NCT03480451

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
terminated

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

December 12, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

September 12, 2017

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

8 months

First QC Date

December 12, 2016

Last Update Submit

July 4, 2019

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (3)

  • 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    This project is being withdrawn.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.

    12 months

  • 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.

    12 months

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

    Will use DASS-21 questionnaire.

    12 months

Study Arms (1)

Single Arm

OTHER

This 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

Other: Multi-Disciplinary Patient Centered Rehab and Education

Interventions

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

Single Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (10)

  • 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.

    PMID: 21471066BACKGROUND

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

    PMID: 18366757BACKGROUND

  • 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.

    PMID: 9445300BACKGROUND

  • 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.

    PMID: 15994268BACKGROUND

  • 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.

    PMID: 27274328BACKGROUND

  • 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.

    PMID: 23851327BACKGROUND

  • 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.

    PMID: 27064659BACKGROUND

  • 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.

    PMID: 18084170BACKGROUND

  • 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.

    PMID: 22421582BACKGROUND

  • 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.

    PMID: 22197576BACKGROUND

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Vijay Ramalingam, MD

    Medical College of WI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

December 12, 2016

First Posted

March 29, 2018

Study Start

September 12, 2017

Primary Completion

May 1, 2018

Study Completion

February 1, 2019

Last Updated

July 8, 2019

Record last verified: 2019-07

Locations

US(1)