Chronic Obstructive Pulmonary DiseasePhase 1TeleMotiNIVNCT01560741
Telemedicine and Ventilator Titration in Chronic Respiratory Patients Initiating Non-invasive Ventilation
A Phase 1 study testing Telemonitoring tools in people with Chronic Obstructive Pulmonary Disease and Neuromuscular Disease, run by Hospital Sao Joao at 1 site in Portugal.
Trial summary
The critical nature of respiratory diseases, the continuously increasing prevalence of these conditions, and the subjective perception of patients vis-à-vis their pulmonary function and health status underscore the importance of home telemonitoring. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Neuromuscular Disease, Chest Wall Disorders
- What is being tested?
- Telemonitoring tools
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 sitePortugal
- Study dates
- Jul 2012to May 2013
- Phase
- Phase 1
- 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- OHS:
- PaCO2 > 45 mmHg;
- IMC > 40 Kg/m2
- COPD:
- Age < 80 years;
- Receiving appropriate medical therapy according to gold guidelines
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- Long-term oxygen therapy (LTOT) for at least 3 months;
- PaCO2 > 50 mmHg during room air
- ph > 7,35 and free from exacerbations in the 4 weeks preceding recruitment;
- One exacerbation in the last year before preceding recruitment with necessity of NIV in the acute care setting;
- FEV1 < 1,5l or < 50% predicted;
- FEV1/FVC < 60%
- Total Lung Capacity (TLC)≥ 90% predicted;
- PaO2 < 60 mmHg breathing room air at rest.
- NMD and CWD:
- PaCO2 > 45 mmHg;
- Significant nocturnal desaturation
- FVC < 50% predicted;
- SNIP < 40 cmH20
- MIP < 60% predicted
- Ortopnea;
- 20% drop of VC in supine position.
Who cannot join
- OHS:
- COPD
- NMD
- COPD:
- 15% increase in FEV1 after inhaled Salbutamol (200 µg);
- Active smoking;
Show all 13Show fewer
- History of OSA (with AHI > 15 episodes.h-1)
- NMD and CWD:
- COPD;
- OHS;
- PCF < 270;
- Severe bulbar weakness (ALSFRS bulbar subscore 0-3)
- MIC/VC=1
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Hospital de S.João
Porto, Porto District, 4200-319
João Carlos Winck, PhD
About this study
Official title: Randomized Trial Comparing Telemedicine Monitoring and Titration in Patients Initiating Non-invasive Ventilation With Usual Care (TELEMOTINIV Study)
The critical nature of respiratory diseases, the continuously increasing prevalence of these conditions, and the subjective perception of patients vis-à-vis their pulmonary function and health status underscore the importance of home telemonitoring. These conditions are critical and necessitate close and regular monitoring that may be achieved at distance using telemonitoring. This study will assess a number of measures both at baseline and post-intervention from a number of domains, including Arterial Blood Gases (ABG), BiPAP-related data, chronic respiratory failure symptoms, health-related quality of life, patients satisfaction and utilization of healthcare resources.
Read the detailed description
In recent years home care is becoming increasingly used and considered by some the future of healthcare. Home mechanical ventilation has been shown to improve morbidity and mortality in patients with chronic respiratory failure of different aetiologies. A French survey suggests an increase of 12% of cases per year. With the prospect of a substantial increase of ventilated patients at home, facilities and resources have not been proportionally growing, so new approaches should be investigated and addressed to absorb this constant flux of patients.
Telemedicine is defined as the broad use of electronic and communications technologies to provide and support remote monitoring of health status. It has been shown to be an effective alternative model of care for managing chronic diseases. It as also been shown to reduce healthcare costs and is a major topic on the agendas of health and social care policies in Europe.
Home telemonitoring of respiratory conditions results in early identification of deteriorations in patient condition and symptom control.
However, evidence on the magnitude of clinical and structural effects remains preliminary, with variations in study approaches and an absence of robust study designs and formal evaluations.
The objective is gathering data that can be help to establish guidelines for non invasive home mechanical ventilation initiation and quality control.
- Conditions
- Chronic Obstructive Pulmonary Disease, Neuromuscular Disease, Chest Wall Disorders, Obesity Hypoventilation Syndrome
- Being tested
- Telemonitoring tools, Usual Care
- Keywords
- Chronic respiratory failure, Noninvasive Mechanical Ventilation, Home-care, Telemedicine, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Neuromuscular Diseases, Obesity Hypoventilation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemonitoring toolsDevice
Also called wireless transmiter
Patients will go home with telemedicine tools to monitor efficacy and compliance of non-invasive home mechanical ventilation
Usual CareDevice
Also called Hospital visit
The assessment of efficacy and compliance will be monitor at the end of third month. This is the date of the scheduled hospital visit.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine Group | Active comparator | Patients will be initiated and adapted on non-invasive home mechanical ventilation in Pulmonology Department of S. João Hospital, in an outpatient setting, according to the prevailing standard of care for Chronic Respiratory Diseases patients in this unit. Patients will be provided with a ventilator outfitted with a wireless transmitter to allow the remote data collection of compliance and efficacy information. While patient sleeps, data is collected. If abnormalities criteria will be detected, remote titration of ventilator settings will be done to optimise therapy. Patient will be monitored again and data analyzed. This procedure will be repeated until we obtained the optimal ventilator parameters for each patient in this group. Nocturnal oximetry under home mechanical non-invasive ventilation will be carried out after one week and one month of treatment. Subjects also receive pre-arranged telephone calls to assist with progress. Receives: Device: Telemonitoring tools |
| Usual care | Other | Patients will be initiated and adapted on non-invasive home mechanical ventilation in Pulmonology Department of S. João Hospital, in an outpatient setting, according to the prevailing standard of care for Chronic Respiratory Diseases patients in this unit. Patients will be assessed by a hospital visit scheduled at the end of third month after their initial adaptation. In this hospital visit data provided by the ventilator will be transferred to research team computer so they could evaluate patient compliance and efficacy of ventilation criteria under the parameters used at home present at the time of assessment. If abnormality criteria will be detected, re-titration of ventilator settings will be made. Patients will be encouraged to call their respiratory consultant any time they had a problem or concern. Receives: Device: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nocturnal noninvasive ventilation compliance per day
We aim to detect a difference of 1 hour in the mean of nightly hours of use, assuming a standard deviation (SD) of 2 hours.
Measured: 9 months
Secondary outcomes (3)
Health Economics Evaluation
This project project will randomize 2 distinct groups adopting different tecnhologies so we will be able to quantify the economic/budget impacts for each alternative
Measured: 9 months
Health related Quality of Life
Incremental gains in quality of life will be evalueted from a clinical perspective and as an investment.
Measured: 9 months
Arterial Blood Gases
We aim to detect a
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startJul 2012
- Primary completionMar 2013 (estimated)
- Study completionMay 2013 (estimated)
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Sao Joao
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel R. Goncalves, Hospital Sao Joao
- Investigators
- J C Winck, Phd, Principal investigator, Hospital de S. João
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01560741
- Sponsor's protocol ID
- TeleMotiNIV2012
- Acronym
- TeleMotiNIV
- Status last verified
- Oct 2012
- First submitted
- 20 Mar 2012
- Last updated
- 4 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Telemedicine Monitoring and Titration in Patients Initiating Non-invasive Ventilation With Usual Care (TELEMOTINIV Study)
- ClinicalTrials.gov ID
- NCT01560741
- Acronym / sponsor ID
- TeleMotiNIV / TeleMotiNIV2012
- Conditions
- Chronic Obstructive Pulmonary Disease, Neuromuscular Disease, Chest Wall Disorders, Obesity Hypoventilation Syndrome
- Keywords
- Chronic respiratory failure, Noninvasive Mechanical Ventilation, Home-care, Telemedicine, COPD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Hospital Sao JoaoUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 22 Mar 2012 (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.
The critical nature of respiratory diseases, the continuously increasing prevalence of these conditions, and the subjective perception of patients vis-à-vis their pulmonary function and health status underscore the importance of home telemonitoring. These conditions are critical and necessitate close and regular monitoring that may be achieved at distance using telemonitoring. This study will assess a number of measures both at baseline and post-intervention from a number of domains, including Arterial Blood Gases (ABG), BiPAP-related data, chronic respiratory failure symptoms, health-related quality of life, patients satisfaction and utilization of healthcare resources.
Detailed description
In recent years home care is becoming increasingly used and considered by some the future of healthcare. Home mechanical ventilation has been shown to improve morbidity and mortality in patients with chronic respiratory failure of different aetiologies. A French survey suggests an increase of 12% of cases per year. With the prospect of a substantial increase of ventilated patients at home, facilities and resources have not been proportionally growing, so new approaches should be investigated and addressed to absorb this constant flux of patients.
Telemedicine is defined as the broad use of electronic and communications technologies to provide and support remote monitoring of health status. It has been shown to be an effective alternative model of care for managing chronic diseases. It as also been shown to reduce healthcare costs and is a major topic on the agendas of health and social care policies in Europe.
Home telemonitoring of respiratory conditions results in early identification of deteriorations in patient condition and symptom control.
However, evidence on the magnitude of clinical and structural effects remains preliminary, with variations in study approaches and an absence of robust study designs and formal evaluations.
The objective is gathering data that can be help to establish guidelines for non invasive home mechanical ventilation initiation and quality control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine Group | Active comparator | Device: Telemonitoring toolsPatients will be initiated and adapted on non-invasive home mechanical ventilation in Pulmonology Department of S. João Hospital, in an outpatient setting, according to the prevailing standard of care for Chronic Respiratory Diseases patients in this unit. Patients will be provided with a ventilator outfitted with a wireless transmitter to allow the remote data collection of compliance and efficacy information. While patient sleeps, data is collected. If abnormalities criteria will be detected, remote titration of ventilator settings will be done to optimise therapy. Patient will be monitored again and data analyzed. This procedure will be repeated until we obtained the optimal ventilator parameters for each patient in this group. Nocturnal oximetry under home mechanical non-invasive ventilation will be carried out after one week and one month of treatment. Subjects also receive pre-arranged telephone calls to assist with progress. |
| Usual care | Other | Device: Usual CarePatients will be initiated and adapted on non-invasive home mechanical ventilation in Pulmonology Department of S. João Hospital, in an outpatient setting, according to the prevailing standard of care for Chronic Respiratory Diseases patients in this unit. Patients will be assessed by a hospital visit scheduled at the end of third month after their initial adaptation. In this hospital visit data provided by the ventilator will be transferred to research team computer so they could evaluate patient compliance and efficacy of ventilation criteria under the parameters used at home present at the time of assessment. If abnormality criteria will be detected, re-titration of ventilator settings will be made. Patients will be encouraged to call their respiratory consultant any time they had a problem or concern. |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (22 listed)
- PaCO2 > 45 mmHg;
- IMC > 40 Kg/m2
- Age < 80 years;
- Receiving appropriate medical therapy according to gold guidelines
- Long-term oxygen therapy (LTOT) for at least 3 months;
Key exclusion criteria (13 listed)
- COPD
- NMD
- 15% increase in FEV1 after inhaled Salbutamol (200 µg);
- Active smoking;
- History of OSA (with AHI > 15 episodes.h-1)
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 toolsAlso: wireless transmiterPatients will go home with telemedicine tools to monitor efficacy and compliance of non-invasive home mechanical ventilation | Device | Telemedicine Group |
| Usual CareAlso: Hospital visitThe assessment of efficacy and compliance will be monitor at the end of third month. This is the date of the scheduled hospital visit. | Device | Usual care |
Primary outcome
Nocturnal noninvasive ventilation compliance per day
Time frame: 9 months
We aim to detect a difference of 1 hour in the mean of nightly hours of use, assuming a standard deviation (SD) of 2 hours.
3 secondary outcomes
Health Economics Evaluation
Time frame: 9 months
Health related Quality of Life
Time frame: 9 months
Arterial Blood Gases
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2012.
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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.
J C Winck, Phd principal investigator
Hospital de S. João
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Telemonitoring tools in people with Chronic Obstructive Pulmonary Disease and Neuromuscular Disease, run by Hospital Sao Joao at 1 site in Portugal.
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 22 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 4 Oct 2012. 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 Portugal. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact João Carlos Winck, PhD (+351 225 512 100 ext. 1567, jcwfc@hsjoao.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nocturnal noninvasive ventilation compliance per day (time frame: 9 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 4 Oct 2012.