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Idiopathic Pulmonary FibrosisIPFNCT03480451

Targeted Intervention for Patient Centered Outcome in Patients With Idiopathic Pulmonary Fibrosis

A study testing Multi-Disciplinary Patient Centered Rehab and Education in people with Idiopathic Pulmonary Fibrosis, run by Medical College of Wisconsin at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Idiopathic pulmonary fibrosis (IPF), a chronic fibrotic lung disease of unknown cause, is characterized by relentless progression, with a three-year mortality of up to 50%. IPF has high morbidity, with 90% of patients reporting dyspnea at the time of diagnosis and this is strongly correlated with quality of life and… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
Multi-Disciplinary Patient Centered Rehab and Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
12 Sep 2017to 1 Feb 2019
Phase
Interventional
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of IPF confirmed by lung biopsy or by characteristic pattern on high resolution computed tomogram (HRCT)
  • No identifiable cause of lung fibrosis
  • PR not received in the past year
  • Ability to walk

Who cannot join

  • History of unstable angina
  • Deterioration cardiac or neurological disease
  • Pregnancy or lactation
  • Degenerative arthritis or other limitation to mobility
  • PR in the past 12 months

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Froedtert Memorial Lutheran Hospital

    Milwaukee, Wisconsin, 53226

Other trials in United States

About this study

Idiopathic pulmonary fibrosis (IPF), a chronic fibrotic lung disease of unknown cause, is characterized by relentless progression, with a three-year mortality of up to 50%. IPF has high morbidity, with 90% of patients reporting dyspnea at the time of diagnosis and this is strongly correlated with quality of life and mortality. As IPF progress, breathlessness worsens, physical functional capacity declines, and health-related quality of life deteriorates. Pulmonary rehabilitation (PR) can improve well-being in patients with other chronic lung disease, but little is known regarding PR in IPF.

Read the detailed description

The hypothesis is that the provision of a comprehensive pulmonary rehabilitation program to patients with IPF will significantly improve participant health related quality of life. The objective is to develop a comprehensive, multi-disciplinary 12-week PR program with disease specific educational components for IPF patients. The specific aims of the proposal is to evaluate the effect of the comprehensive PR program on 1) improvements in quality of life using the Medical Outcomes Study 36-Item Short Form 36 (SF-36), a quality of life instrument and 2) improvements in patient self-reported dyspnea scores using the chronic respiratory questionnaire. The investigator intends to evaluate sustained benefits of the PR intervention, changes in depression, anxiety, stress and functional physical capacity.

Being tested
Multi-Disciplinary Patient Centered Rehab and Education
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi-Disciplinary Patient Centered Rehab and EducationOther

    This project is being withdrawn. No revisions to Intervention is available.

    Patients will undergo consultation and education by members of a pre-determined multi-disciplinary team that aims to bring a predetermined set of services to the patient in a coordinated and scheduled manner in order to facilitate a comprehensive and through approach to the patient's entire well being

Study groups in NCT03480451
Study groupRoleWhat they receive
Single ArmOtherThis project is being withdrawn. No revisions to ARM is available. Patients will undergo consultation and education by members of a pre-determined multi-disciplinary team that aims to bring a predetermined set of services to the patient in a coordinated and scheduled manner in order to facilitate a comprehensive and through approach to the patient's entire well being
Receives: Other: Multi-Disciplinary Patient Centered Rehab and Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess the change in coping skills for patients with IPF before and after a comprehensive pulmonary rehabilitation program.

    This project is being withdrawn. No revisions to Outcomes is available. Will use COPE questionnaire.

    Measured: 12 months

  2. Assess the change in quality of life for patients with IPF before and after a comprehensive pulmonary rehabilitation program.

    Will use 36-item SF questionnaire.

    Measured: 12 months

  3. Assess the change in depression, anxiety for patients with IPF before and after a comprehensive pulmonary rehabilitation program.

    Will use DASS-21 questionnaire.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2018
  2. Study start12 Sep 2017
  3. Primary completion1 May 2018
  4. Study completion1 Feb 2019

Why it stopped: Study considered futile

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03480451
Sponsor's protocol ID
28280
Acronym
IPF
Status last verified
Jul 2019
First submitted
12 Dec 2016
Last updated
8 Jul 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.

    PubMed 21471066

  • Meltzer EB, Noble PW. Idiopathic pulmonary fibrosis. Orphanet J Rare Dis. 2008 Mar 26;3:8. doi: 10.1186/1750-1172-3-8.

    PubMed 18366757

  • Bjoraker JA, Ryu JH, Edwin MK, Myers JL, Tazelaar HD, Schroeder DR, Offord KP. Prognostic significance of histopathologic subsets in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 1998 Jan;157(1):199-203. doi: 10.1164/ajrccm.157.1.9704130.

    PubMed 9445300

  • Swigris JJ, Kuschner WG, Jacobs SS, Wilson SR, Gould MK. Health-related quality of life in patients with idiopathic pulmonary fibrosis: a systematic review. Thorax. 2005 Jul;60(7):588-94. doi: 10.1136/thx.2004.035220.

    PubMed 15994268

  • Olson AL, Brown KK, Swigris JJ. Understanding and optimizing health-related quality of life and physical functional capacity in idiopathic pulmonary fibrosis. Patient Relat Outcome Meas. 2016 May 17;7:29-35. doi: 10.2147/PROM.S74857. eCollection 2016.

    PubMed 27274328

  • Belkin A, Swigris JJ. Health-related quality of life in idiopathic pulmonary fibrosis: where are we now? Curr Opin Pulm Med. 2013 Sep;19(5):474-9. doi: 10.1097/MCP.0b013e328363f479.

    PubMed 23851327

  • Morisset J, Dube BP, Garvey C, Bourbeau J, Collard HR, Swigris JJ, Lee JS. The Unmet Educational Needs of Patients with Interstitial Lung Disease. Setting the Stage for Tailored Pulmonary Rehabilitation. Ann Am Thorac Soc. 2016 Jul;13(7):1026-33. doi: 10.1513/AnnalsATS.201512-836OC.

    PubMed 27064659

  • Lacasse Y, Martin S, Lasserson TJ, Goldstein RS. Meta-analysis of respiratory rehabilitation in chronic obstructive pulmonary disease. A Cochrane systematic review. Eura Medicophys. 2007 Dec;43(4):475-85.

    PubMed 18084170

  • Nici L, ZuWallack R; American Thoracic Society Subcommittee on Integrated Care of the COPD Patient. An official American Thoracic Society workshop report: the Integrated Care of The COPD Patient. Proc Am Thorac Soc. 2012 Mar;9(1):9-18. doi: 10.1513/pats.201201-014ST.

    PubMed 22421582

  • Harrison SL, Greening NJ, Williams JE, Morgan MD, Steiner MC, Singh SJ. Have we underestimated the efficacy of pulmonary rehabilitation in improving mood? Respir Med. 2012 Jun;106(6):838-44. doi: 10.1016/j.rmed.2011.12.003. Epub 2011 Dec 23.

    PubMed 22197576

Questions about this trial

What is this clinical trial studying?

A study testing Multi-Disciplinary Patient Centered Rehab and Education in people with Idiopathic Pulmonary Fibrosis, run by Medical College of Wisconsin at 1 site in United States.

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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 8 Jul 2019. 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 States. 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?

The study was stopped early (reason given: Study considered futile). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess the change in coping skills for patients with IPF before and after a comprehensive pulmonary rehabilitation program. (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03480451, which also lists 10 linked publications.

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 8 Jul 2019.

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