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

NCT02258646 | Completed

• 3 other identifiers: 228919/DHEHST1117-13HST1118-13
• Study Type: interventional
• Target: 120
• Locations: 3 countries
• Sites: 3

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Exercise; Rehabilitation; Telemedicine; Treatment Outcome; Costs and Cost Analysis; Physical Therapists; Adaptation, Psychological

Outcome Measures

Primary Outcomes (1)

• Combined number of hospitalizations and emergency department presentations

  Two years

Secondary Outcomes (27)

• Hospitalizations

  Two years

• Emergency department presentations

  Two years

• Mortality

  Two years

• Time free from first hospitalization or emergency department presentation

  Two years

• Cost-effectiveness

  Two years

Other Outcomes (3)

• 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

Study Arms (3)

Telerehabilitation

EXPERIMENTAL

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

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

Unsupervised exercise training at home

EXPERIMENTAL

Unsupervised exercise training at home

Behavioral: Exercise training at home

Usual care

NO INTERVENTION

Usual care

Interventions

Exercise training at home BEHAVIORAL

Telerehabilitation; Unsupervised exercise training at home

Telemonitoring and education/self-management BEHAVIORAL

Telerehabilitation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital of North Norway: lead
• The Research Council of Norway: collaborator
• The Royal Norwegian Ministry of Health: collaborator
• LHL Helse: collaborator
• University of Tromso: collaborator
• La Trobe University: collaborator
• The Alfred: collaborator
• Aalborg University: collaborator
• Esbjerg Hospital - University Hospital of Southern Denmark: collaborator
• Esbjerg Municipality: collaborator

Study Sites (3)

The Alfred

Melbourne, Victoria, 3181, Australia

Location

Sydvestjysk Hospital

Esbjerg, 6700, Denmark

Location

University Hospital of North Norway

Tromsø, 9038, Norway

Location

Related Publications (3)

• 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.

  PMID: 33511633 DERIVED

• 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.

  PMID: 31239657 DERIVED

• 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.

  PMID: 27549782 DERIVED

Related Links

• Study website

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Paolo Zanaboni, PhD

  University Hospital of North Norway

  PRINCIPAL INVESTIGATOR

• Anne E Holland, PhD

  La Trobe University

  PRINCIPAL INVESTIGATOR

• Birthe Dinesen, PhD

  Aalborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 7, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 30, 2019

Record last verified: 2019-04

Locations

AU (1); DK (1); NO (1)