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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Exercise training at home
Telemonitoring and education/self-management
Sponsored by
University Hospital of North Norway
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pulmonary Disease, Chronic Obstructive focused on measuring Exercise, Rehabilitation, Telemedicine, Treatment Outcome, Costs and Cost Analysis, Physical Therapists, Adaptation, Psychological

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The Alfred
  • Sydvestjysk Hospital
  • University Hospital of North Norway

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Telerehabilitation

Unsupervised exercise training at home

Usual care

Arm Description

Exercise training at home, telemonitoring, and education/self-management

Unsupervised exercise training at home

Usual care

Outcomes

Primary Outcome Measures

Combined number of hospitalizations and emergency department presentations

Secondary Outcome Measures

Hospitalizations
Emergency department presentations
Mortality
Time free from first hospitalization or emergency department presentation
Cost-effectiveness
Cost-Utility Analysis (Cost/QALY)
Change from baseline in COPD Assessment Test at 6 months
Change from baseline in COPD Assessment Test at 1 year
Change from baseline in COPD Assessment Test at 2 years
Change from baseline in EQ-5D at 6 months
Change from baseline in EQ-5D at 1 year
Change from baseline in EQ-5D at 2 years
Change from baseline in Hospital Anxiety and Depression Scale at 6 months
Change from baseline in Hospital Anxiety and Depression Scale at 1 year
Change from baseline in Hospital Anxiety and Depression Scale at 2 years
Change from baseline in Generalized Self-Efficacy Scale at 6 months
Change from baseline in Generalized Self-Efficacy Scale at 1 year
Change from baseline in Generalized Self-Efficacy Scale at 2 years
Change from baseline in 6- minute walking distance at 6 months
Change from baseline in 6- minute walking distance at 1 year
Change from baseline in 6- minute walking distance at 2 years
Change from baseline in physical activity at 6 months
Change from baseline in physical activity at 1 year
Change from baseline in physical activity at 2 years
Patient Global Impression of Change after 2 years
Hospitalizations at 1 year
Emergency department presentations at 1 year
Mortality at 1 year

Full Information

First Posted
October 2, 2014
Last Updated
April 26, 2019
Sponsor
University Hospital of North Norway
Collaborators
The Research Council of Norway, The Royal Norwegian Ministry of Health, LHL Helse, University of Tromso, La Trobe University, The Alfred, Aalborg University, Hospital of South West Jutland, Esbjerg Municipality
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1. Study Identification

Unique Protocol Identification Number
NCT02258646
Brief Title
Long-Term Integrated Telerehabilitation of COPD Patients. A Multi-Center Trial
Acronym
iTrain
Official Title
Long-Term Integrated Telerehabilitation of COPD Patients. A Multi-Center Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of North Norway
Collaborators
The Research Council of Norway, The Royal Norwegian Ministry of Health, LHL Helse, University of Tromso, La Trobe University, The Alfred, Aalborg University, Hospital of South West Jutland, Esbjerg Municipality

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Exercise, Rehabilitation, Telemedicine, Treatment Outcome, Costs and Cost Analysis, Physical Therapists, Adaptation, Psychological

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation
Arm Type
Experimental
Arm Description
Exercise training at home, telemonitoring, and education/self-management
Arm Title
Unsupervised exercise training at home
Arm Type
Experimental
Arm Description
Unsupervised exercise training at home
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Exercise training at home
Intervention Type
Behavioral
Intervention Name(s)
Telemonitoring and education/self-management
Primary Outcome Measure Information:
Title
Combined number of hospitalizations and emergency department presentations
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Hospitalizations
Time Frame
Two years
Title
Emergency department presentations
Time Frame
Two years
Title
Mortality
Time Frame
Two years
Title
Time free from first hospitalization or emergency department presentation
Time Frame
Two years
Title
Cost-effectiveness
Description
Cost-Utility Analysis (Cost/QALY)
Time Frame
Two years
Title
Change from baseline in COPD Assessment Test at 6 months
Time Frame
6 months
Title
Change from baseline in COPD Assessment Test at 1 year
Time Frame
One year
Title
Change from baseline in COPD Assessment Test at 2 years
Time Frame
Two years
Title
Change from baseline in EQ-5D at 6 months
Time Frame
Six months
Title
Change from baseline in EQ-5D at 1 year
Time Frame
One year
Title
Change from baseline in EQ-5D at 2 years
Time Frame
Two years
Title
Change from baseline in Hospital Anxiety and Depression Scale at 6 months
Time Frame
Six months
Title
Change from baseline in Hospital Anxiety and Depression Scale at 1 year
Time Frame
One Year
Title
Change from baseline in Hospital Anxiety and Depression Scale at 2 years
Time Frame
Two years
Title
Change from baseline in Generalized Self-Efficacy Scale at 6 months
Time Frame
Six months
Title
Change from baseline in Generalized Self-Efficacy Scale at 1 year
Time Frame
One year
Title
Change from baseline in Generalized Self-Efficacy Scale at 2 years
Time Frame
Two years
Title
Change from baseline in 6- minute walking distance at 6 months
Time Frame
Six months
Title
Change from baseline in 6- minute walking distance at 1 year
Time Frame
One year
Title
Change from baseline in 6- minute walking distance at 2 years
Time Frame
Two years
Title
Change from baseline in physical activity at 6 months
Time Frame
Six months
Title
Change from baseline in physical activity at 1 year
Time Frame
One year
Title
Change from baseline in physical activity at 2 years
Time Frame
Two years
Title
Patient Global Impression of Change after 2 years
Time Frame
Two years
Title
Hospitalizations at 1 year
Time Frame
One year
Title
Emergency department presentations at 1 year
Time Frame
One year
Title
Mortality at 1 year
Time Frame
One year
Other Pre-specified Outcome Measures:
Title
Change from baseline in BODE Index at 6 months
Time Frame
6 months
Title
Change from baseline in BODE Index at 1 year
Time Frame
1 year
Title
Change from baseline in BODE Index at 2 years
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Zanaboni, PhD
Organizational Affiliation
University Hospital of North Norway
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anne E Holland, PhD
Organizational Affiliation
La Trobe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Birthe Dinesen, PhD
Organizational Affiliation
Aalborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Alfred
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Sydvestjysk Hospital
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
University Hospital of North Norway
City
Tromsø
ZIP/Postal Code
9038
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
33511633
Citation
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.
Results Reference
derived
PubMed Identifier
31239657
Citation
Hoaas H, Zanaboni P, Hjalmarsen A, Morseth B, Dinesen B, Burge AT, Cox NS, Holland AE. Seasonal variations in objectively assessed physical activity among people with COPD in two Nordic countries and Australia: a cross-sectional study. Int J Chron Obstruct Pulmon Dis. 2019 Jun 5;14:1219-1228. doi: 10.2147/COPD.S194622. eCollection 2019.
Results Reference
derived
PubMed Identifier
27549782
Citation
Zanaboni P, Dinesen B, Hjalmarsen A, Hoaas H, Holland AE, Oliveira CC, Wootton R. Long-term integrated telerehabilitation of COPD Patients: a multicentre randomised controlled trial (iTrain). BMC Pulm Med. 2016 Aug 22;16(1):126. doi: 10.1186/s12890-016-0288-z.
Results Reference
derived
Links:
URL
https://ehealthresearch.no/en/projects/itrain-study
Description
Study website

Learn more about this trial

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

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