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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04204031
Other study ID # 2019-01954
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 2, 2020
Est. completion date September 30, 2020

Study information

Verified date December 2019
Source Haute Ecole de Santé Vaud
Contact Olivier Contal, PhD
Phone +41213168122
Email olivier.contal@hesav.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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™)


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date September 30, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
Presentation of the adherence record
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.

Locations

Country Name City State
Switzerland Haute Ecole de Santé Vaud (HESAV) Lausanne

Sponsors (3)

Lead Sponsor Collaborator
Haute Ecole de Santé Vaud Ligue Pulmonaire Genevoise, University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Oxygen use time Average oxygen use time (hours/day) measured with a TeleOx device 15 days
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