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

University Hospital of North Norway120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

120

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise training at homeBEHAVIORAL

Telemonitoring and education/self-managementBEHAVIORAL

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (3)

The Alfred

Melbourne, Victoria, Australia

Sydvestjysk Hospital

Esbjerg, Denmark

University Hospital of North Norway

Tromsø, Norway

Outcomes

Primary Outcomes

Combined number of hospitalizations and emergency department presentations

Time frame: Two years

Secondary Outcomes

Hospitalizations

Time frame: Two years

Emergency department presentations

Time frame: Two years

Mortality

Time frame: Two years

Time free from first hospitalization or emergency department presentation

Time frame: Two years

Cost-effectiveness

Cost-Utility Analysis (Cost/QALY)

Time frame: Two years

Change from baseline in COPD Assessment Test at 6 months

Time frame: 6 months

Change from baseline in COPD Assessment Test at 1 year

Time frame: One year

Change from baseline in COPD Assessment Test at 2 years

Time frame: Two years

Change from baseline in EQ-5D at 6 months

Time frame: Six months

Change from baseline in EQ-5D at 1 year

Time frame: One year

Change from baseline in EQ-5D at 2 years

Data from ClinicalTrials.gov

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