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

NCT ID: NCT02258646

Last Updated: 2019-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Telerehabilitation

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

Group Type EXPERIMENTAL

Exercise training at home

Intervention Type BEHAVIORAL

Telemonitoring and education/self-management

Intervention Type BEHAVIORAL

Unsupervised exercise training at home

Unsupervised exercise training at home

Group Type EXPERIMENTAL

Exercise training at home

Intervention Type BEHAVIORAL

Usual care

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise training at home

Intervention Type BEHAVIORAL

Telemonitoring and education/self-management

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Research Council of Norway

OTHER

Sponsor Role collaborator

The Royal Norwegian Ministry of Health

OTHER

Sponsor Role collaborator

LHL Helse

OTHER

Sponsor Role collaborator

University of Tromso

OTHER

Sponsor Role collaborator

La Trobe University

OTHER

Sponsor Role collaborator

The Alfred

OTHER

Sponsor Role collaborator

Aalborg University

OTHER

Sponsor Role collaborator

Esbjerg Hospital - University Hospital of Southern Denmark

OTHER

Sponsor Role collaborator

Esbjerg Municipality

OTHER_GOV

Sponsor Role collaborator

University Hospital of North Norway

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paolo Zanaboni, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of North Norway

Anne E Holland, PhD

Role: PRINCIPAL_INVESTIGATOR

La Trobe University

Birthe Dinesen, PhD

Role: PRINCIPAL_INVESTIGATOR

Aalborg University

Locations

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The Alfred

Melbourne, Victoria, Australia

Site Status

Sydvestjysk Hospital

Esbjerg, , Denmark

Site Status

University Hospital of North Norway

Tromsø, , Norway

Site Status

Countries

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Australia Denmark Norway

References

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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.

Reference Type DERIVED
PMID: 33511633 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31239657 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27549782 (View on PubMed)

Related Links

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Other Identifiers

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HST1117-13

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HST1118-13

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

228919/DHE

Identifier Type: -

Identifier Source: org_study_id

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