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

Not Applicable

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Behavioral: Exercise training at home; Behavioral: Telemonitoring and education/self-management

• Registration Number: NCT02258646
• Lead Sponsor: University Hospital of North Norway

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-02
• Study First Submitted QC: 2014-10-06
• Study First Posted: 2014-10-07
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-26
• Last Update Posted: 2019-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telerehabilitation	Exercise training at home	Exercise training at home, telemonitoring, and education/self-management
Unsupervised exercise training at home	Exercise training at home	Unsupervised exercise training at home
Telerehabilitation	Telemonitoring and education/self-management	Exercise training at home, telemonitoring, and education/self-management

Primary Outcome Measures

Name	Time	Method
Combined number of hospitalizations and emergency department presentations	Two years

Secondary Outcome Measures

Name	Time	Method
Change from baseline in 6- minute walking distance at 2 years	Two years
Cost-effectiveness	Two years	Cost-Utility Analysis (Cost/QALY)
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 EQ-5D at 2 years	Two years
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
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
Change from baseline in EQ-5D 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
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

Trial Locations

Locations (3)

The Alfred; 🇦🇺 Melbourne, Victoria, Australia

University Hospital of North Norway; 🇳🇴 Tromsø, Norway

Sydvestjysk Hospital; 🇩🇰 Esbjerg, Denmark