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

NCT ID: NCT04204031

Last Updated: 2019-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-02

Study Completion Date

2020-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Respiratory Failure With Hypoxia Chronic Obstructive Pulmonary Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Long term oxygen therapy adherence electronic monitoring

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

Presentation of the adherence record

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Geneva

OTHER

Sponsor Role collaborator

Ligue Pulmonaire Genevoise

OTHER

Sponsor Role collaborator

Haute Ecole de Santé Vaud

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Olivier Contal

Ordinary Professor HES

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Olivier Contal, PhD

Role: PRINCIPAL_INVESTIGATOR

Haute Ecole de Santé Vaud

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Haute Ecole de Santé Vaud (HESAV)

Lausanne, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Olivier Contal, PhD

Role: CONTACT

Phone: +41213168122

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Olivier Contal, PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-01954

Identifier Type: -

Identifier Source: org_study_id