Life-long Monitoring of COPD in Veneto Region

Regione Veneto750 enrolled

Overview

The purpose of this study is to evaluate whether the introduction of large-scale telemonitoring of patients with COPD produces benefits in terms of improved health-related quality of life and reduced access to hospital facilities. In addition, the trial evaluates the economic and organisational impact of the new services, and examine their acceptability by patients and health professionals.

The study is designed to evaluate the impact of telemonitoring on the management of COPD compared with outpatient usual care. From a clinical point of view, the trial will allow to investigate how telemonitoring contributes to improve COPD patients health-related quality of life and reduct the access to hospital facilities (re-hospitalizations, bed-days, specialistic and ER visits) and the anxiety about health conditions. A cost-effectiveness and cost-utility analysis will be carried out in order to determine if and how telemonitoring helps to limit the healthcare expenditure. The evaluation will deal also with organizational changes and task shift due to telemonitoring introduction and patients and professionals perception towards the service.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

750

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

self-monitoring for patients with severe COPDPROCEDURE

Patients are equipped with a telemonitoring kit composed by a portable wrist-clinic device for clinical parameters measuring and a gateway device for data transmission. The patient can monitor pulse-oxymetry and heart rate with a frequency set by the clinician in the personalised treatment plan. Data are transmitted to a regional eHealth centre where a group of operators keeps these information under control and alert the reference clinician in case of worsening of symptoms. CAT questionnaire is monthly administrated by phone to the patients

nurse-monitoring for patients with severe COPDPROCEDURE

A nurse is in charge of data collection during home visits with a frequency set by the lung specialist depending to the patient clinical conditions. The nurse uses portable biomedical devices to measure pulse-oxymetry, heart rate, spirometry and if scheduled an arterial blood gas test. Data are transmitted to the clinician who checks them on his laptop in the hospital and completes the visit with the medical report.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years. * COPD GOLD class 3-4 * Life expectance \> 12 months Exclusion Criteria: • Patient unable to use the equipment provided (alone or assisted).

Locations (6)

Local Health Autority n.16 Padova - Pulmonology outpatient clinic

Padova, Padova, Italy

Hospital Trust of Padova - Respiratory Physiopathology Department

Padova, Padova, Italy

Ospedale Ca'Foncello - Pulmonology Department

Treviso, Treviso, Italy

Ospedale dell'Angelo - Pulmonology Department

Mestre, Venezia, Italy

Outcomes

Primary Outcomes

Health-Related quality of life

Health-Related Quality of Life is assessed by the SF-36 questionnaire

Time frame: 12 months

Secondary Outcomes

Number of bed days for hospitalised patients

Time frame: 12 months

Number of specialist visits

Time frame: 12 months

Number of visits to emergency department

Time frame: 12 months

All cause mortality

Time frame: 12 months

Anxiety and depression status

Anxiety and depression status is assessed by Hospital Anxiety and Depression Scale, (HADS).

Time frame: 12 months

Number of re-hospitalizations

Time frame: 12 months

Data from ClinicalTrials.gov

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