BPCOEProTeleNCT07697105
Effectiveness of the Telemonitoring Program for Patients With Chronic Obstructive Pulmonary Disease (COPD)
A study testing Patients included in the intervention group will receive medical telemonitoring using the HCAlert medical device. in people with BPCO, run by Hope Care, S.A.
Trial summary
Telemonitoring systems have already demonstrated their ability to improve clinical follow-up and reduce healthcare resource utilization in patients with chronic respiratory failure treated with non-invasive ventilation (NIV) and/or long-term oxygen therapy (LTOT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BPCO
- What is being tested?
- Patients included in the intervention group will receive medical telemonitoring using the HCAlert medical device.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 30 Nov 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 years or older.
- Patient with a confirmed diagnosis of chronic obstructive pulmonary disease (COPD), classified according to the GOLD ABE classification, who has experienced at least one COPD exacerbation within the previous 12 months.
- Able and willing to provide written informed consent.
- Able to comply with the telemonitoring procedures, including:
- Performing physiological measurements on a regular basis;
- Completing the required questionnaires.
- Covered by a valid health insurance or social security scheme.
Who cannot join
- Receiving long-term oxygen therapy (LTOT) or non-invasive ventilation (NIV), regardless of the duration since prescription.
- Presence of severe, unstable comorbidities that may interfere with the study outcomes, including but not limited to:
- Decompensated heart failure;
- Chronic kidney disease;
- Asthma;
- Other restrictive pulmonary diseases;
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- Psychotic mental disorders.
- Participation in another interventional clinical study within the month preceding enrollment or during the study period.
- Unavailable for follow-up or planning to relocate before completion of study participation.
- Protected populations, including:
- Pregnant or breastfeeding women, or women planning to become pregnant during the study period. For women of childbearing potential not using effective contraception, pregnancy will be ruled out by a urine or blood human chorionic gonadotropin (hCG) test before enrollment.
- Individuals deprived of liberty by judicial or administrative decision, or individuals under legal protection measures.
About this study
Telemonitoring systems have already demonstrated their ability to improve clinical follow-up and reduce healthcare resource utilization in patients with chronic respiratory failure treated with non-invasive ventilation (NIV) and/or long-term oxygen therapy (LTOT). In this severely ill population, telemonitoring enables earlier detection of clinical deteriorations, optimization of therapeutic interventions, and a reduction in unplanned hospitalizations.
Building on these findings, we hypothesize that similar benefits could be achieved in patients with chronic obstructive pulmonary disease (COPD) who are at risk of exacerbations, regardless of their clinical severity (GOLD ABE classification). The implementation of a structured telemonitoring program in this population could therefore help reduce the severity of exacerbations and, ultimately, decrease overall healthcare resource utilization.
Read the detailed description
The primary objective of the intervention is to optimize disease management and reduce the need for hospital-based healthcare resources.
- Personalized Patient Monitoring: The telemonitoring system enables continuous, individualized follow-up, supporting proactive disease management and timely clinical decision-making.
- Early Detection of Exacerbations: The HCAlert system continuously monitors physiological parameters, including heart rate, oxygen saturation (SpO₂), and blood pressure, and uses a triage algorithm to generate clinical alerts. This remote monitoring approach facilitates the early identification of clinical deterioration, allowing timely intervention before the patient's condition worsens, thereby potentially improving clinical outcomes.
- Reduction in Healthcare Resource Utilization: Early clinical intervention is expected to reduce the rate of COPD-related hospitalizations, the number of COPD-related hospital days, and the frequency of COPD exacerbations. These improvements may translate into reduced healthcare resource utilization and lower healthcare costs.
- Improved Quality of Life: By enabling patients to receive continuous monitoring and clinical support while remaining at home, telemonitoring may improve overall quality of life, increase patient reassurance, and promote better adherence to prescribed treatment plans.
- Conditions
- BPCO
- Being tested
- Patients included in the intervention group will receive medical telemonitoring using the HCAlert medical device.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients included in the intervention group will receive medical telemonitoring using the HCAlert medical device.Device
Patients included in the intervention group will receive follow-up through the HCAlert medical telemonitoring device.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients in this group receive medical telemonitoring using the HCAlert platform. Receives: Device: Patients included in the intervention group will receive medical telemonitoring using the HCAlert medical device. |
| Control group | No intervention | Patients in the control group will receive routine medical follow-up every six months, in accordance with standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the long-term impact of the HCAlert telemonitoring program on healthcare resource utilization associated with COPD exacerbations.
The proportion of patients without COPD-related hospitalization or emergency department visits due to a COPD exacerbation over the 12-month follow-up period will be compared between the intervention and control groups. A COPD exacerbation will be defined according to the GOLD recommendations as an acute worsening of respiratory symptoms requiring one or more of the following:
- Initiation of additional treatment, including short-acting bronchodilators, oral corticosteroids, and/or antibiotic therapy;
- An emergency department visit or hospitalization.
Measured: COPD exacerbation over 12 months
Secondary outcomes (10)
To compare the medium-term impact of the HCAlert telemonitoring program on hospitalization related to COPD exacerbations in patients with COPD.
The change in the number of COPD exacerbation-related hospitalizations between baseline and the end of the 12-month follow-up period will be compared between the intervention and control groups.
Measured: 12-month follow-up
To compare the medium-term impact of the HCAlert telemonitoring program on COPD exacerbation-related medical consultations in patients with COPD.
The change in the number of medical consultations related to COPD exacerbations between baseline and the end of the 12-month follow-up period will be compared between the intervention and control groups.
Measured: 12-month follow-up
To evaluate the costs associated with COPD exacerbation-related hospitalizations, emergency department visits, and medical consultations through the HCAlert telemonitoring program.
The difference in costs associated with disease management, based on healthcare resource utilization, between baseline and the end of the 12-month follow-up period will be compared between the intervention and control groups.
Measured: 12 months
To evaluate the impact of the telemonitoring program on the frequency of emergency department visits and medical consultations.
The change between baseline and the end of the 12-month follow-up period will be compared between the intervention and control groups for the following outcomes:
- COPD-related hospitalization rate and COPD-related hospital days rate;
- COPD exacerbation rate.
Measured: 12 months
To describe the sociodemographic characteristics of the study population.
Comparison of the demographic and clinical characteristics of patients receiving telemonitoring and those in the control group.
Measured: 12 months
To evaluate adherence to the telemonitoring program.
Adherence to the telemonitoring program will be assessed based on the number of data entries completed by the patient throughout the follow-up period and for each month of participation (intervention group only).
Measured: 12 months
To evaluate the impact of the HCAlert telemonitoring solution on the quality of life of patients in the intervention group.
The change in quality of life, as measured by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire, between baseline (Month 0), Month 6, and Month 12, will be compared between the intervention and control groups.
Measured: 6 and 12 months
To evaluate the COPD exacerbation rate at 6 months in patients with COPD.
The COPD exacerbation rate over the 6-month follow-up period will be compared between the intervention and control groups.
Measured: 6 months
To evaluate the proportion of patients without COPD exacerbation-related hospitalization or emergency department visits at 6 months.
The proportion of patients without COPD exacerbation-related hospitalization or emergency department visits during the 6-month follow-up period will be compared between the intervention and control groups.
Measured: 6 months
To evaluate the environmental impact of the HCAlert telemonitoring program.
The change in carbon emissions associated with travel for medical consultations between baseline and the end of the 12-month follow-up period will be compared between the intervention and control groups.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPCOStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a national, multicenter, prospective, longitudinal, randomized controlled interventional study with two parallel treatment arms (1:1 allocation), stratified by study center and GOLD ABE classification (Groups A/B vs. Group E).
- Masking
- None (open label)
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hope Care, S.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697105
- Sponsor's protocol ID
- 2026-A00562-49
- Acronym
- EProTele
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Telemonitoring Program for Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT07697105
- Acronym / sponsor ID
- EProTele / 2026-A00562-49
- Conditions
- BPCO
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Hope Care, S.AIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 13 Jul 2026 (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.
Telemonitoring systems have already demonstrated their ability to improve clinical follow-up and reduce healthcare resource utilization in patients with chronic respiratory failure treated with non-invasive ventilation (NIV) and/or long-term oxygen therapy (LTOT). In this severely ill population, telemonitoring enables earlier detection of clinical deteriorations, optimization of therapeutic interventions, and a reduction in unplanned hospitalizations.
Building on these findings, we hypothesize that similar benefits could be achieved in patients with chronic obstructive pulmonary disease (COPD) who are at risk of exacerbations, regardless of their clinical severity (GOLD ABE classification). The implementation of a structured telemonitoring program in this population could therefore help reduce the severity of exacerbations and, ultimately, decrease overall healthcare resource utilization.
Detailed description
The primary objective of the intervention is to optimize disease management and reduce the need for hospital-based healthcare resources.
- Personalized Patient Monitoring: The telemonitoring system enables continuous, individualized follow-up, supporting proactive disease management and timely clinical decision-making.
- Early Detection of Exacerbations: The HCAlert system continuously monitors physiological parameters, including heart rate, oxygen saturation (SpO₂), and blood pressure, and uses a triage algorithm to generate clinical alerts. This remote monitoring approach facilitates the early identification of clinical deterioration, allowing timely intervention before the patient's condition worsens, thereby potentially improving clinical outcomes.
- Reduction in Healthcare Resource Utilization: Early clinical intervention is expected to reduce the rate of COPD-related hospitalizations, the number of COPD-related hospital days, and the frequency of COPD exacerbations. These improvements may translate into reduced healthcare resource utilization and lower healthcare costs.
- Improved Quality of Life: By enabling patients to receive continuous monitoring and clinical support while remaining at home, telemonitoring may improve overall quality of life, increase patient reassurance, and promote better adherence to prescribed treatment plans.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a national, multicenter, prospective, longitudinal, randomized controlled interventional study with two parallel treatment arms (1:1 allocation), stratified by study center and GOLD ABE classification (Groups A/B vs. Group E).
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Patients included in the intervention group will receive medical telemonitoring using the HCAlert medical device.Patients in this group receive medical telemonitoring using the HCAlert platform. |
| Control group | No intervention | –Patients in the control group will receive routine medical follow-up every six months, in accordance with standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female aged 18 years or older.
- Patient with a confirmed diagnosis of chronic obstructive pulmonary disease (COPD), classified according to the GOLD ABE classification, who has experienced at least one COPD exacerbation within the previous 12 months.
- Able and willing to provide written informed consent.
- Able to comply with the telemonitoring procedures, including:
- Performing physiological measurements on a regular basis;
Key exclusion criteria (12 listed)
- Receiving long-term oxygen therapy (LTOT) or non-invasive ventilation (NIV), regardless of the duration since prescription.
- Presence of severe, unstable comorbidities that may interfere with the study outcomes, including but not limited to:
- Decompensated heart failure;
- Chronic kidney disease;
- Asthma;
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 |
|---|---|---|
| Patients included in the intervention group will receive medical telemonitoring using the HCAlert medical device.Patients included in the intervention group will receive follow-up through the HCAlert medical telemonitoring device. | Device | Intervention group |
Primary outcome
To compare the long-term impact of the HCAlert telemonitoring program on healthcare resource utilization associated with COPD exacerbations.
Time frame: COPD exacerbation over 12 months
The proportion of patients without COPD-related hospitalization or emergency department visits due to a COPD exacerbation over the 12-month follow-up period will be compared between the intervention and control groups. A COPD exacerbation will be defined according to the GOLD recommendations as an acute worsening of respiratory symptoms requiring one or more of the following: * Initiation of additional treatment, including short-acting bronchodilators, oral corticosteroids, and/or antibiotic therapy; * An emergency department visit or hospitalization.
10 secondary outcomes
To compare the medium-term impact of the HCAlert telemonitoring program on hospitalization related to COPD exacerbations in patients with COPD.
Time frame: 12-month follow-up
To compare the medium-term impact of the HCAlert telemonitoring program on COPD exacerbation-related medical consultations in patients with COPD.
Time frame: 12-month follow-up
To evaluate the costs associated with COPD exacerbation-related hospitalizations, emergency department visits, and medical consultations through the HCAlert telemonitoring program.
Time frame: 12 months
To evaluate the impact of the telemonitoring program on the frequency of emergency department visits and medical consultations.
Time frame: 12 months
To describe the sociodemographic characteristics of the study population.
Time frame: 12 months
To evaluate adherence to the telemonitoring program.
Time frame: 12 months
To evaluate the impact of the HCAlert telemonitoring solution on the quality of life of patients in the intervention group.
Time frame: 6 and 12 months
To evaluate the COPD exacerbation rate at 6 months in patients with COPD.
Time frame: 6 months
To evaluate the proportion of patients without COPD exacerbation-related hospitalization or emergency department visits at 6 months.
Time frame: 6 months
To evaluate the environmental impact of the HCAlert telemonitoring program.
Time frame: 12 months
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 13 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Patients included in the intervention group will receive medical telemonitoring using the HCAlert medical device. in people with BPCO, run by Hope Care, S.A.
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 7 inclusion and 12 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: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the long-term impact of the HCAlert telemonitoring program on healthcare resource utilization associated with COPD exacerbations. (time frame: COPD exacerbation over 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2026.