Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Exercise, Rehabilitation, Telemedicine, Treatment Outcome, Costs and Cost Analysis, Physical Therapists, Adaptation, Psychological
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.
Interventions
BEHAVIORALExercise training at home
BEHAVIORALTelemonitoring and education/self-management
Sponsors
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
University Hospital of North Norway
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined number of hospitalizations and emergency department presentations | Two years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Hospital Anxiety and Depression Scale at 1 year | One Year | — |
| Hospitalizations at 1 year | One year | — |
| Emergency department presentations at 1 year | One year | — |
| Mortality at 1 year | One year | — |
| Hospitalizations | Two years | — |
| Emergency department presentations | Two years | — |
| Mortality | Two years | — |
| Time free from first hospitalization or emergency department presentation | Two years | — |
| Cost-effectiveness | Two years | Cost-Utility Analysis (Cost/QALY) |
| 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 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 | — |
Other
| Measure | Time frame |
|---|---|
| Change from baseline in BODE Index at 2 years | 2 years |
| Change from baseline in BODE Index at 6 months | 6 months |
| Change from baseline in BODE Index at 1 year | 1 year |
Countries
Australia, Denmark, Norway
Outcome results
None listed