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)

NCT02756533 | Terminated

• 1 other identifier: 38RC15.179
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  one year

Secondary Outcomes (5)

• Number of un-programmed hospitalizations or death

  one year

• External validation of the algorithm to early detect COPD exacerbation by all parameters recorded by NIV of both groups of patients

  one year

• Length of hospitalization for worsening of cardio-respiratory symptoms

  one year

• medical cost

  one year

• Quality of life assessed by SRI (Severe respiratory Insufficiency) score

  1 year

Study Arms (2)

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.

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.

Other: Placebo

Interventions

Telemonitoring of daily parameters recorded by NIV OTHER

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.

Telemonitoring

Placebo OTHER

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.

control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Philips Healthcare: collaborator
• AGIR à Dom: collaborator

Study Sites (1)

Grenoble University Hospital

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-Louis Pépin, Pr MD PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: April 29, 2016
• Study Start: August 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: July 6, 2020
• Last Updated: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)