
Measured: Baseline
Prevalence of anxiety and depression
Measured: Baseline
Prevalence of sleep-disordered breathing symptoms
Measured: Baseline
Degree of self-awareness displayed by patients
Measured: Baseline
The costs associated with ILD from a patient and healthcare perspective
Measured: Baseline
Demographic details
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew M Wilson, Principal investigator, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711151
- Sponsor's protocol ID
- 2012RESP05
- Other IDs
- UEAILDQUEST
- Status last verified
- Oct 2012
- First submitted
- 9 Oct 2012
- Last updated
- 22 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Questionnaire Study for Patients With Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT01711151
- Acronym / sponsor ID
- 2012RESP05
- Conditions
- Interstitial Lung Disease
- Keywords
- ILD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 22 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To evaluate the health status of patients with Interstitial Lung Disease (ILD), and how this varies between subgroups of ILD.
- To investigate the prevalence of symptoms, anxiety, depression, and sleep-disordered breathing within ILD patient population.
- To assess the economic impact of ILD.
- To understand how self-aware ILD patients are regarding their treatment/management.
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Idiopathic Pulmonary Fibrosis | – | –Questionnaire evaluation |
| Non Idiopathic Pulmonary Fibrosis | – | –Questionnaire evaluation |
| Sarciodosis | – | –Questionnaire evaluation |
| Healthy Controls | – | –Questionnaire evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Secondary Care
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Unable to give consent to take part
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in the Mean K-BILD score between the 4 groups
Time frame: Baseline
HRQL
6 secondary outcomes
Severity of dyspnoea suffered by patients
Time frame: Baseline
Prevalence of anxiety and depression
Time frame: Baseline
Prevalence of sleep-disordered breathing symptoms
Time frame: Baseline
Degree of self-awareness displayed by patients
Time frame: Baseline
The costs associated with ILD from a patient and healthcare perspective
Time frame: Baseline
Demographic details
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew M Wilson principal investigator
University of East Anglia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease, run by University of East Anglia at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew M Wilson, MRCP, MD (00441603591257, a.m.wilson@uea.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the Mean K-BILD score between the 4 groups (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2012.