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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02258646
Recruitment Status : Completed
First Posted : October 7, 2014
Last Update Posted : April 30, 2019
Sponsor:
Collaborators:
The Research Council of Norway
The Royal Norwegian Ministry of Health
LHL Helse
University of Tromso
La Trobe University
The Alfred
Aalborg University
Sydvestjysk Hospital
Esbjerg Municipality
Information provided by (Responsible Party):
University Hospital of North Norway

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Behavioral: Exercise training at home Behavioral: Telemonitoring and education/self-management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Long-Term Integrated Telerehabilitation of COPD Patients. A Multi-Center Randomized Controlled Trial
Actual Study Start Date : October 2014
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD

Arm Intervention/treatment
Experimental: Telerehabilitation
Exercise training at home, telemonitoring, and education/self-management
Behavioral: Exercise training at home
Behavioral: Telemonitoring and education/self-management
Experimental: Unsupervised exercise training at home
Unsupervised exercise training at home
Behavioral: Exercise training at home
No Intervention: Usual care
Usual care



Primary Outcome Measures :
  1. Combined number of hospitalizations and emergency department presentations [ Time Frame: Two years ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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): NCT02258646


Locations
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Australia, Victoria
The Alfred
Melbourne, Victoria, Australia, 3181
Denmark
Sydvestjysk Hospital
Esbjerg, Denmark, 6700
Norway
University Hospital of North Norway
Tromsø, Norway, 9038
Sponsors and Collaborators
University Hospital of North Norway
The Research Council of Norway
The Royal Norwegian Ministry of Health
LHL Helse
University of Tromso
La Trobe University
The Alfred
Aalborg University
Sydvestjysk Hospital
Esbjerg Municipality
Investigators
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Principal Investigator: Paolo Zanaboni, PhD University Hospital of North Norway
Principal Investigator: Anne E Holland, PhD La Trobe University
Principal Investigator: Birthe Dinesen, PhD Aalborg University
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT02258646    
Other Study ID Numbers: 228919/DHE
HST1117-13 ( Other Grant/Funding Number: Northern Norway Regional Health Authority )
HST1118-13 ( Other Grant/Funding Number: Northern Norway Regional Health Authority )
First Posted: October 7, 2014    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Keywords provided by University Hospital of North Norway:
Exercise
Rehabilitation
Telemedicine
Treatment Outcome
Costs and Cost Analysis
Physical Therapists
Adaptation, Psychological
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive