Impact of Remote Vital Signs Monitoring in People Using Long-term Oxygen Therapy (ILD; COPD)

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

Assess quality of life of patients using prolonged oxygen therapy

Study Overview

• Status: Recruiting
• Conditions: COPD; ILD
• Intervention / Treatment: Behavioral: Group Monitoring; Behavioral: Control Group

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Celso RF Carval, Diretor do Estudo; Phone Number: 55 11 98415-3234; Email: cscarval@usp.br

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05360-160
      • Recruiting
      • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP),
      • Contact: Celso RF Carvalho, PhD; Phone Number: 55 11 98415-3234; Email: cscarval@usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life (HRQOL): assessed using the EQ-5D-5L Questionnaire	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).	Change from baseline in 30 days over 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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)	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 from baseline in 30 days over 90 days
Change in psychosocial symptoms	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 from baseline in 30 days over 90 days
Change in dyspnea	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.	Change from baseline in 30 days over 90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	Evaluated according to the data included in the application and responses to questionnaires.	Baseline
Exarcebations	Assessed through changes or alterations in vital signs of heart rate and/or oxygen saturation through the wearable	Baseline
Função pulmonar	Lung volumes will be assessed by spirometry	Baseline

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: Air Liquide SA

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2024
• Primary Completion (Estimated): July 30, 2025
• Study Completion (Estimated): December 15, 2025

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: COPD; Quality of life; ILD; Monitoring remote
• Other Study ID Numbers: 68384723900000068

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No