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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03480451
Acronym
IPF
Enrollment
1
Registered
2018-03-29
Start date
2017-09-12
Completion date
2019-02-01
Last updated
2019-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis

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.

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.

Interventions

OTHERMulti-Disciplinary Patient Centered Rehab and Education

This project is being withdrawn.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

Sponsors

Medical College of Wisconsin
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assess the change in coping skills for patients with IPF before and after a comprehensive pulmonary rehabilitation program.12 monthsThis project is being withdrawn. No revisions to Outcomes is available. Will use COPE questionnaire.
Assess the change in quality of life for patients with IPF before and after a comprehensive pulmonary rehabilitation program.12 monthsWill use 36-item SF questionnaire.
Assess the change in depression, anxiety for patients with IPF before and after a comprehensive pulmonary rehabilitation program.12 monthsWill use DASS-21 questionnaire.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026