RecruitingNot ApplicableNCT06882265

Impact of Remote Vital Signs Monitoring in People Using Long-term Oxygen Therapy

Impact of Remote Vital Signs Monitoring in People Using Long-term Oxygen Therapy : a Randomized Clinical Trial


Sponsor

University of Sao Paulo General Hospital

Enrollment

60 participants

Start Date

Nov 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Assess quality of life of patients using prolonged oxygen therapy


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria6

  • 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 Criteria4

  • 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

Interventions

BEHAVIORALGroup 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.

BEHAVIORALControl Group

In the control group (CG), participants receive only a pulse oximeter and will be monitored monthly by a nurse to administer the questionnaires.


Locations(1)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP),

São Paulo, São Paulo, Brazil

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NCT06882265


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