Edmonton Dyspnea Inventory- Validation Study

NCT06290635 | Completed

• 1 other identifier: Pro00119668
• Study Type: observational
• Target: 79
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

ILD

Keywords

ILD, Dyspnea, symptoms

Outcome Measures

Primary Outcomes (1)

• Validate Edmonton Dyspnea Inventory (EDI; formerly known as multidimensional dyspnea scale-MDDS)

  Several validity and reliability analyses will be conducted in a cohort of IPF and F-ILD patients (concurrent or face validity); Scale consists of 9 questions that yield a total score between 0-90 with higher scores indicating worse breathlessness

  6 months

Secondary Outcomes (4)

• To perform time-motion observation of care providers or patients using the scale

  1

• Calculate MCID for Edmonton Dyspnea Inventory

  6 months

• Feasibility of Questionnaire

  6 months

• To assess day-to-day variability in dyspnea scores

  1 week

Study Arms (1)

All Participants

Participants include IPF and F-ILD including progressive pulmonary fibrosis phenotype

Diagnostic Test: Breathlessness Assessment Tool

Interventions

Breathlessness Assessment Tool DIAGNOSTIC_TEST

Participants will complete a breathlessness assessment tool (questionnaire) at three timepoints over the study duration, among other validated questionnaires.

All Participants

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ILD patients with age \> 18 yrs with diagnosis confirmed by ILD experts and included IPF, PPF or F-ILD

You may qualify if:

• Adult patients with a guideline-based diagnosis of IPF and any fibrotic ILD including progressive pulmonary fibrosis (PPR).
• As IPF is male dominant disease with most cases presenting late, we need to ensure that females and milder dyspnea grades (MRC 1-2) are also represented in the sample. Dyspnea perception is expected to be higher in females. To ensure representative sampling, we will use a sampling frame at 50% enrolment (50 patients) to ensure at least 25% females and smaller dyspnea grade are included at that point. If not, recruitment will be modified to achieve this.

You may not qualify if:

• Participants unable to consent or understand English or Danish will be excluded as we do not have a version of the scale translated in other languages.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (3)

Kaye Edmonton Clinic

Edmonton, Alberta, T6G 2G3, Canada

Location

Aarhus University

Aarhus, Denmark

Location

Bristol ILD Service; North Bristol NHS Trust

Bristol, United Kingdom

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 4, 2024
• Study Start: November 11, 2022
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); DK (1); GB (1)