Clinical trial NCT02258646: Long-Term Integrated Telerehabilitation of COPD Patients. A Multi-Center Trial
Official title: Long-Term Integrated Telerehabilitation of COPD Patients. A Multi-Center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Exercise
Rehabilitation
Telemedicine
Treatment Outcome
Costs and Cost Analysis
Physical Therapists
Adaptation, Psychological
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: The Royal Norwegian Ministry of Health
name: LHL Helse
name: University of Tromso
name: La Trobe University
name: The Alfred
name: Aalborg University
name: Esbjerg Hospital - University Hospital of Southern Denmark
name: Esbjerg Municipality
First posted: 2014-10-07
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Combined number of hospitalizations and emergency department presentations
timeFrame: Two years
Secondary outcomes:
measure: Hospitalizations
timeFrame: Two years
measure: Emergency department presentations
timeFrame: Two years
measure: Mortality
timeFrame: Two years
measure: Time free from first hospitalization or emergency department presentation
timeFrame: Two years
measure: Cost-effectiveness
timeFrame: Two years
measure: Change from baseline in COPD Assessment Test at 6 months
timeFrame: 6 months
measure: Change from baseline in COPD Assessment Test at 1 year
timeFrame: One year
measure: Change from baseline in COPD Assessment Test at 2 years
timeFrame: Two years
measure: Change from baseline in EQ-5D at 6 months
timeFrame: Six months
measure: Change from baseline in EQ-5D at 1 year
timeFrame: One year
measure: Change from baseline in EQ-5D at 2 years
timeFrame: Two years
measure: Change from baseline in Hospital Anxiety and Depression Scale at 6 months
timeFrame: Six months
measure: Change from baseline in Hospital Anxiety and Depression Scale at 1 year
timeFrame: One Year
measure: Change from baseline in Hospital Anxiety and Depression Scale at 2 years
timeFrame: Two years
measure: Change from baseline in Generalized Self-Efficacy Scale at 6 months
timeFrame: Six months
measure: Change from baseline in Generalized Self-Efficacy Scale at 1 year
timeFrame: One year
measure: Change from baseline in Generalized Self-Efficacy Scale at 2 years
timeFrame: Two years
measure: Change from baseline in 6- minute walking distance at 6 months
timeFrame: Six months
measure: Change from baseline in 6- minute walking distance at 1 year
timeFrame: One year
measure: Change from baseline in 6- minute walking distance at 2 years
timeFrame: Two years
measure: Change from baseline in physical activity at 6 months
timeFrame: Six months
measure: Change from baseline in physical activity at 1 year
timeFrame: One year
measure: Change from baseline in physical activity at 2 years
timeFrame: Two years
measure: Patient Global Impression of Change after 2 years
timeFrame: Two years
measure: Hospitalizations at 1 year
timeFrame: One year
measure: Emergency department presentations at 1 year
timeFrame: One year
measure: Mortality at 1 year
timeFrame: One year
Other outcomes:
measure: Change from baseline in BODE Index at 6 months
timeFrame: 6 months
measure: Change from baseline in BODE Index at 1 year
timeFrame: 1 year
measure: Change from baseline in BODE Index at 2 years
timeFrame: 2 years
Locations:
city: Melbourne
country: Australia
facility: The Alfred
state: Victoria
city: Esbjerg
country: Denmark
facility: Sydvestjysk Hospital
city: Tromsø
country: Norway
facility: University Hospital of North Norway
Study officials:
affiliation: University Hospital of North Norway
name: Paolo Zanaboni, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: La Trobe University
name: Anne E Holland, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aalborg University
name: Birthe Dinesen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.