NCT04624191

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

November 11, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

October 7, 2021

Status Verified

September 1, 2021

Enrollment Period

2.1 years

First QC Date

September 18, 2020

Last Update Submit

September 29, 2021

Conditions

Interstitial Lung Disease

Keywords

Saturometry at homeQuality of lifeHeath care usePhysical activity level

Outcome Measures

Primary Outcomes (1)

  • Quality of life by questionnaire

    Impact of home base saturometry on quality of life

    1 year

Secondary Outcomes (5)

  • 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

Other Outcomes (3)

  • Acute exacerbation

    1 year

  • Pulmonary function decline

    1 year

  • Mortality

    1 year

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Other: Saturation at home

Control Group

NO INTERVENTION

Usual Care

Interventions

Saturation at homeOTHER

Clinical benefit of taking saturation at home in interstitial lung disease

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Oxygen dependent at rest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec

Québec, G1V 4G5, Canada

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Geneviève Dion, MD

    Institut universitaire de pneumologie et cardiologue de Québec - ULaval

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Geneviève Dion

CONTACT

418-656-8711geneviève.dion@criucpq.ulaval.ca

Jany Harvey, M.Sc.

CONTACT

418-656-8711jany.harvey@criucpq.ulaval.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 18, 2020

First Posted

November 10, 2020

Study Start

November 11, 2020

Primary Completion

December 30, 2022

Study Completion

June 30, 2023

Last Updated

October 7, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)