Back to resultsObjective Evaluation of the Number of Use Hour of Oxygen Therapy in Patients Receiving Supplemental Oxygen (MONOX)
Primary Purpose
Chronic Respiratory Failure With Hypoxia, Chronic Obstructive Pulmonary Disease
Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Presentation of the adherence record
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Respiratory Failure With Hypoxia focused on measuring Long term oxygen therapy, adherence, electronic monitoring
Eligibility Criteria
Inclusion Criteria:
- Long term oxygeno-therapy patients in stable condition without pulmonary exacerbation in the month before inclusion
- Oxygen prescription for at least 15 hours/day
Exclusion Criteria:
- under 18 years old
Sites / Locations
- Haute Ecole de Santé Vaud (HESAV)
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Presentation of the adherence record
Arm Description
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.
Outcomes
Primary Outcome Measures
Oxygen use time
Average oxygen use time (hours/day) measured with a TeleOx device
Secondary Outcome Measures
Full Information
NCT ID
NCT04204031
First Posted
December 17, 2019
Last Updated
December 17, 2019
Sponsor
Haute Ecole de Santé Vaud
Collaborators
University Hospital, Geneva, Ligue Pulmonaire Genevoise
1. Study Identification
Unique Protocol Identification Number
NCT04204031
Brief Title
Objective Evaluation of the Number of Use Hour of Oxygen Therapy in Patients Receiving Supplemental Oxygen
Acronym
MONOX
Official Title
Objective Evaluation of the Number of Use Hour of Oxygen Therapy in Patients Receiving Supplemental Oxygen
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2020 (Anticipated)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Haute Ecole de Santé Vaud
Collaborators
University Hospital, Geneva, Ligue Pulmonaire Genevoise
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Respiratory Failure With Hypoxia, Chronic Obstructive Pulmonary Disease
Keywords
Long term oxygen therapy, adherence, electronic monitoring
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Presentation of the adherence record
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Presentation of the adherence record
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oxygen use time
Description
Average oxygen use time (hours/day) measured with a TeleOx device
Time Frame
15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Long term oxygeno-therapy patients in stable condition without pulmonary exacerbation in the month before inclusion
Oxygen prescription for at least 15 hours/day
Exclusion Criteria:
under 18 years old
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier Contal, PhD
Phone
+41213168122
Email
olivier.contal@hesav.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Contal, PhD
Organizational Affiliation
Haute Ecole de Santé Vaud
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haute Ecole de Santé Vaud (HESAV)
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Contal, PhD
Phone
+41213168122
Email
olivier.contal@hesav.ch
First Name & Middle Initial & Last Name & Degree
Nils Correvon, MSc
12. IPD Sharing Statement
Learn more about this trial
Objective Evaluation of the Number of Use Hour of Oxygen Therapy in Patients Receiving Supplemental Oxygen
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