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

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ClinicalTrials.gov Identifier: NCT03480451
Recruitment Status : Recruiting
First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Vijaya Ramalingam, Medical College of Wisconsin

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.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Other: Multi-Disciplinary Patient Centered Rehab and Education Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Targeted Intervention for Patient Centered Outcome in Patients With Idiopathic Pulmonary Fibrosis
Actual Study Start Date : September 12, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Single Arm
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
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




Primary Outcome Measures :
  1. Assess the change in coping skills for patients with IPF before and after a comprehensive pulmonary rehabilitation program. [ Time Frame: 12 months ]
    Will use COPE questionnaire.

  2. Assess the change in quality of life for patients with IPF before and after a comprehensive pulmonary rehabilitation program. [ Time Frame: 12 months ]
    Will use 36-item SF questionnaire.

  3. Assess the change in depression, anxiety for patients with IPF before and after a comprehensive pulmonary rehabilitation program. [ Time Frame: 12 months ]
    Will use DASS-21 questionnaire.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480451


Contacts
Contact: Jeanette Graf, BS, CCRP 414-955-7040 jgraf@mcw.edu
Contact: Stephanie Zellner, MS, CCRC 414-955-7040 szellner@mcw.edu

Locations
United States, Wisconsin
Froedtert Memorial Lutheran Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Vijay Ramalingam, MD    414-955-7040      
Contact: Jeanette Graf, CCRP    414-955-6987    lung@mcw.edu   
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: Vijay Ramalingam, MD Medical College of WI

Publications:

Responsible Party: Vijaya Ramalingam, Assistant Professor of Medicine, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT03480451     History of Changes
Other Study ID Numbers: 28280
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial