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

University Hospital of North Norway3 sites in 3 countries120 target enrollmentOctober 2014

ConditionsPulmonary Disease, Chronic Obstructive

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: University Hospital of North Norway
Enrollment: 120
Locations: 3
Primary Endpoint: Combined number of hospitalizations and emergency department presentations
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2014

End Date

December 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital of North Norway

Responsible Party

Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Combined number of hospitalizations and emergency department presentations

Time Frame: Two years

Secondary Outcomes

Change from baseline in EQ-5D at 2 years(Two years)
Change from baseline in EQ-5D at 1 year(One year)
Change from baseline in physical activity at 1 year(One year)
Change from baseline in physical activity at 2 years(Two years)
Hospitalizations at 1 year(One year)
Change from baseline in 6- minute walking distance at 2 years(Two years)
Cost-effectiveness(Two years)
Change from baseline in Generalized Self-Efficacy Scale at 2 years(Two years)
Change from baseline in Hospital Anxiety and Depression Scale at 1 year(One Year)
Change from baseline in Generalized Self-Efficacy Scale at 6 months(Six months)
Emergency department presentations at 1 year(One year)
Hospitalizations(Two years)
Mortality(Two years)
Change from baseline in COPD Assessment Test at 1 year(One year)
Change from baseline in physical activity at 6 months(Six months)
Patient Global Impression of Change after 2 years(Two years)
Emergency department presentations(Two years)
Change from baseline in EQ-5D at 6 months(Six months)
Change from baseline in Generalized Self-Efficacy Scale at 1 year(One year)
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)
Mortality at 1 year(One year)
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)
Time free from first hospitalization or emergency department presentation(Two years)
Change from baseline in COPD Assessment Test at 6 months(6 months)
Change from baseline in COPD Assessment Test at 2 years(Two years)