Clinical trial NCT01513980: Life-long Monitoring of COPD in Veneto Region
Official title: RENEWING HEALTH - Large Scale Pilot in Veneto Region: Life-long Monitoring in COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease
Telemonitoring
Lead sponsor: Regione Veneto
Sponsor class: OTHER
Collaborators: name: European Commission
name: Azienda Unità Locale Socio Sanitaria n.9 Treviso
name: Azienda ULSS 12 Veneziana
name: Azienda ULSS di Verona e Provincia
name: Azienda ULSS 16 Padova
name: Azienda Ospedaliera di Padova
name: Azienda Ospedaliera Universitaria Integrata Verona
First posted: 2012-01-20
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Health-Related quality of life
timeFrame: 12 months
Secondary outcomes:
measure: Number of bed days for hospitalised patients
timeFrame: 12 months
measure: Number of specialist visits
timeFrame: 12 months
measure: Number of visits to emergency department
timeFrame: 12 months
measure: All cause mortality
timeFrame: 12 months
measure: Anxiety and depression status
timeFrame: 12 months
measure: Number of re-hospitalizations
timeFrame: 12 months
Other outcomes:
Locations:
city: Mestre
country: Italy
facility: Ospedale dell'Angelo - Pulmonology Department
state: Venezia
city: Marzana
country: Italy
facility: Ospedale di Marzana - Rehabilitative respiratory unit
state: Verona
city: Padova
country: Italy
facility: Local Health Autority n.16 Padova - Pulmonology outpatient clinic
city: Padova
country: Italy
facility: Hospital Trust of Padova - Respiratory Physiopathology Department
city: Treviso
country: Italy
facility: Ospedale Ca'Foncello - Pulmonology Department
city: Verona
country: Italy
facility: Hospital Trust of Verona - Pneumonology Department
Study officials:
affiliation: Local Health authority Veneziana
name: Massimo Fusello, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vianello A, Fusello M, Gubian L, Rinaldo C, Dario C, Concas A, Saccavini C, Battistella L, Pellizzon G, Zanardi G, Mancin S. Home telemonitoring for patients with acute exacerbation of chronic obstructive pulmonary disease: a randomized controlled trial. BMC Pulm Med. 2016 Nov 22;16(1):157. doi: 10.1186/s12890-016-0321-2.