Pulmonary Disease, Chronic ObstructiveiTrainNCT02258646
Long-Term Integrated Telerehabilitation of COPD Patients. A Multi-Center Trial
A study testing Exercise training at home and Telemonitoring and education/self-management in people with Pulmonary Disease, Chronic Obstructive, run by University Hospital of North Norway at 3 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Exercise training at home and Telemonitoring and education/self-management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Oct 2014to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Long-Term Integrated Telerehabilitation of COPD Patients. A Multi-Center Randomized Controlled 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Exercise training at home, Telemonitoring and education/self-management
- Keywords
- Exercise, Rehabilitation, Telemedicine, Treatment Outcome, Costs and Cost Analysis, Physical Therapists, Adaptation, Psychological
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise training at homeBehavioural
Telemonitoring and education/self-managementBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation | Experimental | Exercise training at home, telemonitoring, and education/self-management Receives: Behavioral: Exercise training at home; Behavioral: Telemonitoring and education/self-management |
| Unsupervised exercise training at home | Experimental | Unsupervised exercise training at home Receives: Behavioral: Exercise training at home |
| Usual care | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined number of hospitalizations and emergency department presentations
Measured: Two years
Secondary outcomes (27)
Hospitalizations
Measured: Two years
Emergency department presentations
Measured: Two years
Mortality
Measured: Two years
Time free from first hospitalization or emergency department presentation
Measured: Two years
Cost-effectiveness
Cost-Utility Analysis (Cost/QALY)
Measured: Two years
Change from baseline in COPD Assessment Test at 6 months
Measured: 6 months
Change from baseline in COPD Assessment Test at 1 year
Measured: One year
Change from baseline in COPD Assessment Test at 2 years
Measured: Two years
Change from baseline in EQ-5D at 6 months
Measured: Six months
Change from baseline in EQ-5D at 1 year
Measured: One year
Change from baseline in EQ-5D at 2 years
Measured: Two years
Change from baseline in Hospital Anxiety and Depression Scale at 6 months
Measured: Six months
Change from baseline in Hospital Anxiety and Depression Scale at 1 year
Measured: One Year
Change from baseline in Hospital Anxiety and Depression Scale at 2 years
Measured: Two years
Change from baseline in Generalized Self-Efficacy Scale at 6 months
Measured: Six months
Change from baseline in Generalized Self-Efficacy Scale at 1 year
Measured: One year
Change from baseline in Generalized Self-Efficacy Scale at 2 years
Measured: Two years
Change from baseline in 6- minute walking distance at 6 months
Measured: Six months
Change from baseline in 6- minute walking distance at 1 year
Measured: One year
Change from baseline in 6- minute walking distance at 2 years
Measured: Two years
Change from baseline in physical activity at 6 months
Measured: Six months
Change from baseline in physical activity at 1 year
Measured: One year
Change from baseline in physical activity at 2 years
Measured: Two years
Patient Global Impression of Change after 2 years
Measured: Two years
Hospitalizations at 1 year
Measured: One year
Emergency department presentations at 1 year
Measured: One year
Mortality at 1 year
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, The Royal Norwegian Ministry of Health, LHL Helse, University of Tromso, La Trobe University, The Alfred, Aalborg University, Esbjerg Hospital - University Hospital of Southern Denmark, Esbjerg Municipality
- Responsible party
- Sponsor
- Investigators
- Paolo Zanaboni, PhD, Principal investigator, University Hospital of North NorwayAnne E Holland, PhD, Principal investigator, La Trobe UniversityBirthe Dinesen, PhD, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258646
- Sponsor's protocol ID
- 228919/DHE
- Other IDs
- HST1117-13, HST1118-13
- Acronym
- iTrain
- Status last verified
- Apr 2019
- First submitted
- 2 Oct 2014
- Last updated
- 30 Apr 2019
- Results posted
- No
Publications
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.
PubMed 33511633Hoaas 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.
PubMed 31239657Zanaboni 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.
PubMed 27549782
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Integrated Telerehabilitation of COPD Patients. A Multi-Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02258646
- Acronym / sponsor ID
- iTrain / 228919/DHE
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Exercise, Rehabilitation, Telemedicine, Treatment Outcome, Costs and Cost Analysis, Physical Therapists, Adaptation, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- The Research Council of Norway, The Royal Norwegian Ministry of Health, LHL Helse, University of Tromso, La Trobe University, The Alfred, Aalborg University, Esbjerg Hospital - University Hospital of Southern Denmark, Esbjerg Municipality
- Study start
- Oct 2014 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 7 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation | Experimental | Behavioral: Exercise training at home, Behavioral: Telemonitoring and education/self-managementExercise training at home, telemonitoring, and education/self-management |
| Unsupervised exercise training at home | Experimental | Behavioral: Exercise training at homeUnsupervised exercise training at home |
| Usual care | No intervention | –Usual care |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise training at home | Behavioural | Telerehabilitation, Unsupervised exercise training at home |
| Telemonitoring and education/self-management | Behavioural | Telerehabilitation |
Primary outcome
Combined number of hospitalizations and emergency department presentations
Time frame: Two years
27 secondary outcomes
Hospitalizations
Time frame: Two years
Emergency department presentations
Time frame: Two years
Mortality
Time frame: Two years
Time free from first hospitalization or emergency department presentation
Time frame: Two years
Cost-effectiveness
Time frame: Two years
Change from baseline in COPD Assessment Test at 6 months
Time frame: 6 months
Change from baseline in COPD Assessment Test at 1 year
Time frame: One year
Change from baseline in COPD Assessment Test at 2 years
Time frame: Two years
Change from baseline in EQ-5D at 6 months
Time frame: Six months
Change from baseline in EQ-5D at 1 year
Time frame: One year
Change from baseline in EQ-5D at 2 years
Time frame: Two years
Change from baseline in Hospital Anxiety and Depression Scale at 6 months
Time frame: Six months
Change from baseline in Hospital Anxiety and Depression Scale at 1 year
Time frame: One Year
Change from baseline in Hospital Anxiety and Depression Scale at 2 years
Time frame: Two years
Change from baseline in Generalized Self-Efficacy Scale at 6 months
Time frame: Six months
Change from baseline in Generalized Self-Efficacy Scale at 1 year
Time frame: One year
Change from baseline in Generalized Self-Efficacy Scale at 2 years
Time frame: Two years
Change from baseline in 6- minute walking distance at 6 months
Time frame: Six months
Change from baseline in 6- minute walking distance at 1 year
Time frame: One year
Change from baseline in 6- minute walking distance at 2 years
Time frame: Two years
Change from baseline in physical activity at 6 months
Time frame: Six months
Change from baseline in physical activity at 1 year
Time frame: One year
Change from baseline in physical activity at 2 years
Time frame: Two years
Patient Global Impression of Change after 2 years
Time frame: Two years
Hospitalizations at 1 year
Time frame: One year
Emergency department presentations at 1 year
Time frame: One year
Mortality at 1 year
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Derived from this study: PubMed 33511633Cox 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.
- Derived from this study: PubMed 31239657Hoaas 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.
- Derived from this study: PubMed 27549782Zanaboni 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.
- Study websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Zanaboni, PhD principal investigator
University Hospital of North Norway
Anne E Holland, PhD principal investigator
La Trobe University
Birthe Dinesen, PhD principal investigator
Aalborg University
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training at home and Telemonitoring and education/self-management in people with Pulmonary Disease, Chronic Obstructive, run by University Hospital of North Norway at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, Denmark, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined number of hospitalizations and emergency department presentations (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02258646, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019.