Interstitial Lung DiseaseSATURHOMENCT04624191
Clinical Impact of HOME Oxygen SATURation Measurement (SATURHOME)
A study testing Saturation at home in people with Interstitial Lung Disease, run by Laval University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- Saturation at home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 11 Nov 2020to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fibrosing interstitial lung disease
- Saturation below 90% during the 6-minute walk test
- Clinically stable
Who cannot join
- Oxygen dependent at rest
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec
Québec, G1V 4G5
Geneviève Dion, M.D. FRCPC, 418-656-8711 ext. 5511, genevieve.dion@criucpq.ulaval.ca
Jany Harvey, M.Sc., 418-656-8711 ext. 5882, jany.harvey@criucpq.ulaval.ca
About this study
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
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.
Read the 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)
- Conditions
- Interstitial Lung Disease
- Being tested
- Saturation at home
- Keywords
- Saturometry at home, Quality of life, Heath care use, Physical activity level
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saturation at homeOther
Clinical benefit of taking saturation at home in interstitial lung disease
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Intervention group participants will be asked to measure their oxygen saturation on a daily basis. Receives: Other: Saturation at home |
| Control Group | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life by questionnaire
Impact of home base saturometry on quality of life
Measured: 1 year
Secondary outcomes (5)
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.
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
Physical activity level
Impact of home base saturometry on physical activity level measure by accelerometer (McRoberts) and define by steps number.
Measured: 1 year
Energy expenditure
Impact of home base saturometry on energy expenditure (number of kilocalories burn by day), measure by accelerometer (McRoberts).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start11 Nov 2020
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation IUCPQ
- Responsible party
- Principal investigator, Geneviève Dion, Laval University
- Investigators
- Geneviève Dion, MD, Principal investigator, Institut universitaire de pneumologie et cardiologue de Québec - ULaval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624191
- Sponsor's protocol ID
- 2021-3417
- Acronym
- SATURHOME
- Status last verified
- Sep 2021
- First submitted
- 18 Sep 2020
- Last updated
- 7 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04624191
- Acronym / sponsor ID
- SATURHOME / 2021-3417
- Conditions
- Interstitial Lung Disease
- Keywords
- Saturometry at home, Quality of life, Heath care use, Physical activity level
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Fondation IUCPQ
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Saturation at homeIntervention group participants will be asked to measure their oxygen saturation on a daily basis. |
| Control Group | No intervention | –Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fibrosing interstitial lung disease
- Saturation below 90% during the 6-minute walk test
- Clinically stable
Key exclusion criteria (1 listed)
- Oxygen dependent at rest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saturation at homeClinical benefit of taking saturation at home in interstitial lung disease | Other | Intervention Group |
Primary outcome
Quality of life by questionnaire
Time frame: 1 year
Impact of home base saturometry on quality of life
5 secondary outcomes
Health care use (phone calls, medical consultation)
Time frame: 1 year
Dyspnea score
Time frame: 1 year
Anxiety and depression score
Time frame: 1 year
Physical activity level
Time frame: 1 year
Energy expenditure
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geneviève Dion, MD principal investigator
Institut universitaire de pneumologie et cardiologue de Québec - ULaval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saturation at home in people with Interstitial Lung Disease, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Geneviève Dion (418-656-8711, geneviève.dion@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life by questionnaire (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2021.