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

Study Overview
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Brief Summary
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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.

Official Title
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Long-Term Integrated Telerehabilitation of COPD Patients. A Multi-Center Randomized Controlled Trial

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Behavioral: Exercise training at home
* Behavioral: Telemonitoring and education/self-management


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telerehabilitation<br>Exercise training at home, telemonitoring, and education/self-management | Behavioral: Exercise training at home<br> <br> Behavioral: Telemonitoring and education/self-management<br> <br> |
| Experimental: Unsupervised exercise training at home<br>Unsupervised exercise training at home | Behavioral: Exercise training at home<br> <br> |
| No Intervention: Usual care<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined number of hospitalizations and emergency department presentations |  | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalizations |  | Two years | 
| Emergency department presentations |  | Two years | 
| Mortality |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Rehabilitation, Telemedicine, Treatment Outcome, Costs and Cost Analysis, Physical Therapists, Adaptation, Psychological