Home Rehabilitation Via Telemonitoring in Patients With COPD

NCT02618746 | Completed

• 1 other identifier: 11SYN_10_1438
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Telemonitoring; Home Rehabilitation; Exacerbations; Physical Activity; COPD

Outcome Measures

Primary Outcomes (1)

• Number of exacerbations

  Unscheduled hospital admissions due to an exacerbation including exacerbations treated at home

  12 months

Secondary Outcomes (4)

• Functional Capacity

  12 months

• Number of visits to Emergency Outpatient Clinic

  12 months

• Daily physical activity levels

  12 months

• Quality of life and symptoms

  12 months

Study Arms (3)

Group A, Telerehabilitation

EXPERIMENTAL

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

Group B, Hospital based Rehabilitation

ACTIVE COMPARATOR

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

Group C, Usual care Group

NO INTERVENTION

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.

Interventions

Telerehabilitation OTHER

Group A, Telerehabilitation

Hospital based Rehabilitation OTHER

Group B, Hospital based Rehabilitation

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent obtained before any assessment is performed.
• Male and female patients ≥ 40 years of age
• Diagnosis of COPD \[post-bronchodilator forced expiratory volume at one second (FEV1) \<80% predicted and FEV1/ forced vital capacity (FVC) \<75% without significant post-bronchodilator reversibility (\<10% FEV1 % predicted normal)\]
• Optimal medical treatment according to GOLD without regular use of systemic corticosteroids
• 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)
• Absence of other significant diseases that could contribute to exercise limitation
• At least 2 COPD exacerbations the year before the time entry

You may not qualify if:

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

Sponsors & Collaborators

• Thorax Research Foundation: lead
• National and Kapodistrian University of Athens: collaborator
• Greek Ministry of Development: collaborator

Related Publications (7)

• Casas A, Troosters T, Garcia-Aymerich J, Roca J, Hernandez C, Alonso A, del Pozo F, de Toledo P, Anto JM, Rodriguez-Roisin 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. doi: 10.1183/09031936.06.00063205. Epub 2006 Apr 12.

  PMID: 16611656 BACKGROUND

• 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. doi: 10.1378/chest.125.3.892.

  PMID: 15006947 BACKGROUND

• 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.

  PMID: 20970310 BACKGROUND

• Hernandez C, Alonso A, Garcia-Aymerich J, Grimsmo A, Vontetsianos T, Garcia Cuyas F, Altes AG, Vogiatzis I, Garasen 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. doi: 10.5334/ijic.2018. eCollection 2015 Jan-Mar.

  PMID: 26034465 BACKGROUND

• Poot CC, Meijer E, Kruis AL, Smidt N, Chavannes NH, Honkoop PJ. Integrated disease management interventions for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2021 Sep 8;9(9):CD009437. doi: 10.1002/14651858.CD009437.pub3.

  PMID: 34495549 DERIVED

• Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.

  PMID: 33511633 DERIVED

• Vasilopoulou M, Papaioannou AI, Kaltsakas G, Louvaris Z, Chynkiamis N, Spetsioti S, Kortianou E, Genimata SA, Palamidas A, Kostikas K, Koulouris NG, Vogiatzis I. Home-based maintenance tele-rehabilitation reduces the risk for acute exacerbations of COPD, hospitalisations and emergency department visits. Eur Respir J. 2017 May 25;49(5):1602129. doi: 10.1183/13993003.02129-2016. Print 2017 May.

  PMID: 28546268 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Ioannis Vogiatzis, Ph.D.

  National and Kapodistrian University of Athens

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 28, 2015
• First Posted: December 1, 2015
• Study Start: December 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2016
• Last Updated: October 19, 2016

Record last verified: 2016-03