Modelling of Quality Life, Clinical and Physiological Measures in Idiopathic Pulmonary Fibrosis

NCT02176707 | Unknown DMC

• 2 other identifiers: 2014RESP03L14/SW/0047
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

As there are no validated tools for assessing patient reported outcomes or health related quality of life in idiopathic pulmonary fibrosis (IPF), different studies have utilised different methods. This means that comparison of the outcomes of studies is difficult or inaccurate. By collecting different quality of life tools and patient reported outcome at the same time, it will be possible to map or model the results of one tool or groups of tools onto another. 250 patients with IPF will be asked to complete the EuroQoL 5D, Kings Brief Interstitial Lung Disease questionnaire, St George's Respiratory Questionnaire, MRC dyspnoea scale, University of California, San Diego shortness of breath questionnaire and the Hospital Anxiety and Depression Scale, along with spirometry every 3 months, and undergo a 6 minute walk test every 6 months, over a 12 month period. Prognostic models will be constructed from all the clinical (questionnaire and function) measures a linear regression model.

Conditions

Idiopathic Pulmonary Fibrosis; Dyspnoea; Anxiety; Depression

Keywords

Lung Function; Exercise Capacity

Outcome Measures

Primary Outcomes (2)

• St George's Respiratory Questionnaire (SGRQ)

  St George's Respiratory Questionnaire (SGRQ) is a tool for assessing quality of life that has previously been validated for the use with patients with interstitial lung disease. It is a responsive tool that has three domains: symptoms, activity and impact (on daily life)

  12 month period

• Kings Brief Interstitial Lung Disease questionnaire (K-BILD)

  Kings Brief Interstitial Lung Disease questionnaire (K-BILD) Recently developed, this is a disease specific questionnaire validated to look at the health status of patients with a variety of forms of ILD. It consists of 15 items, and can be self-administered.

  12 month period

Secondary Outcomes (1)

• MRC dyspnoea scale

  12 months

Study Arms (1)

Idiopathic pulmonary fibrosis sufferers

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be identified by hospital databases, patient registries and clinical notes and approached by the patients' attending physician or clinical team.

You may qualify if:

• Age greater than 40 years.
• IPF based on multi-disciplinary following review of clinical history, thoracic high resolution computed tomography (HRCT) and/or usual interstitial pneumonia (UIP) histology confirmed by surgical lung biopsy consensus according to international guidelines.
• Patients may receive oral prednisolone up to a dose of 10 mg per day, anti-oxidant therapy or pirfenidone at study entry.

You may not qualify if:

• A recognised significant co-existing respiratory disease, defined as a respiratory condition that exhibits a clinically relevant effect on respiratory symptoms and disease progression as determined by the principal investigator following multi-disciplinary discussion. For example, patients with bronchiectasis will only be included if the bronchiectasis is deemed to be traction bronchiectasis as a result of idiopathic pulmonary fibrosis.
• Airflow obstruction defined as a FEV1/FVC\<60% predicted or a residual volume greater than 120% predicted.
• Significant medical, surgical or psychiatric disease that in the opinion of the patient's attending physician would exhibit a clinically relevant effect on the patient's health related quality of life.
• Unable to provide written informed consent.

Sponsors & Collaborators

• University of East Anglia: lead
• InterMune: collaborator

Study Sites (1)

Norwich Medical School

Norwich, Norfolk, NR47TJ, United Kingdom

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Dyspnea; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Andrew M Wilson

  University of East Anglia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2014
• First Posted: June 27, 2014
• Study Start: June 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: February 1, 2017
• Last Updated: June 13, 2016

Record last verified: 2016-06

Locations

GB (1)