Clinical Impact of HOME Oxygen SATURation Measurement (SATURHOME)

NCT ID: NCT04624191

Last Updated: 2021-10-07

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-11

Study Completion Date

2023-06-30

Brief Summary

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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

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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)

Conditions

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Interstitial Lung Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention Group

Intervention group participants will be asked to measure their oxygen saturation on a daily basis.

Group Type EXPERIMENTAL

Saturation at home

Intervention Type OTHER

Clinical benefit of taking saturation at home in interstitial lung disease

Control Group

Usual Care

Group Type NO_INTERVENTION

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Oxygen dependent at rest
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation IUCPQ

OTHER

Sponsor Role collaborator

Laval University

OTHER

Sponsor Role lead

Responsible Party

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Geneviève Dion

Principal Investigator

Responsibility Role 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

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Geneviève Dion

Role: CONTACT

Jany Harvey, M.Sc.

Role: CONTACT

418-656-8711 ext. 5882

Facility Contacts

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Geneviève Dion, M.D. FRCPC

Role: primary

418-656-8711 ext. 5511

Jany Harvey, M.Sc.

Role: backup

418-656-8711 ext. 5882

Other Identifiers

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2021-3417

Identifier Type: -

Identifier Source: org_study_id

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