Chronic Respiratory Failure With HypoxiaMONOXNCT04204031
Objective Evaluation of the Number of Use Hour of Oxygen Therapy in Patients Receiving Supplemental Oxygen
A study testing Presentation of the adherence record in people with Chronic Respiratory Failure With Hypoxia and Chronic Obstructive Pulmonary Disease, run by Haute Ecole de Santé Vaud at 1 site in Switzerland.
Trial summary
The aim of this study is to measure the actual use time in patients receiving supplemental oxygen using a new easy-to-use electronic remote monitoring device (TeleOx™) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Respiratory Failure With Hypoxia, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Presentation of the adherence record
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Jan 2020to 30 Sep 2020
- 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
- Long term oxygeno-therapy patients in stable condition without pulmonary exacerbation in the month before inclusion
- Oxygen prescription for at least 15 hours/day
Who cannot join
- under 18 years old
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Haute Ecole de Santé Vaud (HESAV)
Lausanne, 1011
Olivier Contal, PhD, +41213168122, olivier.contal@hesav.ch
Nils Correvon, MSc
About this study
The aim of this study is to measure the actual use time in patients receiving supplemental oxygen using a new easy-to-use electronic remote monitoring device (TeleOx™)
Read the detailed description
The first phase of the study is observational. Oxygen use time of patients with chronic respiratory failure under long term oxygen therapy will be objectively measured using a electronic remote monitoring device (TeleOx™) over 15 days. The actual use time will be compared to their oxygen prescription.
Participants whose actual time of use will be less than prescribed will be offered an intervention which will consist of a presentation of the adherence record. The participant will also be asked about the presence of possible barriers concerning the use of oxygen therapy. The collaborator in charge of home visits will attempt to resolve these barriers as much as possible. Only participants with an actual time of use less than prescribed will be offered this intervention and will continue the monitoring over a period of 15 additional days.
- Being tested
- Presentation of the adherence record
- Keywords
- Long term oxygen therapy, adherence, electronic monitoring
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Presentation of the adherence recordBehavioural
Adherence record will be presented to participants with an actual time of use less than prescribed. The participant will also be asked about the presence of possible barriers concerning the use of oxygen therapy. The collaborator in charge of home visits will attempt to resolve these barriers as much as possible.
| Study group | Role | What they receive |
|---|---|---|
| Presentation of the adherence record | Other | Following a first observation period of 15 days, participants whose actual time of use will be less than prescribed will be offered an intervention which will consist of a presentation of the adherence record. The participant will also be asked about the presence of possible barriers concerning the use of oxygen therapy. The collaborator in charge of home visits will attempt to resolve these barriers as much as possible.
Only participants with an actual time of use less than prescribed will be offered this intervention and will continue the monitoring over a period of 15 additional days. Receives: Behavioral: Presentation of the adherence record |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen use time
Average oxygen use time (hours/day) measured with a TeleOx device
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start2 Jan 2020 (estimated)
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Respiratory Failure With HypoxiaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haute Ecole de Santé Vaud
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva, Ligue Pulmonaire Genevoise
- Responsible party
- Principal investigator, Olivier Contal, Haute Ecole de Santé Vaud
- Investigators
- Olivier Contal, PhD, Principal investigator, Haute Ecole de Santé Vaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204031
- Sponsor's protocol ID
- 2019-01954
- Other IDs
- 2019
- Acronym
- MONOX
- Status last verified
- Dec 2019
- First submitted
- 17 Dec 2019
- Last updated
- 18 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Evaluation of the Number of Use Hour of Oxygen Therapy in Patients Receiving Supplemental Oxygen
- ClinicalTrials.gov ID
- NCT04204031
- Acronym / sponsor ID
- MONOX / 2019-01954
- Keywords
- Long term oxygen therapy, adherence, electronic monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Haute Ecole de Santé VaudUniversity, hospital or other
- Collaborators
- University Hospital, Geneva, Ligue Pulmonaire Genevoise
- Study start
- 2 Jan 2020 (estimated)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 18 Dec 2019 (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 aim of this study is to measure the actual use time in patients receiving supplemental oxygen using a new easy-to-use electronic remote monitoring device (TeleOx™)
Detailed description
The first phase of the study is observational. Oxygen use time of patients with chronic respiratory failure under long term oxygen therapy will be objectively measured using a electronic remote monitoring device (TeleOx™) over 15 days. The actual use time will be compared to their oxygen prescription.
Participants whose actual time of use will be less than prescribed will be offered an intervention which will consist of a presentation of the adherence record. The participant will also be asked about the presence of possible barriers concerning the use of oxygen therapy. The collaborator in charge of home visits will attempt to resolve these barriers as much as possible. Only participants with an actual time of use less than prescribed will be offered this intervention and will continue the monitoring over a period of 15 additional days.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Presentation of the adherence record | Other | Behavioral: Presentation of the adherence recordFollowing a first observation period of 15 days, participants whose actual time of use will be less than prescribed will be offered an intervention which will consist of a presentation of the adherence record. The participant will also be asked about the presence of possible barriers concerning the use of oxygen therapy. The collaborator in charge of home visits will attempt to resolve these barriers as much as possible. Only participants with an actual time of use less than prescribed will be offered this intervention and will continue the monitoring over a period of 15 additional days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Long term oxygeno-therapy patients in stable condition without pulmonary exacerbation in the month before inclusion
- Oxygen prescription for at least 15 hours/day
Key exclusion criteria (1 listed)
- under 18 years old
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 |
|---|---|---|
| Presentation of the adherence recordAdherence record will be presented to participants with an actual time of use less than prescribed. The participant will also be asked about the presence of possible barriers concerning the use of oxygen therapy. The collaborator in charge of home visits will attempt to resolve these barriers as much as possible. | Behavioural | Presentation of the adherence record |
Primary outcome
Oxygen use time
Time frame: 15 days
Average oxygen use time (hours/day) measured with a TeleOx device
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
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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.
Olivier Contal, PhD principal investigator
Haute Ecole de Santé Vaud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Presentation of the adherence record in people with Chronic Respiratory Failure With Hypoxia and Chronic Obstructive Pulmonary Disease, run by Haute Ecole de Santé Vaud at 1 site in Switzerland.
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 2 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 18 Dec 2019. 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 Switzerland. 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 Olivier Contal, PhD (+41213168122, olivier.contal@hesav.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen use time (time frame: 15 days). 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 18 Dec 2019.