Home Rehabilitation Via Telemonitoring in Patients With COPD

COPD is an important health problem in Greece as the average prevalence of COPD in people > 35 years old is 8.4% (i.e.: approximately 350.000 citizens) (Tzanakis et al., 2004). Hospitalization attributed to severe exacerbations is the major cost driver of COPD. A study in Northern Greece revealed that mean actual cost per severe exacerbation of COPD is €1711, whilst only the amount of €621 is reimbursed by social security funds (Geitona et al., 2011). The observed price discrepancies between the actual and the nominal cost per patient, undoubtedly increases public debt especially when considering that patients with severe COPD suffer from acute exacerbations twice or three times per year.

Accordingly, there is urgent need to prevent exacerbations and subsequent hospitalizations in Greece. International evidence supports the concept that telemonitoring has a key role to play in systemic improvements to healthcare by reducing unplanned hospital admissions, hospital length of stay and the use of health care services, thereby making best use of scarce clinical resources and empowering individual patients. Home telemonitoring of chronic lung diseases appears as a promising patient management approach that could potentially produce accurate and reliable data, empower patients, influence their attitudes and behaviour, and improve patients medical conditions.

However, the scientific evidence in support of home telemonitoring is still weak and inconsistent, which highlights the need for more research, particularly in relation to the patient-level benefits, associated with these technologies. Furthermore, although, economic viability of telemonitoring has been observed in very few studies, in most cases no in-depth cost-minimization analyses were performed (Casas et al., 2006; Hernandez et al., 2015). Accordingly, there is a need of studies to accumulate evidence related to the interaction between the clinical effects of telemonitoring, its cost effectiveness, the impact on services utilization, and acceptance by health care providers. The project looks into the sustainability of patient telemonitoring services implemented by a private health care enterprise, namely the Filoktitis Rehabilitation Centre and its clinical effectiveness compared to a long term program of hospital-based rehabilitation (at Athens University 1st Department of Respiratory Medicine) not requiring home telemonitoring. The proposed strategy will allow the analysis and evaluation of reimbursement schemes and the design of appropriate business models.

The main idea is to initially (8-weeks) teach COPD patients techniques of self-management and improve their functional capacity by regular exercise training taking place at two different rehabilitation centres (one state hospital: Athens University Clinic of Respiratory Medicine, and one private hospital: Filoktitis Rehabilitation Centre) and subsequently either have the patients visiting the State University Hospital twice weekly for wellness and rehabilitation sessions and for regular checking of their clinical condition for 12 months or in the case of Filoktitis refer patients home to live independently whilst remotely monitoring the course of a number of vital signs that alert the physician when an exacerbation is eminent. (i.e., prematurely recognize symptoms of exacerbation). The initial 8-week sessions of rehabilitation takes place at both the University Hospital Clinic and at Filoktitis rehabilitation centre, whilst home monitoring will be implemented only to those who complete the initial 8-week phase at Filoktitis Rehabilitation Centre for a subsequent period of 12 months. Patients who complete the initial 8-week program at the University Clinic will keep visiting the centre twice weekly for 12 months. The ultimate objective of this project is to identify, in terms of health status outcomes, patient compliance and cost effectiveness, whether remote monitoring and management of patients by professionals at the private rehabilitation centre is superior to that not involving telemonitoring but regular visits to the University Hospital Clinic.

The aim of the proposed project in terms of specific patient outcome measures (namely annual rate of hospital admissions due to an exacerbation and exacerbations treated at home, emergency room visits, use of health care resources, quality of life, functional capacity and daily levels of physical activity) to test the efficacy of wireless systems for patient's home self-monitoring when this service is delivered remotely by a private rehabilitation centre compared to close monitoring of patients through regular visits to the University Hospital Clinic.

The hypothesis to be tested will be that once the technology and knowledge is transferred to a private rehabilitation centre, patient follow-up and early prevention of exacerbations will not differ when patients are controlled remotely via home telemonitoring services compared to the management of patients at centralized Hospital level, since in the case of the latter type of service there are difficulties for elderly and frail patients to regularly visit the Hospital.

Study design: One hundred fifty (150) clinically stable patients classified by GOLD as stages II III and IV are recruited from the University Hospital Outpatient Clinic and the Filoktitis Medical Centre.

The study is conducted as a randomized controlled trial blindly assigned using a set of computer-generated random numbers to home care (group A, Telerehabilitation group: controlled by Filoktitis rehabilitation centre) or group B (Hospital based Rehabilitation supervised by the University hospital personnel) and a third group that will receive usual care (group C, usual care: control group). Prior to recruitment COPD patients initially complete a multidisciplinary intense Pulmonary Rehabilitation Program lasting for 8 weeks either at Filoktitis rehabilitation centre or at the University clinic rehabilitation centre at Sotiria Hospital (1st Department of Respiratory Medicine) to improve the functional capacity and quality of life. Thereafter patients assigned into group A (n = 50) are monitored at home for 12 months or for Group B (n= 50) followed by the University clinic professional twice weekly where visits to the hospital are scheduled for 12 months to undertake physiotherapy, dietary and psychological advice and exercise training sessions. The control group (C: = 50 patients) follows the usual care treatment not involving maintenance hospital rehabilitation sessions or home telemonitoring of vital signs.

The home care/rehabilitative program includes 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 monthly home visits of physiotherapists, dietician and physician with remote connection as a response to possible incidents; f) remote monitoring selectively and temporarily. The home care program will be performed by staff employed by Filoktitis rehabilitation centre.

Study protocol: On a daily basis, patients being recruited to the home care program (Telerehabilitation, group A) take one or more of their own vital sign measurements using wireless devices in their home. They may also manually enter some measurements into a tablet. Results are automatically transmitted from the tablet (via mobile communication network) to a secure web-based server platform, the in-home communication device that also prompts patients to answer clinician-directed health and risk assessment survey questions. A care management team based at Filoktitis (nurse or physician) reviews each patient's information on a web-based clinical review platform, and sends an alert to the patient's doctor when a vital sign measurement or survey response falls outside established limits. In addition to monitoring the tell-tale symptoms of decline - such as abnormal weight gain, increased blood pressure, shortness of breath, fatigue, or oedema, fever, cough - the system also triggers automated health assessments. Patients in group A are also given tasks to exercise regularly at home as well as they are remotely provided with dietary and psychological advice. Patients assigned to the hospital based rehabilitation program (group B) visit the hospital twice weekly for 12 months in order to participate to a multidisciplinary rehabilitation program including exercise, physiotherapy dietary and psychological advice by the staff of the rehabilitation centre based at the University clinic.

Outcomes assessed at 12 months follow up for all 3 groups: i) state of health evaluated with standardised questionnaires; ii) number of emergency room visits and unscheduled hospital admissions due to any cause; iii) annual rate of admitted days; iv) functional capacity); v) daily symptoms; vi) daily physical activity; vii) health-related quality of life. Frequency of assessment: outcomes will be assessed at baseline (prior to joining the initial 8 week rehabilitation program), at 6 months and 12 months following completion of the initial 8-weeks rehabilitation program.