Trial record 4 of 4 for:    "Alveolitis extrinsic allergic"

Supplemental Oxygen in Pulmonary Fibrosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by National Jewish Health
Sponsor:
Collaborators:
The Coalition for Pulmonary Fibrosis
Pulmonary Fibrosis Foundation
Information provided by (Responsible Party):
National Jewish Health
ClinicalTrials.gov Identifier:
NCT01961362
First received: October 9, 2013
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

To enhance understanding of supplemental oxygen—its utility in and adoption by patients with pulmonary fibrosis—by examining how patients perceive it and by determining how perceptions and patient-centered outcome measures change from before to after supplemental oxygen is prescribed.


Condition
Pulmonary Fibrosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observing the Effects of Supplemental Oxygen on Patients With Pulmonary Fibrosis

Resource links provided by NLM:


Further study details as provided by National Jewish Health:

Primary Outcome Measures:
  • Change in dyspnea from immediately prior to one month after starting daily-use supplemental oxygen [ Time Frame: One month post daily-use supplemental oxygen implementation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in quality of life, fatigue and cough from prior to one month after daily-use supplemental oxygen implementation [ Time Frame: One month after daily-use supplemental oxygen implementation ] [ Designated as safety issue: No ]
  • Change in day-to-day functioning and activity space from prior to one month after daily-use supplemental oxygen implementation [ Time Frame: One month after daily-use supplemental oxygen implementation ] [ Designated as safety issue: No ]
    Functioning will be captured by having patients wear an activity monitor, and activity space will be capture by having patients wear a mobile GPS recorder.


Estimated Enrollment: 360
Study Start Date: October 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pulmonary fibrosis patients
Patients with pulmonary fibrosis of any cause (idiopathic, connective tissue disease, chronic hypersensitivity pneumonitis)
Primary supporter/caregiver of patient with pulmonary fibrosis
We will interview primary supporters/caregivers of people living with PF to learn from a different perspective of what it's like to use supplemental oxygen, both for the person living with PF and the primary supporter him/herself.
Prescribers of supplemental oxygen
We will interview supplemental oxygen prescribers to better understand their practices around prescribing oxygen and their expectations for the patients to whom they prescribe supplemental oxygen.

Detailed Description:

The investigators aim to recruit patients with PF to participate in interviews and/or a one-year study of supplemental oxygen (O2). In the one-year study, the investigators will collect data before and for one year after PF patients are prescribed daily-use supplemental oxygen and compare outcomes, including shortness of breath, quality of life, fatigue, cough, and day-to-day functioning before and after O2.

In addition to this, the investigators will interview O2 prescribers and primary supporters/caregivers of PF patients prescribed daily-use O2 to understand the perceptions of others affected by supplemental O2.

  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

Patients with pulmonary fibrosis of any cause (idiopathic, related to connective tissue disease [e.g., rheumatoid arthritis, systemic sclerosis/scleroderma, dermato-/polymyositis, sjogren's syndrome], familial or genetic) or the primary supporter/caregiver of a patient with pulmonary fibrosis

Criteria

Inclusion Criteria:

Patient-Participants

(Using daily 02 therapy at time of enrollment)

  • Diagnosis of PF
  • Able to read and speak English
  • Has been on daily-use supplemental oxygen for more than one year

(Not using daily 02 therapy at time of enrollment)

  • Diagnosis of PF
  • Able to read, speak and write in English
  • Has not been prescribed daily-use supplemental oxygen
  • Forced vital capacity <75% and diffusing capacity <65% of predicted values
  • Subject's physician allows the subject to abstain from daily-use supplemental oxygen for 7-10 days after prescription to allow data for collection

Primary Supporters

  • Self-report status of providing care or support to a person living with pulmonary fibrosis who has used supplemental oxygen for more than one year
  • Able to speak English

O2 Prescribers

  • Self-report status of being a prescriber of daily-use supplemental oxygen to PF patients
  • Able to speak English
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01961362

Contacts
Contact: Amanda Belkin, MPH 855-609-0010 support@PFresearch.org

Locations
United States, Colorado
National Jewish Health Interstitial Lung Disease Program Recruiting
Denver, Colorado, United States, 80206
Contact: Amanda Belkin, MPH         
Sponsors and Collaborators
National Jewish Health
The Coalition for Pulmonary Fibrosis
Pulmonary Fibrosis Foundation
Investigators
Principal Investigator: Jeff Swigris, DO, MS National Jewish Health
  More Information

Additional Information:
No publications provided

Responsible Party: National Jewish Health
ClinicalTrials.gov Identifier: NCT01961362     History of Changes
Other Study ID Numbers: PCORI 4134a
Study First Received: October 9, 2013
Last Updated: October 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by National Jewish Health:
Pulmonary fibrosis
Interstitial lung disease
Connective tissue disease
Chronic hypersensitivity pneumonitis
Idiopathic pulmonary fibrosis
Pulmonary fibrosis of any cause
Primary supporters/caregivers

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 26, 2014