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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02258646




Registration number
NCT02258646
Ethics application status
Date submitted
2/10/2014
Date registered
7/10/2014
Date last updated
30/04/2019

Titles & IDs
Public title
Long-Term Integrated Telerehabilitation of COPD Patients. A Multi-Center Trial
Scientific title
Long-Term Integrated Telerehabilitation of COPD Patients. A Multi-Center Randomized Controlled Trial
Secondary ID [1] 0 0
HST1117-13
Secondary ID [2] 0 0
228919/DHE
Universal Trial Number (UTN)
Trial acronym
iTrain
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Exercise training at home
Behaviour - Telemonitoring and education/self-management

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

Experimental: Unsupervised exercise training at home - Unsupervised exercise training at home

No Intervention: Usual care - Usual care


Behaviour: Exercise training at home


Behaviour: Telemonitoring and education/self-management


Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Combined number of hospitalizations and emergency department presentations
Timepoint [1] 0 0
Two years
Secondary outcome [1] 0 0
Hospitalizations
Timepoint [1] 0 0
Two years
Secondary outcome [2] 0 0
Emergency department presentations
Timepoint [2] 0 0
Two years
Secondary outcome [3] 0 0
Mortality
Timepoint [3] 0 0
Two years
Secondary outcome [4] 0 0
Time free from first hospitalization or emergency department presentation
Timepoint [4] 0 0
Two years
Secondary outcome [5] 0 0
Cost-effectiveness - Cost-Utility Analysis (Cost/QALY)
Timepoint [5] 0 0
Two years
Secondary outcome [6] 0 0
Change from baseline in COPD Assessment Test at 6 months
Timepoint [6] 0 0
6 months
Secondary outcome [7] 0 0
Change from baseline in COPD Assessment Test at 1 year
Timepoint [7] 0 0
One year
Secondary outcome [8] 0 0
Change from baseline in COPD Assessment Test at 2 years
Timepoint [8] 0 0
Two years
Secondary outcome [9] 0 0
Change from baseline in EQ-5D at 6 months
Timepoint [9] 0 0
Six months
Secondary outcome [10] 0 0
Change from baseline in EQ-5D at 1 year
Timepoint [10] 0 0
One year
Secondary outcome [11] 0 0
Change from baseline in EQ-5D at 2 years
Timepoint [11] 0 0
Two years
Secondary outcome [12] 0 0
Change from baseline in Hospital Anxiety and Depression Scale at 6 months
Timepoint [12] 0 0
Six months
Secondary outcome [13] 0 0
Change from baseline in Hospital Anxiety and Depression Scale at 1 year
Timepoint [13] 0 0
One Year
Secondary outcome [14] 0 0
Change from baseline in Hospital Anxiety and Depression Scale at 2 years
Timepoint [14] 0 0
Two years
Secondary outcome [15] 0 0
Change from baseline in Generalized Self-Efficacy Scale at 6 months
Timepoint [15] 0 0
Six months
Secondary outcome [16] 0 0
Change from baseline in Generalized Self-Efficacy Scale at 1 year
Timepoint [16] 0 0
One year
Secondary outcome [17] 0 0
Change from baseline in Generalized Self-Efficacy Scale at 2 years
Timepoint [17] 0 0
Two years
Secondary outcome [18] 0 0
Change from baseline in 6- minute walking distance at 6 months
Timepoint [18] 0 0
Six months
Secondary outcome [19] 0 0
Change from baseline in 6- minute walking distance at 1 year
Timepoint [19] 0 0
One year
Secondary outcome [20] 0 0
Change from baseline in 6- minute walking distance at 2 years
Timepoint [20] 0 0
Two years
Secondary outcome [21] 0 0
Change from baseline in physical activity at 6 months
Timepoint [21] 0 0
Six months
Secondary outcome [22] 0 0
Change from baseline in physical activity at 1 year
Timepoint [22] 0 0
One year
Secondary outcome [23] 0 0
Change from baseline in physical activity at 2 years
Timepoint [23] 0 0
Two years
Secondary outcome [24] 0 0
Patient Global Impression of Change after 2 years
Timepoint [24] 0 0
Two years
Secondary outcome [25] 0 0
Hospitalizations at 1 year
Timepoint [25] 0 0
One year
Secondary outcome [26] 0 0
Emergency department presentations at 1 year
Timepoint [26] 0 0
One year
Secondary outcome [27] 0 0
Mortality at 1 year
Timepoint [27] 0 0
One year

Eligibility
Key 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
Minimum age
40 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Supportive Care
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Esbjerg
Country [2] 0 0
Norway
State/province [2] 0 0
Tromsø

Funding & Sponsors
Primary sponsor type
Other
Name
University Hospital of North Norway
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Research Council of Norway
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
The Royal Norwegian Ministry of Health
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
LHL Helse
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University of Tromso
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
La Trobe University
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
The Alfred
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Aalborg University
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Sydvestjysk Hospital
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Esbjerg Municipality
Address [9] 0 0
Country [9] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02258646
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paolo Zanaboni, PhD
Address 0 0
University Hospital of North Norway
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications