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

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

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 Overview

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

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3181
      • The Alfred
• Denmark
  • Esbjerg, Denmark, 6700
    • Sydvestjysk Hospital
• Norway
  • Tromsø, Norway, 9038
    • University Hospital of North Norway

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Time Frame
Change from baseline in BODE Index at 6 months	6 months
Change from baseline in BODE Index at 1 year	1 year
Change from baseline in BODE Index at 2 years	2 years

Collaborators and Investigators

• Sponsor: University Hospital of North Norway
• Collaborators: University of Tromso; The Research Council of Norway; The Alfred; Aalborg University; The Royal Norwegian Ministry of Health; Hospital of South West Jutland; LHL Helse; La Trobe University; Esbjerg Municipality
• Investigators: Principal Investigator: Paolo Zanaboni, PhD, University Hospital of North Norway; Principal Investigator: Anne E Holland, PhD, La Trobe University

Publications and helpful links

General Publications

• Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.
• Hoaas H, Zanaboni P, Hjalmarsen A, Morseth B, Dinesen B, Burge AT, Cox NS, Holland AE. Seasonal variations in objectively assessed physical activity among people with COPD in two Nordic countries and Australia: a cross-sectional study. Int J Chron Obstruct Pulmon Dis. 2019 Jun 5;14:1219-1228. doi: 10.2147/COPD.S194622. eCollection 2019.
• Zanaboni P, Dinesen B, Hjalmarsen A, Hoaas H, Holland AE, Oliveira CC, Wootton R. Long-term integrated telerehabilitation of COPD Patients: a multicentre randomised controlled trial (iTrain). BMC Pulm Med. 2016 Aug 22;16(1):126. doi: 10.1186/s12890-016-0288-z.

Helpful Links

• Study website

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: October 2, 2014
• First Submitted That Met QC Criteria: October 6, 2014
• First Posted (Estimate): October 7, 2014

Study Record Updates

• Last Update Posted (Actual): April 30, 2019
• Last Update Submitted That Met QC Criteria: April 26, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Rehabilitation; Telemedicine; Exercise; Costs and Cost Analysis; Treatment Outcome; Physical Therapists; Adaptation, Psychological
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 228919/DHE; HST1117-13 (Other Grant/Funding Number: Northern Norway Regional Health Authority); HST1118-13 (Other Grant/Funding Number: Northern Norway Regional Health Authority)