Objective Evaluation of the Number of Use Hour of Oxygen Therapy in Patients Receiving Supplemental Oxygen

Not Applicable

• Conditions: Chronic Respiratory Failure With Hypoxia; Chronic Obstructive Pulmonary Disease
• Interventions: Behavioral: Presentation of the adherence record

• Registration Number: NCT04204031
• Lead Sponsor: Haute Ecole de Santé Vaud

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.

Study Timeline

• Status Verified: 2019-12
• Study First Submitted: 2019-12-17
• Study First Submitted QC: 2019-12-17
• Last Update Submitted: 2019-12-17
• Study First Posted: 2019-12-18
• Last Update Posted: 2019-12-18
• Study Start: 2020-01-02
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Presentation of the adherence record	Presentation of the adherence record	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.

Primary Outcome Measures

Name	Time	Method
Oxygen use time	15 days	Average oxygen use time (hours/day) measured with a TeleOx device

Trial Locations

Locations (1)

Haute Ecole de Santé Vaud (HESAV); 🇨🇭 Lausanne, Switzerland