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Studies

Interventional Recruiting

NCT06882265 on ClinicalTrials.gov

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

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

  • Sponsor: University of Sao Paulo General Hospital
  • Collaborators: Air Liquide SA
  • Enrollment: 60 (Estimated)
  • Study start: 2024-11-10 (Actual)
  • Primary completion: 2025-07-30 (Estimated)
  • Study completion: 2025-12-15 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Double (Investigator, Outcomes Assessor)
  • PrimaryPurpose: Supportive Care

Brief Summary

Assess quality of life of patients using prolonged oxygen therapy

Conditions

  • ILD
  • COPD

Intervention / Treatment

  • Behavioral: Group Monitoring
  • Behavioral: Control Group

Primary Outcome Measures

  • Health-related quality of life (HRQOL): assessed using the EQ-5D-5L Questionnaire (Change from baseline in 30 days over 90 days)
    The EQ-5D-5L questionnaire is a preference-based measure of HRQL with one question for each of five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The responses provided allow for 243 unique health states or can be converted into EQ-5D indices and utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a score ranging from 0 (the worst possible health state) to 100 (the best possible health state).

Countries

Brazil

Locations and Investigators

  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP),, São Paulo, Brazil (Recruiting)
    • Celso RF Carvalho, PhD