NCT04204031

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™)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

January 2, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

December 18, 2019

Status Verified

December 1, 2019

Enrollment Period

9 months

First QC Date

December 17, 2019

Last Update Submit

December 17, 2019

Conditions

Keywords

Long term oxygen therapyadherenceelectronic monitoring

Outcome Measures

Primary Outcomes (1)

  • Oxygen use time

    Average oxygen use time (hours/day) measured with a TeleOx device

    15 days

Study Arms (1)

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.

Behavioral: Presentation of the adherence record

Interventions

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.

Presentation of the adherence record

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Oxygen prescription for at least 15 hours/day

You may not qualify if:

  • under 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haute Ecole de Santé Vaud (HESAV)

Lausanne, 1011, Switzerland

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Olivier Contal, PhD

    Haute Ecole de Santé Vaud

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier Contal, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ordinary Professor HES

Study Record Dates

First Submitted

December 17, 2019

First Posted

December 18, 2019

Study Start

January 2, 2020

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

December 18, 2019

Record last verified: 2019-12

Locations