Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Chronic Obstructive Pulmonary Disease, Telemonitoring
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.
Interventions
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
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.
Sponsors
European Commission
Azienda Unità Locale Socio Sanitaria n.9 Treviso
Azienda ULSS 12 Veneziana
Azienda ULSS di Verona e Provincia
Azienda ULSS 16 Padova
Azienda Ospedaliera di Padova
Azienda Ospedaliera Universitaria Integrata Verona
Regione Veneto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health-Related quality of life | 12 months | Health-Related Quality of Life is assessed by the SF-36 questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of specialist visits | 12 months | — |
| Number of visits to emergency department | 12 months | — |
| Number of bed days for hospitalised patients | 12 months | — |
| Anxiety and depression status | 12 months | Anxiety and depression status is assessed by Hospital Anxiety and Depression Scale, (HADS). |
| Number of re-hospitalizations | 12 months | — |
| All cause mortality | 12 months | — |
Countries
Italy
Outcome results
None listed