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| ID | Type | Description | Link |
|---|---|---|---|
| HST1117-13 | Other Grant/Funding Number | Northern Norway Regional Health Authority | |
| HST1118-13 | Other Grant/Funding Number | Northern Norway Regional Health Authority |
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| Name | Class |
|---|---|
| The Research Council of Norway | OTHER |
| The Royal Norwegian Ministry of Health | OTHER |
| LHL Helse | OTHER |
| University of Tromso |
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telerehabilitation | Experimental | Exercise training at home, telemonitoring, and education/self-management |
|
| Unsupervised exercise training at home | Experimental | Unsupervised exercise training at home |
|
| Usual care | No Intervention | Usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise training at home | Behavioral |
| ||
| Telemonitoring and education/self-management |
| Measure | Description | Time Frame |
|---|---|---|
| Combined number of hospitalizations and emergency department presentations | Two years |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalizations | Two years | |
| Emergency department presentations | Two years | |
| Mortality |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in BODE Index at 6 months | 6 months | |
| Change from baseline in BODE Index at 1 year | 1 year | |
| Change from baseline in BODE Index at 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Zanaboni, PhD | University Hospital of North Norway | Principal Investigator |
| Anne E Holland, PhD | La Trobe University | Principal Investigator |
| Birthe Dinesen, PhD | Aalborg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Alfred | Melbourne | Victoria | 3181 | Australia | ||
| Sydvestjysk Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33511633 | Derived | 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. | |
| 31239657 | Derived | 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. |
| Label | URL |
|---|---|
| Study website | View source |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| OTHER |
| La Trobe University | OTHER |
| The Alfred | OTHER |
| Aalborg University | OTHER |
| Esbjerg Hospital - University Hospital of Southern Denmark | OTHER |
| Esbjerg Municipality | OTHER_GOV |
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| Behavioral |
|
| Two years |
| Time free from first hospitalization or emergency department presentation | Two years |
| Cost-effectiveness | Cost-Utility Analysis (Cost/QALY) | Two years |
| Change from baseline in COPD Assessment Test at 6 months | 6 months |
| Change from baseline in COPD Assessment Test at 1 year | One year |
| Change from baseline in COPD Assessment Test at 2 years | Two years |
| Change from baseline in EQ-5D at 6 months | Six months |
| Change from baseline in EQ-5D at 1 year | One year |
| Change from baseline in EQ-5D at 2 years | Two years |
| Change from baseline in Hospital Anxiety and Depression Scale at 6 months | Six months |
| Change from baseline in Hospital Anxiety and Depression Scale at 1 year | One Year |
| Change from baseline in Hospital Anxiety and Depression Scale at 2 years | Two years |
| Change from baseline in Generalized Self-Efficacy Scale at 6 months | Six months |
| Change from baseline in Generalized Self-Efficacy Scale at 1 year | One year |
| Change from baseline in Generalized Self-Efficacy Scale at 2 years | Two years |
| Change from baseline in 6- minute walking distance at 6 months | Six months |
| Change from baseline in 6- minute walking distance at 1 year | One year |
| Change from baseline in 6- minute walking distance at 2 years | Two years |
| Change from baseline in physical activity at 6 months | Six months |
| Change from baseline in physical activity at 1 year | One year |
| Change from baseline in physical activity at 2 years | Two years |
| Patient Global Impression of Change after 2 years | Two years |
| Hospitalizations at 1 year | One year |
| Emergency department presentations at 1 year | One year |
| Mortality at 1 year | One year |
| 2 years |
| Esbjerg |
| 6700 |
| Denmark |
| University Hospital of North Norway | Tromsø | 9038 | Norway |
| 27549782 | Derived | 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. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |