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

Not Applicable

Recruiting

• Conditions: ILD; COPD

• Registration Number: NCT06882265
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

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.

Study Timeline

• Study Start: 2024-11-10
• Status Verified: 2025-01
• Study First Submitted: 2025-02-18
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-18
• Last Update Posted: 2025-03-18
• Primary Completion: 2025-07-30
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
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.	Change from baseline in 30 days over 90 days	It consists of eight items related to the health condition and is applied and validated worldwide in several scales. The maximum score for the test is 40 points, and the questions cover the following symptoms: cough, phlegm production, chest pressure, shortness of breath, activities of daily living, psychological aspects, sleep and mood. Each question has six options (0-5), and the lower the score, the better the health condition.; 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)	Change from baseline in 30 days over 90 days	The King's Brief Interstitial Lung Disease (K-BILD) questionnaire is a health status questionnaire developed and validated specifically for patients with ILD. It consists of 15 items that measure health status in the last two weeks in three domains (symptoms, resistance, mental health status and dyspnea on exertion), and is easy to administer and understand by patients. Its classification can range from 0 to 100, with a higher score indicating a higher quality of life, and variations of 5 units are already considered clinically significant.
Change in psychosocial symptoms	Change from baseline in 30 days over 90 days	Symptoms of anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADs), which consists of 14 items divided into 2 subscales (7 for anxiety and 7 for depression). Each item is scored from 0 to 3, with a maximum score of 21 points for each subscale. A score greater than 8/9 on each subscale suggests a diagnosis of anxiety and/or depression.
Change in dyspnea	Change from baseline in 30 days over 90 days	Dyspnea scale: modified Medical Research Council (mMRC). The mMRC is a unidirectional 0- to 4-point scale whose questions closely correspond to daily activities that provoke dyspnea.

Trial Locations

Locations (1)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP),; 🇧🇷 São Paulo, SP, Brazil