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Completed

NCT Number: NCT02258646

Long-Term Integrated Telerehabilitation of COPD Patients. A Multi-Center Trial

This research project aims to conduct a three-arm multi-center randomized controlled trial (RCT) on an innovative telerehabilitation intervention for patients with chronic obstructive pulmonary disease (COPD). The overall purpose of the RCT is to demonstrate whether long-term integrated telerehabilitation involving exercise training at home, telemonitoring, and education/self-management will prevent hospital readmissions, thus reducing healthcare costs, for patients with COPD, and will improve patient status and quality of life.

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Key information

Conditions

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

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Alfred, Melbourne, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of COPD
  • At least one COPD-related hospitalization or COPD-related emergency department presentation in the previous 12 months to enrollment
  • Capable to provide signed written informed consent

Exclusion criteria

  • Attendance to a rehabilitation program in the previous 6 months of enrollment
  • Participation in another study that may have an impact on the outcome of this study
  • Deemed by the health care team to be physically uncapable to perform the study procedures
  • Presence of comorbidities wich might prevent the patient from safely undertake an exercise program at home
  • Home environment not suitable for installation and use of rehabilitation and monitoring equipment (e.g. physical space, Wi-FI Internet or mobile Internet via 4G)

Treatment and study plan

Exercise training at home

Behavioral

Telemonitoring and education/self-management

Behavioral

Primary outcomes

  1. Combined number of hospitalizations and emergency department presentations

    Time frame: Two years

Secondary outcomes

  1. Hospitalizations

    Time frame: Two years

  2. Emergency department presentations

    Time frame: Two years

  3. Mortality

    Time frame: Two years

  4. Time free from first hospitalization or emergency department presentation

    Time frame: Two years

  5. Cost-effectiveness

    Time frame: Two years

    Cost-Utility Analysis (Cost/QALY)

  6. Change from baseline in COPD Assessment Test at 6 months

    Time frame: 6 months

  7. Change from baseline in COPD Assessment Test at 1 year

    Time frame: One year

  8. Change from baseline in COPD Assessment Test at 2 years

    Time frame: Two years

  9. Change from baseline in EQ-5D at 6 months

    Time frame: Six months

  10. Change from baseline in EQ-5D at 1 year

    Time frame: One year

  11. Change from baseline in EQ-5D at 2 years

    Time frame: Two years

  12. Change from baseline in Hospital Anxiety and Depression Scale at 6 months

    Time frame: Six months

  13. Change from baseline in Hospital Anxiety and Depression Scale at 1 year

    Time frame: One Year

  14. Change from baseline in Hospital Anxiety and Depression Scale at 2 years

    Time frame: Two years

  15. Change from baseline in Generalized Self-Efficacy Scale at 6 months

    Time frame: Six months

  16. Change from baseline in Generalized Self-Efficacy Scale at 1 year

    Time frame: One year

  17. Change from baseline in Generalized Self-Efficacy Scale at 2 years

    Time frame: Two years

  18. Change from baseline in 6- minute walking distance at 6 months

    Time frame: Six months

  19. Change from baseline in 6- minute walking distance at 1 year

    Time frame: One year

  20. Change from baseline in 6- minute walking distance at 2 years

    Time frame: Two years

  21. Change from baseline in physical activity at 6 months

    Time frame: Six months

  22. Change from baseline in physical activity at 1 year

    Time frame: One year

  23. Change from baseline in physical activity at 2 years

    Time frame: Two years

  24. Patient Global Impression of Change after 2 years

    Time frame: Two years

  25. Hospitalizations at 1 year

    Time frame: One year

  26. Emergency department presentations at 1 year

    Time frame: One year

  27. Mortality at 1 year

    Time frame: One year

Other outcomes

  1. Change from baseline in BODE Index at 6 months

    Time frame: 6 months

  2. Change from baseline in BODE Index at 1 year

    Time frame: 1 year

  3. Change from baseline in BODE Index at 2 years

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Collaborators

  • Aalborg University
  • Esbjerg Hospital - University Hospital of Southern Denmark
  • Esbjerg Municipality
  • LHL Helse
  • La Trobe University
  • The Alfred
  • The Research Council of Norway
  • The Royal Norwegian Ministry of Health
  • University of Tromso

Registry information

Official study title

Long-Term Integrated Telerehabilitation of COPD Patients. A Multi-Center Randomized Controlled Trial

Acronym: iTrain

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Oct 7, 2014
Registry last updated
Apr 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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