NCT01513980

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 20, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

April 17, 2017

Status Verified

January 1, 2012

Enrollment Period

2.5 years

First QC Date

January 17, 2012

Last Update Submit

April 13, 2017

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic Obstructive Pulmonary DiseaseTelemonitoring

Outcome Measures

Primary Outcomes (1)

  • Health-Related quality of life

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

    12 months

Secondary Outcomes (6)

  • 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

    12 months

  • +1 more secondary outcomes

Study Arms (3)

Control group

NO INTERVENTION

Treatment as usual

Self monitoring for patients with COPD

EXPERIMENTAL

Procedure: self-monitoring for patients with severe COPD

Procedure: self-monitoring for patients with severe COPD

Nurse monitoring for patients with COPD

EXPERIMENTAL

Procedure: nurse-monitoring for patients with severe COPD

Procedure: nurse-monitoring for patients with severe COPD

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

Self monitoring for patients with COPD
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.

Nurse monitoring for patients with COPD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years.
  • COPD GOLD class 3-4
  • Life expectance \> 12 months

You may not qualify if:

  • Patient unable to use the equipment provided (alone or assisted).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Local Health Autority n.16 Padova - Pulmonology outpatient clinic

Padua, Padova, 35127, Italy

Location

Hospital Trust of Padova - Respiratory Physiopathology Department

Padua, Padova, 35128, Italy

Location

Ospedale Ca'Foncello - Pulmonology Department

Treviso, Treviso, 31100, Italy

Location

Ospedale dell'Angelo - Pulmonology Department

Mestre, Venezia, 30174, Italy

Location

Ospedale di Marzana - Rehabilitative respiratory unit

Marzana, Verona, 37034, Italy

Location

Hospital Trust of Verona - Pneumonology Department

Verona, Verona, 37124, Italy

Location

Related Publications (1)

  • 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.

    PMID: 27876029DERIVED

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Massimo Fusello, MD

    Local Health authority Veneziana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2012

First Posted

January 20, 2012

Study Start

November 1, 2011

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

April 17, 2017

Record last verified: 2012-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(6)