Telemedicine and Ventilator Titration in Chronic Respiratory Patients Initiating Non-invasive Ventilation (TeleMotiNIV)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Hospital Sao Joao
Sponsor:
Information provided by (Responsible Party):
Miguel R. Goncalves, Hospital Sao Joao
ClinicalTrials.gov Identifier:
NCT01560741
First received: March 20, 2012
Last updated: October 3, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Neuromuscular Disease
Chest Wall Disorders
Obesity Hypoventilation Syndrome
Device: Telemonitoring tools
Device: Usual Care
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Telemedicine Monitoring and Titration in Patients Initiating Non-invasive Ventilation With Usual Care (TELEMOTINIV Study)

Resource links provided by NLM:


Further study details as provided by Hospital Sao Joao:

Primary Outcome Measures:
  • Nocturnal noninvasive ventilation compliance per day [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Health Economics Evaluation [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Incremental gains in quality of life will be evalueted from a clinical perspective and as an investment.

  • Arterial Blood Gases [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    We aim to detect a


Estimated Enrollment: 128
Study Start Date: July 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Usual care
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

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.

  Eligibility

Ages Eligible for Study:   15 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

OHS:

  • PaCO2 > 45 mmHg;
  • IMC > 40 Kg/m2

COPD:

  • Age < 80 years;
  • Receiving appropriate medical therapy according to gold guidelines
  • 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.

Exclusion Criteria:

OHS:

  • COPD
  • NMD

COPD:

  • 15% increase in FEV1 after inhaled Salbutamol (200 µg);
  • Active smoking;
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01560741

Contacts
Contact: João Carlos Winck, PhD +351 225 512 100 ext 1567 jcwfc@hsjoao.min-saude.pt
Contact: Miguel Gonçalves, PhD +351 225 512 100 ext 1567 goncalvesmr@gmail.com

Locations
Portugal
Hospital de S.João Recruiting
Porto, Portugal, 4200-319
Principal Investigator: João Carlos Winck, PhD         
Sponsors and Collaborators
Hospital Sao Joao
Investigators
Principal Investigator: J C Winck, Phd Hospital de S. João
  More Information

No publications provided

Responsible Party: Miguel R. Goncalves, Clinical Professor, Hospital Sao Joao
ClinicalTrials.gov Identifier: NCT01560741     History of Changes
Other Study ID Numbers: TeleMotiNIV2012
Study First Received: March 20, 2012
Last Updated: October 3, 2012
Health Authority: Portugal: Ethics Committee for Clinical Research

Keywords provided by Hospital Sao Joao:
Chronic respiratory failure
Noninvasive Mechanical Ventilation
Home-care
Telemedicine
COPD

Additional relevant MeSH terms:
Neuromuscular Diseases
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Obesity
Obesity Hypoventilation Syndrome
Hypoventilation
Lung Diseases, Obstructive
Respiratory Tract Diseases
Nervous System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiratory Insufficiency
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on July 24, 2014