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Home Rehabilitation Via Telemonitoring in Patients With COPD (TELECARE)

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ClinicalTrials.gov Identifier: NCT02618746
Recruitment Status : Completed
First Posted : December 1, 2015
Last Update Posted : October 19, 2016
Sponsor:
Collaborators:
National and Kapodistrian University of Athens
Greek Ministry of Development
Information provided by (Responsible Party):
IOANNIS VOGIATZIS, National and Kapodistrian University of Athens

Brief 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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Other: Telerehabilitation Other: Hospital based Rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Home Rehabilitation Via Telemonitoring of Vital Signs to Prevent Exacerbations in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Start Date : December 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A, Telerehabilitation
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.
Other: Telerehabilitation
Active Comparator: Group B, Hospital based Rehabilitation
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.
Other: Hospital based Rehabilitation
No Intervention: Group C, Usual care Group
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.



Primary Outcome Measures :
  1. Number of exacerbations [ Time Frame: 12 months ]
    Unscheduled hospital admissions due to an exacerbation including exacerbations treated at home


Secondary Outcome Measures :
  1. Functional Capacity [ Time Frame: 12 months ]
    6 min walk test

  2. Number of visits to Emergency Outpatient Clinic [ Time Frame: 12 months ]
  3. Daily physical activity levels [ Time Frame: 12 months ]
    Activity monitoring via accelerometers

  4. Quality of life and symptoms [ Time Frame: 12 months ]
    Questionaires



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

To be eligible for inclusion in this study Patients fulfil all of the following criteria:

  1. Written informed consent obtained before any assessment is performed.
  2. Male and female patients ≥ 40 years of age
  3. 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)]
  4. Optimal medical treatment according to GOLD without regular use of systemic corticosteroids
  5. 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)
  6. Absence of other significant diseases that could contribute to exercise limitation
  7. 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.

  1. 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.
  2. Respiratory diseases other than COPD (e.g. asthma)
  3. Cognitive reading impairment and/or difficulties to manage electronic devices precluding interaction with the tablet, as judged by the investigator
  4. Patients not on optimal pharmacotherapy
  5. No COPD exacerbations the year before the time entry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02618746


Sponsors and Collaborators
Thorax Research Foundation
National and Kapodistrian University of Athens
Greek Ministry of Development
Investigators
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Study Chair: Ioannis Vogiatzis, Ph.D. National and Kapodistrian University of Athens
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: IOANNIS VOGIATZIS, Associate Professor, National and Kapodistrian University of Athens
ClinicalTrials.gov Identifier: NCT02618746    
Other Study ID Numbers: 11SYN_10_1438
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: March 2016
Keywords provided by IOANNIS VOGIATZIS, National and Kapodistrian University of Athens:
Telemonitoring
Home Rehabilitation
Exacerbations
Physical Activity
COPD
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases