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NCT Number: NCT06882265

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

Assess quality of life of patients using prolonged oxygen therapy

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

São Paulo, 05360-160, Brazil

Location status: Recruiting

Location contact

Celso RF Carvalho, PhD

CONTACT

[email protected]

55 11 98415-3234

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Health-related quality of life (HRQOL): assessed using the EQ-5D-5L Questionnaire

    Time frame: 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 outcomes

  1. 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.

    Time frame: 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

  2. Changes related to quality of life factors in interstitial lung disease - King's Brief Interstitial Lung Disease (K-BILD)

    Time frame: 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.

  3. Change in psychosocial symptoms

    Time frame: 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.

  4. Change in dyspnea

    Time frame: 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.

Other outcomes

  1. Adherence

    Time frame: Baseline

    Evaluated according to the data included in the application and responses to questionnaires.

  2. Exarcebations

    Time frame: Baseline

    Assessed through changes or alterations in vital signs of heart rate and/or oxygen saturation through the wearable

  3. Função pulmonar

    Time frame: Baseline

    Lung volumes will be assessed by spirometry

Study contacts

Contact information is provided by the study sponsor or research team.

Celso RF Carval, Diretor do Estudo

CONTACT

[email protected]

55 11 98415-3234

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Air Liquide SA

Registry information

Official study title

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

Acronym: ILD; COPD

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2025
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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