Home Rehabilitation Via Telemonitoring in Patients With COPD (TELECARE)
Chronic Obstructive Pulmonary Disease
About this trial
This is an interventional health services research trial for Chronic Obstructive Pulmonary Disease focused on measuring Telemonitoring, Home Rehabilitation, Exacerbations, Physical Activity, COPD
Eligibility Criteria
Inclusion Criteria:
To be eligible for inclusion in this study Patients fulfil all of the following criteria:
- Written informed consent obtained before any assessment is performed.
- Male and female patients ≥ 40 years of age
- Diagnosis of COPD [post-bronchodilator forced expiratory volume at one second (FEV1) <80% predicted and FEV1/ forced vital capacity (FVC) <75% without significant post-bronchodilator reversibility (<10% FEV1 % predicted normal)]
- Optimal medical treatment according to GOLD without regular use of systemic corticosteroids
- Current or ex-smokers with a smoking history equivalent to at least 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year)
- Absence of other significant diseases that could contribute to exercise limitation
- At least 2 COPD exacerbations the year before the time entry
Exclusion Criteria:
Patients fulfilling any of the following criteria are not eligible for inclusion in this study. No additional exclusions are applied by the investigator, in order to ensure that the study population will be representative of all eligible patients.
- Orthopedic, neurological or other complaints that significantly impair normal biomechanical movement patterns, as judged by the investigator. Specifically if the patients' condition/ co-morbidities are such that physical activity cannot be increased.
- Respiratory diseases other than COPD (e.g. asthma)
- Cognitive reading impairment and/or difficulties to manage electronic devices precluding interaction with the tablet, as judged by the investigator
- Patients not on optimal pharmacotherapy
- No COPD exacerbations the year before the time entry
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
No Intervention
Group A, Telerehabilitation
Group B, Hospital based Rehabilitation
Group C, Usual care Group
The 12-month home care/rehabilitative program will include the following components: a) individualized action plan; b) educational session on self management; c) physical exercise sessions to remote monitoring; d) access to the call centre; e) professional weekly calls by physiotherapists, dietician and physician with remote connection as a response to possible incidents; f) remote monitoring selectively and temporarily.
Patients assigned to the hospital based program will visit the hospital twice weekly for 12 months in order to participate in a multidisciplinary rehabilitation program including exercise, physiotherapy dietary and psychological advice by the staff of the rehabilitation centre based at the University clinic.
The control group will follow the usual care not involving the initial 8-week rehabilitation program neither maintenance hospital rehabilitation sessions or home telemonitoring of vital signs.