Recruiting

SATURHOME

Sponsor:

Laval University

Code:

NCT04624191

Conditions

Interstitial Lung Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Saturation at home

Study Details

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.

Conditions

Interstitial Lung Disease

Study ID

NCT04624191

Start date

Nov 11, 2020

Status verified date

Sep, 2021

Completion date

Jun 30, 2023

Anticipated

Primary completion date

Dec 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Oxygen dependent at rest

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention Group

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

no intervention: Control Group

Usual Care

Interventions

Saturation at home

Clinical benefit of taking saturation at home in interstitial lung disease

Primary outcome measure

  • Quality of life by questionnaire [ Time Frame: 1 year ]

Central Contacts and Locations

Locations

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

Recruiting

Québec, Canada, G1V 4G5

Contacts

More Information

Sponsor

Laval University

Last update posted

Oct 7, 2021

Last verified

Sep, 2021

Keywords

  • Saturometry at home
  • Quality of life
  • Heath care use
  • Physical activity level

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2021-10-07.