Prospective Validation of Cough, Dyspnea, and Quality of Life Questionnaires in Patients With Idiopathic Pulmonary Fibrosis (IPF)
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Pulmonary |
| Therapuetic Areas: | Oncology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | June 2013 |
| End Date: | September 2015 |
| Contact: | Susan S Jacobs, RN, MS |
| Email: | ssjpulm@stanford.edu |
The purpose of this study is to test cough, dyspnea (shortness of breath), and quality of
life (QOL) questionnaires for their accuracy, sensitivity, and ability to reliably measure
the severity of cough, breathlessness, and changes in cough and disease-related quality of
life over time in Idiopathic Pulmonary Fibrosis (IPF) patients. These questionnaires have
been used in other types of disease, but have not all been tested and validated in patients
with cough due to IPF. Our hypothesis is that worsening of cough, dyspnea, and cough-related
QOL questionnaire scores will correlate with physiologic markers of IPF severity and
worsening of disease. Written, valid questionnaires measuring cough, dyspnea, and QOL are
important to assess the benefit of investigational drugs under development to treat patients
with IPF.
life (QOL) questionnaires for their accuracy, sensitivity, and ability to reliably measure
the severity of cough, breathlessness, and changes in cough and disease-related quality of
life over time in Idiopathic Pulmonary Fibrosis (IPF) patients. These questionnaires have
been used in other types of disease, but have not all been tested and validated in patients
with cough due to IPF. Our hypothesis is that worsening of cough, dyspnea, and cough-related
QOL questionnaire scores will correlate with physiologic markers of IPF severity and
worsening of disease. Written, valid questionnaires measuring cough, dyspnea, and QOL are
important to assess the benefit of investigational drugs under development to treat patients
with IPF.
This study in patients with IPF will determine the validity, responsiveness, and reliability
of two cough measures (the Leicester Cough Questionnaire (LCQ), as well as Visual Analogue
Scales (VASs) for cough severity and distress; one dyspnea measure (the Baseline and
Transition Dyspnea Index (BDI/TDI); and two health-related quality of life (HRQL) measures
(the obstructive lung disease-specific Saint George's Respiratory Questionnaire (SGRQ) and
the IPF-specific 'A Tool to Assess QOL in IPF' (ATAQ-IPF). Both the SGRQ and ATAQ include
cough questions. Study participants will complete all questionnaires at baseline, 6, 12, and
18 months at the time of their usual clinic visits. Physiologic data will be collected at
the same time of these visits including pulmonary function testing, exercise oxygen
saturation, and changes in medications and health status. Changes in cough, dyspnea and QOL
scores will be correlated with concurrent changes in physiologic markers of IPF severity. If
a study participant has an acute worsening of their IPF, or undergoes lung transplantation,
study questionnaires may be given at these additional timepoints when possible.
of two cough measures (the Leicester Cough Questionnaire (LCQ), as well as Visual Analogue
Scales (VASs) for cough severity and distress; one dyspnea measure (the Baseline and
Transition Dyspnea Index (BDI/TDI); and two health-related quality of life (HRQL) measures
(the obstructive lung disease-specific Saint George's Respiratory Questionnaire (SGRQ) and
the IPF-specific 'A Tool to Assess QOL in IPF' (ATAQ-IPF). Both the SGRQ and ATAQ include
cough questions. Study participants will complete all questionnaires at baseline, 6, 12, and
18 months at the time of their usual clinic visits. Physiologic data will be collected at
the same time of these visits including pulmonary function testing, exercise oxygen
saturation, and changes in medications and health status. Changes in cough, dyspnea and QOL
scores will be correlated with concurrent changes in physiologic markers of IPF severity. If
a study participant has an acute worsening of their IPF, or undergoes lung transplantation,
study questionnaires may be given at these additional timepoints when possible.
Inclusion Criteria:
- Completion of informed consent.
- Adults over the age of 18.
- Diagnosis of IPF per ATS guidelines.
- Clinically stable at the time of enrollment defined as no antibiotics within the past
month, with the exception of those patients currently listed for Lung
Transplantation.
- No changes in immunosuppressive regimens (if applicable) over past month.
Exclusion Criteria:
- Inability to understand or complete paper and pencil questionnaires.
- Patient not planning to return to Stanford for clinic visits.
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