Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Home Rehabilitation Via Telemonitoring of Vital Signs to Prevent Exacerbations in Patients With Chronic Obstructive Pulmonary Disease (COPD)
COPD is the fourth leading cause of death in the world and is the only one of the top five
illnesses whose death rate is still increasing. It is mainly caused by smoking. Greece has a
higher prevalence and death rate for COPD than many other countries in Europe. The disease
is incurable so treatment is aimed at alleviating symptoms and slowing progression. Despite
maximal medication and strategies such as pulmonary rehabilitation and home nurse support,
many patients remain vulnerable, socially isolated and report difficulty in accessing their
local health services. Research has shown that patients have worsening symptoms for an
average of three to four days before they are admitted to hospital with an exacerbation of
COPD. This suggests a window of opportunity to intervene. Early warning and contact via
innovative technology may treat symptoms earlier, improve patient confidence / quality of
life and simultaneously reduce health care visits or admissions. However, there is a large
gap between the postulated and empirically demonstrated benefits of electronic Health
Technologies. In addition, there is a lack of robust research on the risks of implementing
these technologies and their cost-effectiveness has yet to be demonstrated, despite being
frequently promoted by policymakers as if this was a given issue. In addition, the
evidence-base for telehealth is not well-reported in peer reviewed journals and hence there
continue to be difficulties experienced in convincing clinicians, hospital managers and
stakeholders that investment in such technologies will enable reductions in other aspects of
healthcare delivery over time.
This project attempts to provide robust justification of the effectiveness of
telerehabilitation by the implementation of a randomized controlled trial blindly assigning
COPD patients to: i) a home care and telerehabilitation group remotely monitored by a
specialised private health care centre (Filoktitis - group A) or ii) a hospital-based
rehabilitation group managed at a regular base through weekly visits by personnel at a state
University rehabilitation centre (group B). iii) A third group that receives usual care
(group C: control group; i.e.: neither home monitoring nor hospital based rehabilitation) is
also included.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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