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

NCT06882265 | Recruiting DMC

• 1 other identifier: 68384723900000068
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Assess quality of life of patients using prolonged oxygen therapy

Conditions

ILD; COPD

Keywords

Quality of life; Monitoring remote; ILD; COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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.

  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

• Change in psychosocial symptoms

  Change from baseline in 30 days over 90 days

• Change in dyspnea

  Change from baseline in 30 days over 90 days

Other Outcomes (3)

• Adherence

  Baseline

• Exarcebations

  Baseline

• Função pulmonar

  Baseline

Study Arms (2)

Group Monitoring

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Group Monitoring BEHAVIORAL

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.

Group Monitoring

Control Group BEHAVIORAL

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

Control Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Air Liquide SA: collaborator

Study Sites (1)

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

São Paulo, São Paulo, 05360-160, Brazil

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Celso RF Carval, Diretor do Estudo

CONTACT

55 11 98415-3234; cscarval@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomizations will be carried out blindly, that is, by an evaluator who will not be directly involved in the intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: March 18, 2025
• Study Start: November 10, 2024
• Primary Completion: July 30, 2025
• Study Completion: December 15, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-01

Locations

BR (1)