Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06290635 |
| Other study ID # |
Pro00119668 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 11, 2022 |
| Est. completion date |
December 30, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
University of Alberta |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Breathlessness is a common problem for many patients with Interstitial lung disease (ILD).
ILD is a group of lung diseases that cause inflammation (swelling) and scarring in the lung
tissue where gas exchange (oxygen and carbon dioxide) occurs. Unfortunately, there is no cure
for these conditions and as a result many patients decline over time with worsening
breathlessness. This limits their ability to live a good life. Clinicians do not often
recognize, assess, or treat breathlessness appropriately. Breathlessness, being a subjective
experience, cannot be fully understood through objective measurements such as lung function
tests, the arterial blood gas test etc. The objective and subjective measures of
breathlessness are frequently disconnected. Clinicians who often rely on these types of
objective tests do not directly enquire into its nature and severity of breathlessness from
patients themselves. As a result, they remain unaware of this disabling symptom and the
extent of its impact on patients. While there are many tools to measure breathlessness, they
are not consistently used in routine care or have impacted care in a meaningful way. Many
such tools are also complex with intricate response systems with possibility of errors and
user fatigue. As a result, easy to use tools like modified MRC or MRC are frequently used
even though they do not assess severity of breathlessness. No tool has been effective at
helping clinicians identify the problem and prescribe appropriate treatments. This results in
needless suffering for patients and their families and prevents them from receiving timely
and appropriate therapies. Investigators propose to test an easy-to-use tool that combines
the subjective and objective aspects of breathlessness. Investigators hope that the tool will
help clinicians quickly identify the patient's breathlessness severity and provide them with
an algorithm of what to do next. The tool was developed by clinicians with +15 years of
experience in ILD and dyspnea. Early analysis already suggests the tool is useful to patients
and helps improve care.
Description:
Dyspnea or breathlessness is a disabling and distressing symptom that affects every aspect of
a patient and caregiver's life. It is prevalent in progressive pulmonary fibrosis (PPF) as
well as many other fibrotic ILD (F-ILD). Idiopathic pulmonary fibrosis (IPF), the most common
and well-studied F-ILD with a life expectancy of only 3-4 years, has a dyspnea prevalence of
90% at diagnosis. Despite the high dyspnea burden in IPF and PPF and its' impact on both
health-related quality of life (HRQOL) and mortality, healthcare professionals often do not
adequately assess or treat dyspnea in practice. Many reasons have been proposed for this care
gap.
Dyspnea is a subjective and complex symptom where experience is shaped by a variety of
factors, including physiological, psychological, and environmental influences. Degree of lung
function impairment does not consistently predict level of breathlessness and cannot be used
as a surrogate for direct dyspnea measures. Unfortunately, dyspnea is not frequently assessed
in care. Many scales exist including uni- and multidimensional scales. MRC, a unidimensional
scale, is the most commonly used dyspnea scale. The MRC scale assesses dyspnea by asking
which activities, ranging from vigorous exercise to minimal activities of daily living, are
limited by dyspnea. The MRC scale has shown good utility in many studies. A major drawback of
the MRC scale in some populations is the lack of a scale point for patients who experience
dyspnea at rest, but it is easy to extend the scale to ask about dyspnea at rest. However,
scales such as the MRC are indirect; they do not actually ask the patient how much dyspnea
they experience. Experts have therefore recommended that patients not only be routinely asked
about dyspnea but should also be asked to rate its severity. In a recent study of over 67000
patients, dyspnea severity reported by patients during a rapid nursing assessment on
admission was associated with two-fold odds of death in 2 years. The authors noted that
patients who reported any dyspnea were at an increased risk of death during that hospital
stay, the greater the dyspnea severity, the greater the risk of death. Even after adjustment
for patient comorbidities, demographics, and severity of illness, increasing dyspnea severity
remained associated with inpatient mortality. They suggest that routine assessment of dyspnea
severity may allow for better monitoring and optimal interventions that could potentially
reduce mortality and morbidity. A 2015 survey of US-based hospitalists also suggests that
dyspnea severity may help guide management. Unfortunately, routine dyspnea severity
assessment is also uncommon in practice.
Secondly there are no dyspnea treatment algorithms for clinicians to implement in practice.
The American Thoracic Society (ATS) statements and guidelines emphasize the urgent need to
assess and manage dyspnea in respiratory disease, including IPF but do not provide a
treatment algorithm. They do recommend evidence-based therapies such as pulmonary
rehabilitation, anxiolytics and opioids and the treatment of associated psychosocial factors.
And finally, physician perspectives regarding dyspnea and reluctance to use opiates,
inadequate education and lack of training are all important barriers to effective dyspnea
management.
To address this care gap in assessment, investigator developed an easy-to-use scale, Edmonton
Dyspnea Inventory (EDI) in the Multidisciplinary Collaborative ILD Clinic, Edmonton, Canada.
EDI is a pilot tool to assess dyspnea severity at rest, during activities of daily living and
self-reported exercise. In addition, the tool also documents crisis dyspnea episodes and
their triggers to guide management. Investigator's preliminary work showed that EDI has good
internal consistency, strong correlation with MRC and weak correlation with lung function
data. Group based trajectory modelling showed 3 different groups of dyspnea intensity with
implications for survival. Investigator also showed feasibility of outpatient clinical use
over 10 years. In addition, EDI use led to early institution of dyspnea therapies (van Den
Bosch AJHPC 2023). This tool facilitated early and personalized dyspnea management that
differs both between and within individual MRC grades (Kalluri. AJHPC 2024). Investigator has
also shown this approach to dyspnea assessment and management facilitates patient
self-management and mastery, allowing reduction in acute care utilization and healthcare
costs in IPF. This is the only tool to that facilitates both assessment and management of
dyspnea. Systematic assessment and appropriate dyspnea management is an urgent unmet need in
patient care. Physicians and clinicians require an easy-to-use tool to assess dyspnea and
create a personalized management plan for their patients. Investigator believes EDI can serve
both purposes as per our early studies. Investigator proposes to examine EDI's
cross-sectional and longitudinal validity and reliability for use in IPF and F-ILD including
PPF. Investigator will also explore patient and care provider perceptions on the use of EDI
and its potential/actual impact on clinical care using focus group methodology. Investigator
will recruit participants from all three sites for qualitative analysis.
