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Completed

NCT Number: NCT01513980

Life-long Monitoring of COPD in Veneto Region

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Trust of Padova - Respiratory Physiopathology Department, Padova, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

self-monitoring for patients with severe COPD

Procedure

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 COPD

Procedure

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.

Primary outcomes

  1. Health-Related quality of life

    Time frame: 12 months

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

Secondary outcomes

  1. Number of bed days for hospitalised patients

    Time frame: 12 months

  2. Number of specialist visits

    Time frame: 12 months

  3. Number of visits to emergency department

    Time frame: 12 months

  4. All cause mortality

    Time frame: 12 months

  5. Anxiety and depression status

    Time frame: 12 months

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

  6. Number of re-hospitalizations

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Regione Veneto

Other

Collaborators

  • Azienda Ospedaliera Universitaria Integrata Verona
  • Azienda Ospedaliera di Padova
  • Azienda ULSS 12 Veneziana
  • Azienda ULSS 16 Padova
  • Azienda ULSS di Verona e Provincia
  • Azienda Unità Locale Socio Sanitaria n.9 Treviso
  • European Commission

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 20, 2012
Registry last updated
Apr 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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