Chronic Obstructive Pulmonary DiseaseEXA-VNI2NCT02756533
Impact of a Telemonitoring Program on the Rate of Hospitalizations for Worsening of Cardio-respiratory Symptoms in COPD Patients Treated at Home by Long-term Non-invasive Ventilation (NIV)
A study testing Telemonitoring of daily parameters recorded by NIV in people with Chronic Obstructive Pulmonary Disease, run by University Hospital, Grenoble at 1 site in France.
Trial summary
COPD is characterized by non-reversible chronic airway obstruction. Its evolution is punctuated by successive exacerbations precipitating the progression of the disease and its co-morbidities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Telemonitoring of daily parameters recorded by NIV
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2016to 6 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- COPD
- Treated by long term NIV
- Compliance over 0h
- Hospitalized for worsening of cardio-respiratory symptoms at least once during the past year
- With social security coverage
- Non inclusion Criteria:
Show all 11Show fewer
- Evolutionary pathology (excluding COPD) may be life-threatening in the short term (1 year) (cancer, neuromuscular disease rapidly changing) (doctor's discretion)
- Patients whom referring general practitioner or pulmonologist is refusing to participate
- Person deprived of liberty
- Major protected by law
- Pregnant woman
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Telemonitoring Program on the Rate of Hospitalizations for Worsening of Cardio-respiratory Symptoms in COPD Patients Treated at Home by Long-term Non-invasive Ventilation (NIV): a Randomized Controlled Trial
COPD is characterized by non-reversible chronic airway obstruction. Its evolution is punctuated by successive exacerbations precipitating the progression of the disease and its co-morbidities. The most severe exacerbations are the source of frequent hospitalizations that strongly affect the patient's quality of life and are associated with increased mortality. The diagnosis of exacerbation is mainly clinical but patients frequently consult their doctor too late which may lead to delays in care. However, the early detection and management of these exacerbations can reduce their impact and in particular avoid hospitalization or shorten their duration.
In France, long term Non-Invasive Ventilation (NIV) is a widely used treatment modality in COPD patients with chronic alveolar hypoventilation who have frequent exacerbations. The investigators have demonstrated in a previous study that the analysis of parameters from software embedded in the NIV device can reliably predict the occurrence of an exacerbation. The investigators hypothesize that the daily transmission via a telemonitoring platform of the ventilation parameters of patients, together with an ad hoc warning system, would reduce the rate of hospitalization for COPD patients treated at home with NIV thanks to the early detection and early treatment of these exacerbations.
The purpose of the study is to compare if a program of telemonitoring using the parameters stored by the NIV impact the rate of hospitalization for worsening of cardiorespiratory symptoms in COPD patients versus standard care over a one year period.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is characterized by non-reversible chronic airway obstruction associated with co-morbidities and is the third leading cause of death worldwide. Its evolution is punctuated by successive exacerbations precipitating the progression of the disease and its co-morbidities. The most severe exacerbations are the source of frequent hospitalizations that strongly affect the patient's quality of life and are associated with increased mortality. The diagnosis of exacerbation is mainly clinical but patients frequently consult their doctor too late which may lead to delays in care. However, the early detection and management of these exacerbations can reduce their impact and in particular avoid hospitalization or shorten their duration.
In France, long term Non-Invasive Ventilation (NIV) is a widely used treatment modality in COPD patients with chronic alveolar hypoventilation who have frequent exacerbations. In France, 7000-10000 COPD patients are currently treated with NIV. Recent NIV respirators are fitted with embedded software that provides details on treatment adherence (daily use, number of sessions/day, number of days of use over a given period etc) and on a number of ventilatory parameters measured during treatment (minute ventilation, tidal volume, respiratory rate, leaks, cycles triggered by the patient, etc.).
In a preliminary study, including more than 60 COPD patients treated with NIV, the investigators demonstrated that the analysis of parameters from software embedded in the NIV device can reliably predict the occurrence of an exacerbation in following five days.
The investigators hypothesize that the daily transmission via a telemonitoring platform of the ventilation parameters of patients, together with an ad hoc warning system, would reduce the rate of hospitalization for COPD patients treated at home with NIV thanks to the early detection and early treatment of these exacerbations.
The physiological and symptomatic changes that accompany an exacerbation can be detected by daily questionnaires, monitoring devices worn by the patient or easy to use appliances (respiratory rate sensor, touch pad for daily symptoms). These expensive devices require active patient involvement and a certain degree of skill by the patients, which limits their use. The main innovation of this project is that patients already have NIV treatment reimbursed by their health insurance and no further action will be required on the part of the patient to detect worsening. Changes recorded by the ventilator settings will trigger an alert and if needed early and appropriate patient care can be initiated.
Main objective:
The purpose of the study is to compare if a program of telemonitoring using the parameters stored by the NIV impact the rate of hospitalization for worsening of cardiorespiratory symptoms in COPD patients versus standard care over a one year period.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Telemonitoring of daily parameters recorded by NIV, Placebo
- 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.
Telemonitoring of daily parameters recorded by NIVOther
Daily telemonitoring of breathing rate, % of trigger cycles, daily usage of the NIV will go through an algorithm generating alerts when variations will go beyond normal. When an alert is received, a nurse will evaluate the symptoms of the patient by a standardized phone call questionnaire. The results will be transmitted to a referent practitioner who will decide what the patient should do.
Recommendations will be transferred to the patient within 36 hours.
PlaceboOther
Daily telemonitoring of breathing rate, % of trigger cycles, daily usage of the NIV will go through an algorithm generating alerts when variations will go beyond normal. Alerts will only be collected, the patient will not be contacted by phone during the alert.
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring | Experimental | Telemonitoring of daily parameters recorded by NIV, transmitted to a remote monitoring platform. When an alert is received the patient is contacted by phone by a nurse to evaluate the worsening of symptoms. Information are transferred to a referent physician for further medical care if needed. Receives: Other: Telemonitoring of daily parameters recorded by NIV |
| control | Placebo comparator | Telemonitoring of daily parameters by NIV, transmitted to a remote monitoring platform with no generation of alerts.
Phone calls to patient during the follow-up like "false alerts" for the blind procedure. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hospitalizations for worsening for cardio-respiratory symptoms.
An hospitalization being an entry in any hospital or clinic, whatever the length of the stay. The validation of cardiorespiratory worsening being the reason of the hospitalization will be done by a single independent retrospective committee of two doctors. The doctors won't be investigators of the study.Comparison between the two arms will be done.
Measured: one year
Secondary outcomes (5)
Number of un-programmed hospitalizations or death
Comparison between the two arms
Measured: one year
External validation of the algorithm to early detect COPD exacerbation by all parameters recorded by NIV of both groups of patients
all parameters recorded by NIV done will be analyzed according to COPD exacerbations date validated by a single independent retrospective committee of two doctors. The predictive value and sensitivity and the specificity of individual parameters with different algorithm on the previous days of COPD exacerbation will be analyzed. Composite scores of several parameters will be analyzed.
Measured: one year
Length of hospitalization for worsening of cardio-respiratory symptoms
Comparison between the two arms
Measured: one year
medical cost
Comparison between the two arms
Measured: one year
Quality of life assessed by SRI (Severe respiratory Insufficiency) score
Comparison between the two arms of the scores of the SRI questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startAug 2016
- Primary completionFeb 2017
- Study completion6 Jul 2020
Why it stopped: pilot feasibility study completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare, AGIR à Dom
- Responsible party
- Sponsor
- Investigators
- Jean-Louis Pépin, Pr MD PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756533
- Sponsor's protocol ID
- 38RC15.179
- Acronym
- EXA-VNI2
- Status last verified
- Apr 2023
- First submitted
- 22 Mar 2016
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Telemonitoring Program on the Rate of Hospitalizations for Worsening of Cardio-respiratory Symptoms in COPD Patients Treated at Home by Long-term Non-invasive Ventilation (NIV): a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02756533
- Acronym / sponsor ID
- EXA-VNI2 / 38RC15.179
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: pilot feasibility study completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Philips Healthcare, AGIR à Dom
- Study start
- Aug 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- 6 Jul 2020 (actual)
- First posted
- 29 Apr 2016 (estimated)
- 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.
COPD is characterized by non-reversible chronic airway obstruction. Its evolution is punctuated by successive exacerbations precipitating the progression of the disease and its co-morbidities. The most severe exacerbations are the source of frequent hospitalizations that strongly affect the patient's quality of life and are associated with increased mortality. The diagnosis of exacerbation is mainly clinical but patients frequently consult their doctor too late which may lead to delays in care. However, the early detection and management of these exacerbations can reduce their impact and in particular avoid hospitalization or shorten their duration.
In France, long term Non-Invasive Ventilation (NIV) is a widely used treatment modality in COPD patients with chronic alveolar hypoventilation who have frequent exacerbations. The investigators have demonstrated in a previous study that the analysis of parameters from software embedded in the NIV device can reliably predict the occurrence of an exacerbation. The investigators hypothesize that the daily transmission via a telemonitoring platform of the ventilation parameters of patients, together with an ad hoc warning system, would reduce the rate of hospitalization for COPD patients treated at home with NIV thanks to the early detection and early treatment of these exacerbations.
The purpose of the study is to compare if a program of telemonitoring using the parameters stored by the NIV impact the rate of hospitalization for worsening of cardiorespiratory symptoms in COPD patients versus standard care over a one year period.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is characterized by non-reversible chronic airway obstruction associated with co-morbidities and is the third leading cause of death worldwide. Its evolution is punctuated by successive exacerbations precipitating the progression of the disease and its co-morbidities. The most severe exacerbations are the source of frequent hospitalizations that strongly affect the patient's quality of life and are associated with increased mortality. The diagnosis of exacerbation is mainly clinical but patients frequently consult their doctor too late which may lead to delays in care. However, the early detection and management of these exacerbations can reduce their impact and in particular avoid hospitalization or shorten their duration.
In France, long term Non-Invasive Ventilation (NIV) is a widely used treatment modality in COPD patients with chronic alveolar hypoventilation who have frequent exacerbations. In France, 7000-10000 COPD patients are currently treated with NIV. Recent NIV respirators are fitted with embedded software that provides details on treatment adherence (daily use, number of sessions/day, number of days of use over a given period etc) and on a number of ventilatory parameters measured during treatment (minute ventilation, tidal volume, respiratory rate, leaks, cycles triggered by the patient, etc.).
In a preliminary study, including more than 60 COPD patients treated with NIV, the investigators demonstrated that the analysis of parameters from software embedded in the NIV device can reliably predict the occurrence of an exacerbation in following five days.
The investigators hypothesize that the daily transmission via a telemonitoring platform of the ventilation parameters of patients, together with an ad hoc warning system, would reduce the rate of hospitalization for COPD patients treated at home with NIV thanks to the early detection and early treatment of these exacerbations.
The physiological and symptomatic changes that accompany an exacerbation can be detected by daily questionnaires, monitoring devices worn by the patient or easy to use appliances (respiratory rate sensor, touch pad for daily symptoms). These expensive devices require active patient involvement and a certain degree of skill by the patients, which limits their use. The main innovation of this project is that patients already have NIV treatment reimbursed by their health insurance and no further action will be required on the part of the patient to detect worsening. Changes recorded by the ventilator settings will trigger an alert and if needed early and appropriate patient care can be initiated.
Main objective:
The purpose of the study is to compare if a program of telemonitoring using the parameters stored by the NIV impact the rate of hospitalization for worsening of cardiorespiratory symptoms in COPD patients versus standard care over a one year period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring | Experimental | Other: Telemonitoring of daily parameters recorded by NIVTelemonitoring of daily parameters recorded by NIV, transmitted to a remote monitoring platform. When an alert is received the patient is contacted by phone by a nurse to evaluate the worsening of symptoms. Information are transferred to a referent physician for further medical care if needed. |
| control | Placebo comparator | Other: PlaceboTelemonitoring of daily parameters by NIV, transmitted to a remote monitoring platform with no generation of alerts. Phone calls to patient during the follow-up like "false alerts" for the blind procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- COPD
- Treated by long term NIV
- Compliance over 0h
- Hospitalized for worsening of cardio-respiratory symptoms at least once during the past year
- With social security coverage
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Telemonitoring of daily parameters recorded by NIVDaily telemonitoring of breathing rate, % of trigger cycles, daily usage of the NIV will go through an algorithm generating alerts when variations will go beyond normal. When an alert is received, a nurse will evaluate the symptoms of the patient by a standardized phone call questionnaire. The results will be transmitted to a referent practitioner who will decide what the patient should do. Recommendations will be transferred to the patient within 36 hours. | Other | Telemonitoring |
| PlaceboDaily telemonitoring of breathing rate, % of trigger cycles, daily usage of the NIV will go through an algorithm generating alerts when variations will go beyond normal. Alerts will only be collected, the patient will not be contacted by phone during the alert. | Other | control |
Primary outcome
Number of hospitalizations for worsening for cardio-respiratory symptoms.
Time frame: one year
An hospitalization being an entry in any hospital or clinic, whatever the length of the stay. The validation of cardiorespiratory worsening being the reason of the hospitalization will be done by a single independent retrospective committee of two doctors. The doctors won't be investigators of the study.Comparison between the two arms will be done.
5 secondary outcomes
Number of un-programmed hospitalizations or death
Time frame: one year
External validation of the algorithm to early detect COPD exacerbation by all parameters recorded by NIV of both groups of patients
Time frame: one year
Length of hospitalization for worsening of cardio-respiratory symptoms
Time frame: one year
medical cost
Time frame: one year
Quality of life assessed by SRI (Severe respiratory Insufficiency) score
Time frame: 1 year
Results and safety
The study was stopped early (reason given: pilot feasibility study completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jean-Louis Pépin, Pr MD PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring of daily parameters recorded by NIV in people with Chronic Obstructive Pulmonary Disease, run by University Hospital, Grenoble at 1 site in France.
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 11 inclusion and 0 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: stopped early, as of the sponsor's last update on 24 Apr 2023. 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 France. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: pilot feasibility study completed). Results are not available in the source record.
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?
Number of hospitalizations for worsening for cardio-respiratory symptoms. (time frame: one year). 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 24 Apr 2023.