Clinical Impact of HOME Oxygen SATURation Measurement (SATURHOME) (SATURHOME)
Primary Purpose
Interstitial Lung Disease
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Saturation at home
Sponsored by
About this trial
This is an interventional supportive care trial for Interstitial Lung Disease focused on measuring Saturometry at home, Quality of life, Heath care use, Physical activity level
Eligibility Criteria
Inclusion Criteria:
- Fibrosing interstitial lung disease
- Saturation below 90% during the 6-minute walk test
- Clinically stable
Exclusion Criteria:
- Oxygen dependent at rest
Sites / Locations
- Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de QuébecRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Control Group
Arm Description
Intervention group participants will be asked to measure their oxygen saturation on a daily basis.
Usual Care
Outcomes
Primary Outcome Measures
Quality of life by questionnaire
Impact of home base saturometry on quality of life
Secondary Outcome Measures
Health care use (phone calls, medical consultation)
Impact of home base saturometry on health car use as number and principal reason for : telephone calls, medical consultations and hospitalizations.
Dyspnea score
Impact of home base saturometry on dyspnea score with the University of California, San Diego Shortness of breath Questionnaire (UCSD) in a scale between 0 to 120 where 120 is the worst score.
Anxiety and depression score
Impact of home base saturometry on anxiety and depression score with the Hospital Anxiety and Depression Scale Questionnaire (HADs) in a scale between 0 to 42, where 42 is the worst score.
Physical activity level
Impact of home base saturometry on physical activity level measure by accelerometer (McRoberts) and define by steps number.
Energy expenditure
Impact of home base saturometry on energy expenditure (number of kilocalories burn by day), measure by accelerometer (McRoberts).
Full Information
NCT ID
NCT04624191
First Posted
September 18, 2020
Last Updated
September 29, 2021
Sponsor
Laval University
Collaborators
Fondation IUCPQ
1. Study Identification
Unique Protocol Identification Number
NCT04624191
Brief Title
Clinical Impact of HOME Oxygen SATURation Measurement (SATURHOME)
Acronym
SATURHOME
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 11, 2020 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Fondation IUCPQ
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
Quality of life: King's Brief Interstitial Lung Disease
Anxiety and depression score: HADS score
Dyspnea score : UCSD questionnaire
Physical activity level during 7 days: MoveMonitor by McRoberts
Home base saturation: Nonin Ny vantagr 9590
Disease evolution : complete lung function (plethymography, sprimoetry, DLCO), 6-minute walking test (following the ATS recommandation)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease
Keywords
Saturometry at home, Quality of life, Heath care use, Physical activity level
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Intervention group participants will be asked to measure their oxygen saturation on a daily basis.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Usual Care
Intervention Type
Other
Intervention Name(s)
Saturation at home
Intervention Description
Clinical benefit of taking saturation at home in interstitial lung disease
Primary Outcome Measure Information:
Title
Quality of life by questionnaire
Description
Impact of home base saturometry on quality of life
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Health care use (phone calls, medical consultation)
Description
Impact of home base saturometry on health car use as number and principal reason for : telephone calls, medical consultations and hospitalizations.
Time Frame
1 year
Title
Dyspnea score
Description
Impact of home base saturometry on dyspnea score with the University of California, San Diego Shortness of breath Questionnaire (UCSD) in a scale between 0 to 120 where 120 is the worst score.
Time Frame
1 year
Title
Anxiety and depression score
Description
Impact of home base saturometry on anxiety and depression score with the Hospital Anxiety and Depression Scale Questionnaire (HADs) in a scale between 0 to 42, where 42 is the worst score.
Time Frame
1 year
Title
Physical activity level
Description
Impact of home base saturometry on physical activity level measure by accelerometer (McRoberts) and define by steps number.
Time Frame
1 year
Title
Energy expenditure
Description
Impact of home base saturometry on energy expenditure (number of kilocalories burn by day), measure by accelerometer (McRoberts).
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Acute exacerbation
Description
Impact of home base saturometry on predict the occurrence of acute exacerbations of fibrosis.
Occurence: number of exacerbation of fibrosis during the year.
Time Frame
1 year
Title
Pulmonary function decline
Description
Impact of home base saturometry on predict the decline in respiratory function tests, principally the forced vital capacity.
Time Frame
1 year
Title
Mortality
Description
Impact of home base saturometry on 1-year mortality prediction
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Fibrosing interstitial lung disease
Saturation below 90% during the 6-minute walk test
Clinically stable
Exclusion Criteria:
Oxygen dependent at rest
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geneviève Dion
Phone
418-656-8711
Email
geneviève.dion@criucpq.ulaval.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Jany Harvey, M.Sc.
Phone
418-656-8711
Ext
5882
Email
jany.harvey@criucpq.ulaval.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geneviève Dion, MD
Organizational Affiliation
Institut universitaire de pneumologie et cardiologue de Québec - ULaval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec
City
Québec
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geneviève Dion, M.D. FRCPC
Phone
418-656-8711
Ext
5511
Email
genevieve.dion@criucpq.ulaval.ca
First Name & Middle Initial & Last Name & Degree
Jany Harvey, M.Sc.
Phone
418-656-8711
Ext
5882
Email
jany.harvey@criucpq.ulaval.ca
12. IPD Sharing Statement
Plan to Share IPD
No
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Clinical Impact of HOME Oxygen SATURation Measurement (SATURHOME)
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