Life-long Monitoring of COPD in Veneto Region

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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RENEWING HEALTH - Large Scale Pilot in Veneto Region: Life-long Monitoring in COPD

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Procedure: self-monitoring for patients with severe COPD
* Procedure: nurse-monitoring for patients with severe COPD


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Treatment as usual | |
| Experimental: Self monitoring for patients with COPD<br>Procedure: self-monitoring for patients with severe COPD | Procedure: self-monitoring for patients with severe COPD<br>* 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<br>|
| Experimental: Nurse monitoring for patients with COPD<br>Procedure: nurse-monitoring for patients with severe COPD | Procedure: nurse-monitoring for patients with severe COPD<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-Related quality of life | Health-Related Quality of Life is assessed by the SF-36 questionnaire | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of bed days for hospitalised patients |  | 12 months | 
| Number of specialist visits |  | 12 months | 
| Number of visits to emergency department |  | 12 months | 
| All cause mortality |  | 12 months | 
| Anxiety and depression status | Anxiety and depression status is assessed by Hospital Anxiety and Depression Scale, (HADS). | 12 months | 
| Number of re-hospitalizations |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease, Telemonitoring