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

University Hospital of North Norway

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Behavioral: Exercise training at home; Behavioral: Telemonitoring and education/self-management

Study type: Interventional

Funder types: Other

Identifiers

NCT02258646

228919/DHE

HST1118-13 (Other Grant/Funding Number)

HST1117-13 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

Telerehabilitation

Experimental group

Description:

Exercise training at home, telemonitoring, and education/self-management

Treatment:

Behavioral: Exercise training at home

Behavioral: Telemonitoring and education/self-management

Unsupervised exercise training at home

Experimental group

Description:

Unsupervised exercise training at home

Treatment:

Behavioral: Exercise training at home

Usual care

No Intervention group

Description:

Usual care