ILDILD; COPDNCT06882265
Impact of Remote Vital Signs Monitoring in People Using Long-term Oxygen Therapy
A study testing Group Monitoring in people with ILD and COPD, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Assess quality of life of patients using prolonged oxygen therapy Read more about this study
- Who is it for?
- Ages 18 to 85 years
- What is being tested?
- Group Monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Nov 2024to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP),
São Paulo, São Paulo, 05360-160
Celso RF Carvalho, PhD, 55 11 98415-3234, cscarval@usp.br
About this study
Official title: 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
Read the 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.
- Being tested
- Group Monitoring, Control Group
- Keywords
- Quality of life, Monitoring remote, ILD, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group MonitoringBehavioural
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 GroupBehavioural
In the control group (CG), participants receive only a pulse oximeter and will be monitored monthly by a nurse to administer the questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline in 30 days over 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start10 Nov 2024
- Primary completion30 Jul 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ILDStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Air Liquide SA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882265
- Sponsor's protocol ID
- 68384723900000068
- Acronym
- ILD; COPD
- Status last verified
- Jan 2025
- First submitted
- 18 Feb 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Reis ERMD, Alencar GM, Schneider AM, Fernandes MCT, Dos Santos JMB, Carvalho CRF. Effect of Remote Vital Signs Monitoring in People Receiving Long-Term Oxygen Therapy: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Aug 21;15:e93352. doi: 10.2196/93352.
PubMed 42628026
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Remote Vital Signs Monitoring in People Using Long-term Oxygen Therapy : a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06882265
- Acronym / sponsor ID
- ILD; COPD / 68384723900000068
- Keywords
- Quality of life, Monitoring remote, ILD, COPD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Air Liquide SA
- Study start
- 10 Nov 2024 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 18 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Monitoring | Experimental | Behavioral: Group MonitoringAfter 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). |
| Control Group | Active comparator | Behavioral: Control GroupFor 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group MonitoringIn 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. | Behavioural | Group Monitoring |
| Control GroupIn the control group (CG), participants receive only a pulse oximeter and will be monitored monthly by a nurse to administer the questionnaires. | Behavioural | Control Group |
Primary outcome
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).
4 secondary outcomes
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
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
Change in psychosocial symptoms
Time frame: Change from baseline in 30 days over 90 days
Change in dyspnea
Time frame: Change from baseline in 30 days over 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Derived from this study: PubMed 42628026Reis ERMD, Alencar GM, Schneider AM, Fernandes MCT, Dos Santos JMB, Carvalho CRF. Effect of Remote Vital Signs Monitoring in People Receiving Long-Term Oxygen Therapy: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Aug 21;15:e93352. doi: 10.2196/93352.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Monitoring in people with ILD and COPD, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Celso RF Carval, Diretor do Estudo (55 11 98415-3234, cscarval@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (HRQOL): assessed using the EQ-5D-5L Questionnaire (time frame: Change from baseline in 30 days over 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06882265, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.