Impact of Remote Vital Signs Monitoring in People Using Long-term Oxygen Therapy
NCT ID: NCT06882265
Last Updated: 2025-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-11-10
2025-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Group Monitoring
After randomization, participants in the GM group will receive the Venu® SQ monitor (Garmin). All participants will receive guidance on how to use the ODI in the educational class, and at the end they will receive specific instructions for use of the devices they will receive (wearable monitor or pulse oximeter). After the first visit, GM participants will be contacted biweekly by telephone to obtain information on their clinical progress, where they will be asked about the number of exacerbations, respiratory symptoms, medication adherence, time of O2 use, and dyspnea symptoms (mMRC). Likewise, monthly contact will be made to obtain information on health factors associated with quality of life (K-BILD), CAT and EQ-5D-5L, and symptoms of anxiety and depression (HADS).
Group Monitoring
In the intervention group (IG), participants receive a HR and SPO2 monitor watch and a pulse oximeter and will be monitored every 15 days by a nurse to check for non-adherence and/or technical failure, and/or exacerbations, and monthly to apply questionnaires.
Control Group
For the GC, contact will only be monthly to obtain all the information mentioned above in addition to the HR and SpO2 measurements taken on the day of the telephone application.
Control Group
In the control group (CG), participants receive only a pulse oximeter and will be monitored monthly by a nurse to administer the questionnaires.
Interventions
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Group Monitoring
In the intervention group (IG), participants receive a HR and SPO2 monitor watch and a pulse oximeter and will be monitored every 15 days by a nurse to check for non-adherence and/or technical failure, and/or exacerbations, and monthly to apply questionnaires.
Control Group
In the control group (CG), participants receive only a pulse oximeter and will be monitored monthly by a nurse to administer the questionnaires.
Eligibility Criteria
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Inclusion Criteria
* Age over 18 years;
* Clinical stability (absence of exacerbations or hospitalizations related to the underlying disease) for at least 6 weeks;
* Patients who are on optimized drug therapy, including long-term home oxygen therapy (LTOT)
* Have a smartphone compatible with the monitoring device;
* Signing of the ICF to participate in the study.
Exclusion Criteria
* Myocardial infarction within four months prior to the start of the study, unstable angina or severe heart disease (NYHA functional class III-IV) and/or decompensated.
* Patients who received a lung transplant during the study
* Living outside the coverage area or moving out of state
18 Years
85 Years
ALL
No
Sponsors
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Air Liquide SA
INDUSTRY
University of Sao Paulo General Hospital
OTHER
Responsible Party
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Locations
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Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP),
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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68384723900000068
Identifier Type: -
Identifier Source: org_study_id
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