RENEWING HEALTH - Large Scale Pilot in Veneto Region: Life-long Monitoring in COPD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- Regione Veneto
- Enrollment
- 750
- Locations
- 6
- Primary Endpoint
- Health-Related quality of life
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
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).
Outcomes
Primary Outcomes
Health-Related quality of life
Time Frame: 12 months
Health-Related Quality of Life is assessed by the SF-36 questionnaire
Secondary Outcomes
- Number of bed days for hospitalised patients(12 months)
- Number of specialist visits(12 months)
- All cause mortality(12 months)
- Number of visits to emergency department(12 months)
- Anxiety and depression status(12 months)
- Number of re-hospitalizations(12 months)