Clinical Impact of HOME Oxygen SATURation Measurement (SATURHOME)
NCT ID: NCT04624191
Last Updated: 2021-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2020-11-11
2023-06-30
Brief Summary
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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.
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Detailed Description
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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)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Intervention Group
Intervention group participants will be asked to measure their oxygen saturation on a daily basis.
Saturation at home
Clinical benefit of taking saturation at home in interstitial lung disease
Control Group
Usual Care
No interventions assigned to this group
Interventions
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Saturation at home
Clinical benefit of taking saturation at home in interstitial lung disease
Eligibility Criteria
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Inclusion Criteria
* Saturation below 90% during the 6-minute walk test
* Clinically stable
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Fondation IUCPQ
OTHER
Laval University
OTHER
Responsible Party
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Geneviève Dion
Principal Investigator
Principal Investigators
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Geneviève Dion, MD
Role: PRINCIPAL_INVESTIGATOR
Institut universitaire de pneumologie et cardiologue de Québec - ULaval
Locations
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Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec
Québec, , Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-3417
Identifier Type: -
Identifier Source: org_study_id
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