Telemedicine and Ventilator Titration in Chronic Respiratory Patients Initiating Non-invasive Ventilation (TeleMotiNIV)
|ClinicalTrials.gov Identifier: NCT01560741|
Recruitment Status : Unknown
Verified October 2012 by Miguel R. Goncalves, Hospital Sao Joao.
Recruitment status was: Recruiting
First Posted : March 22, 2012
Last Update Posted : October 4, 2012
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease Neuromuscular Disease Chest Wall Disorders Obesity Hypoventilation Syndrome||Device: Telemonitoring tools Device: Usual Care||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Randomized Trial Comparing Telemedicine Monitoring and Titration in Patients Initiating Non-invasive Ventilation With Usual Care (TELEMOTINIV Study)|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||March 2013|
|Estimated Study Completion Date :||May 2013|
Active Comparator: Telemedicine Group
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.
Device: Telemonitoring tools
Patients will go home with telemedicine tools to monitor efficacy and compliance of non-invasive home mechanical ventilation
Other Name: wireless transmiter
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.
Device: Usual Care
The assessment of efficacy and compliance will be monitor at the end of third month. This is the date of the scheduled hospital visit.
Other Name: Hospital visit
- 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.
- Health Economics Evaluation [ Time Frame: 9 months ]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
- Health related Quality of Life [ Time Frame: 9 months ]Incremental gains in quality of life will be evalueted from a clinical perspective and as an investment.
- Arterial Blood Gases [ Time Frame: 9 months ]We aim to detect a
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01560741
|Contact: João Carlos Winck, PhD||+351 225 512 100 ext email@example.com|
|Contact: Miguel Gonçalves, PhD||+351 225 512 100 ext firstname.lastname@example.org|
|Hospital de S.João||Recruiting|
|Porto, Portugal, 4200-319|
|Principal Investigator: João Carlos Winck, PhD|
|Principal Investigator:||J C Winck, Phd||Hospital de S. João|