Chronic Obstructive Pulmonary Disease Clinical Trial
— TELECAREOfficial title:
Home Rehabilitation Via Telemonitoring of Vital Signs to Prevent Exacerbations in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Verified date | March 2016 |
Source | Thorax Research Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Hellenic Data Protection Authority |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | July 2016 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Thorax Research Foundation | Greek Ministry of Development, National and Kapodistrian University of Athens |
Casas A, Troosters T, Garcia-Aymerich J, Roca J, Hernández C, Alonso A, del Pozo F, de Toledo P, Antó JM, Rodríguez-Roisín R, Decramer M; members of the CHRONIC Project. Integrated care prevents hospitalisations for exacerbations in COPD patients. Eur Respir J. 2006 Jul;28(1):123-30. Epub 2006 Apr 12. — View Citation
Geitona M, Hatzikou M, Steiropoulos P, Alexopoulos EC, Bouros D. The cost of COPD exacerbations: a university hospital--based study in Greece. Respir Med. 2011 Mar;105(3):402-9. doi: 10.1016/j.rmed.2010.09.020. — View Citation
Hernández C, Alonso A, Garcia-Aymerich J, Grimsmo A, Vontetsianos T, García Cuyàs F, Altes AG, Vogiatzis I, Garåsen H, Pellise L, Wienhofen L, Cano I, Meya M, Moharra M, Martinez JI, Escarrabill J, Roca J. Integrated care services: lessons learned from the deployment of the NEXES project. Int J Integr Care. 2015 Mar 30;15:e006. eCollection 2015 Jan-Mar. — View Citation
Tzanakis N, Anagnostopoulou U, Filaditaki V, Christaki P, Siafakas N; COPD group of the Hellenic Thoracic Society. Prevalence of COPD in Greece. Chest. 2004 Mar;125(3):892-900. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of exacerbations | Unscheduled hospital admissions due to an exacerbation including exacerbations treated at home | 12 months | No |
Secondary | Functional Capacity | 6 min walk test | 12 months | No |
Secondary | Number of visits to Emergency Outpatient Clinic | 12 months | No | |
Secondary | Daily physical activity levels | Activity monitoring via accelerometers | 12 months | No |
Secondary | Quality of life and symptoms | Questionaires | 12 months | No |
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