Home Rehabilitation Via Telemonitoring in Patients With COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Telerehabilitation; Hospital based Rehabilitation
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Telemonitoring; Home Rehabilitation; Exacerbations; Physical Activity; COPD