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Clinical Trials/NCT04624191
NCT04624191UnknownNot Applicable

Clinical Impact of Home Oxygen Saturation Measurement in Patients With Interstitial Lung Disease: Quality of Live, Health Care Use, Score of Anxiety, Depression and Dyspnea and Physical Activity Level

Laval University2 sites in 1 country100 target enrollmentStarted: November 11, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Locations
2
Primary Endpoint
Quality of life by questionnaire

Study Overview

Brief Summary

The use of saturometry at home is more and more widespread in patients suffering from interstitial pulmonary diseases (IPD), the patients seeing it as reassurance and a concrete way to follow the evolution of their disease. However, there are no studies evaluating the real clinical benefit of taking saturation at home in this population. In addition, clinical experience seems rather to demonstrate an increase in the anxiety level and the number of clinically unnecessary consultations related to the use of this measure.

The secondary objectives are to determine the impact of this measurement on: (1) the health care use (telephone calls, medical consultations and hospitalizations), (2) dyspnea score, (3) the anxiety and depression score (HADS score) and (4) the physical activity level. The exploratory objectives will be to determine if the measurement of saturation at home makes it possible to (1) predict the occurrence of acute exacerbations of fibrosis, (2) effectively predict the decline in respiratory function tests and (3) 1-year mortality. The investigator will also assess whether this measure makes it possible to screen patients with oxygen therapy needs at home. The investigator hypothesize that measuring oxygen saturation at home will lead to a significant deterioration in quality of life, an increase in the use of health care, a significant increase in the rate of anxiety and depression, dyspnea and a decrease in the physical activity level.

Detailed Description

Measurement tools

  1. Quality of life: King's Brief Interstitial Lung Disease
  2. Anxiety and depression score: HADS score
  3. Dyspnea score : UCSD questionnaire
  4. Physical activity level during 7 days: MoveMonitor by McRoberts
  5. Home base saturation: Nonin Ny vantagr 9590
  6. Disease evolution : complete lung function (plethymography, sprimoetry, DLCO), 6-minute walking test (following the ATS recommandation)

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Fibrosing interstitial lung disease
  • Saturation below 90% during the 6-minute walk test
  • Clinically stable

Exclusion Criteria

  • Oxygen dependent at rest

Outcomes

Primary Outcomes

Quality of life by questionnaire

Time Frame: 1 year

Impact of home base saturometry on quality of life

Secondary Outcomes

  • Health care use (phone calls, medical consultation)(1 year)
  • Dyspnea score(1 year)
  • Anxiety and depression score(1 year)
  • Physical activity level(1 year)
  • Energy expenditure(1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Geneviève Dion

Principal Investigator

Laval University

Study Sites (2)

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