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

Pulmonary Disease, Chronic Obstructive Clinical Trial

— iTrain  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02258646
• Other study ID #: 228919/DHE
• Secondary ID: HST1117-13HST111
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: December 2018

Study information

• Verified date: April 2019
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Exercise training at home

• Telemonitoring and education/self-management

Locations

Country	Name	City	State
Australia	The Alfred	Melbourne	Victoria
Denmark	Sydvestjysk Hospital	Esbjerg
Norway	University Hospital of North Norway	Tromsø

Sponsors (10)

Lead Sponsor	Collaborator
University Hospital of North Norway	Aalborg University, Esbjerg Municipality, La Trobe University, LHL Helse, Sydvestjysk Hospital, The Alfred, The Research Council of Norway, The Royal Norwegian Ministry of Health, University of Tromso

Countries where clinical trial is conducted

Australia,  Denmark,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in BODE Index at 6 months		6 months
Other	Change from baseline in BODE Index at 1 year		1 year
Other	Change from baseline in BODE Index at 2 years		2 years
Primary	Combined number of hospitalizations and emergency department presentations		Two years
Secondary	Hospitalizations		Two years
Secondary	Emergency department presentations		Two years
Secondary	Mortality		Two years
Secondary	Time free from first hospitalization or emergency department presentation		Two years
Secondary	Cost-effectiveness	Cost-Utility Analysis (Cost/QALY)	Two years
Secondary	Change from baseline in COPD Assessment Test at 6 months		6 months
Secondary	Change from baseline in COPD Assessment Test at 1 year		One year
Secondary	Change from baseline in COPD Assessment Test at 2 years		Two years
Secondary	Change from baseline in EQ-5D at 6 months		Six months
Secondary	Change from baseline in EQ-5D at 1 year		One year
Secondary	Change from baseline in EQ-5D at 2 years		Two years
Secondary	Change from baseline in Hospital Anxiety and Depression Scale at 6 months		Six months
Secondary	Change from baseline in Hospital Anxiety and Depression Scale at 1 year		One Year
Secondary	Change from baseline in Hospital Anxiety and Depression Scale at 2 years		Two years
Secondary	Change from baseline in Generalized Self-Efficacy Scale at 6 months		Six months
Secondary	Change from baseline in Generalized Self-Efficacy Scale at 1 year		One year
Secondary	Change from baseline in Generalized Self-Efficacy Scale at 2 years		Two years
Secondary	Change from baseline in 6- minute walking distance at 6 months		Six months
Secondary	Change from baseline in 6- minute walking distance at 1 year		One year
Secondary	Change from baseline in 6- minute walking distance at 2 years		Two years
Secondary	Change from baseline in physical activity at 6 months		Six months
Secondary	Change from baseline in physical activity at 1 year		One year
Secondary	Change from baseline in physical activity at 2 years		Two years
Secondary	Patient Global Impression of Change after 2 years		Two years
Secondary	Hospitalizations at 1 year		One year
Secondary	Emergency department presentations at 1 year		One year
Secondary	Mortality at 1 year		One year

External Links

•   Study website