Impact of Remote Vital Signs Monitoring in People Using Long-term Oxygen Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Group Monitoring, Control Group.
- Who it may be relevant to
- Registry conditions: ILD, COPD. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Remote Vital Signs Monitoring in People Using Long-term Oxygen Therapy : a Randomized Clinical Trial
Overview
Assess quality of life of patients using prolonged oxygen therapy
Detailed description
Adult participants of both sexes with COPD and PID, prolonged oxygen use, will be evaluated after being informed about the study, agreeing and signing the informed consent form. Participants will be randomized to a control group and a group monitored for 90 days. The monitored group will receive a wearable device to monitor vital signs of heart rate and oxygen saturation and the control group will receive a pulse oximeter. Both groups will be monitored through the cell phone application.
Interventions
- Behavioral 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. - Behavioral 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.
Primary outcome measures
- Health-related quality of life (HRQOL): assessed using the EQ-5D-5L Questionnaire [Time frame: Change from baseline in 30 days over 90 days]
Secondary outcome measures (4)
- Clinical Management: The COPD Assessment Test™ (CAT) is a specific questionnaire for COPD that assesses the impact of disease symptoms on quality of life factors in chronic obstructive pulmonary disease. [Time frame: Change from baseline in 30 days over 90 days]
- Changes related to quality of life factors in interstitial lung disease - King's Brief Interstitial Lung Disease (K-BILD) [Time frame: Change from baseline in 30 days over 90 days]
- Change in psychosocial symptoms [Time frame: Change from baseline in 30 days over 90 days]
- Change in dyspnea [Time frame: Change from baseline in 30 days over 90 days]
Eligibility criteria
Inclusion criteria
- Patients with a clinical, radiological and/or anatomopathological diagnosis of COPD and ILD according to the 2020 ATS/JRS/ALAT guidelines;
- 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
- Presence of other concomitant lung diseases;
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Brazil · 1 center
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP), — São Paulo
Identifiers
NCT: NCT06882265 · 68384723900000068