Home Telehealth Follow-up After Hospital Discharge for Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT ID: NCT01512992

Last Updated: 2013-09-05

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-12-31

Brief Summary

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The purpose of this study is to assess the effects of a complex telemedicine intervention as a part of an integrated care program for patients with chronic obstructive pulmonary disease (COPD) discharged from the hospital after disease exacerbation. Will be evaluated whether the intervention produces benefits in terms of mortality, reduction in hospital readmissions and health-related quality of life. In addition, the trial evaluates the economical and organizational impact of the new service and examines its acceptability by patients and health professionals.

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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Home telehealth

Group Type EXPERIMENTAL

Home telehealth

Intervention Type PROCEDURE

Patients receive tailored intervention according to their clinical complexity.

All patients in the intervention group receive:

* Personalised care plan
* Education on self-management
* Access to a personalized online health folder
* Access to Call center
* Access to primary care and hospital specialists; follow-up visits for evaluation of clinical recovery and care plan adjustments (if needed).

Patients with LOW complexity additionally receive:

* Daily videoconferences for the 1st week after discharge
* Remote monitoring for respiratory parameters. Sensors are selected on an individual basis by the medical specialists.

Patients with HIGH complexity additionally receive:

* Videoconferences for at least 1 month after discharge, scheduled on an individual basis.
* Remote monitoring for respiratory parameters.
* One monthly phone call from the call centre to promote and assess patient self-management.

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Home telehealth

Patients receive tailored intervention according to their clinical complexity.

All patients in the intervention group receive:

* Personalised care plan
* Education on self-management
* Access to a personalized online health folder
* Access to Call center
* Access to primary care and hospital specialists; follow-up visits for evaluation of clinical recovery and care plan adjustments (if needed).

Patients with LOW complexity additionally receive:

* Daily videoconferences for the 1st week after discharge
* Remote monitoring for respiratory parameters. Sensors are selected on an individual basis by the medical specialists.

Patients with HIGH complexity additionally receive:

* Videoconferences for at least 1 month after discharge, scheduled on an individual basis.
* Remote monitoring for respiratory parameters.
* One monthly phone call from the call centre to promote and assess patient self-management.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Exacerbation of COPD
* Age \> 40 years
* Capability to use the devices provided
* Willing to participate

Exclusion Criteria

• Participation in a previous COPD home telehealth study
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundació TicSalut

OTHER

Sponsor Role collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role collaborator

Hospital de Mataró

OTHER

Sponsor Role collaborator

Catalan Agency for Health Information, Assessment and Quality

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Josep Roca Torrent, MD

Role: PRINCIPAL_INVESTIGATOR

Pulmonary Department - Hospital Clinic of Barcelona

Locations

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Hospital Germans Trias i Pujol

Badalona, Catalonia, Spain

Site Status

Capio Hospital Universitari Sagrat Cor

Barcelona, Catalonia, Spain

Site Status

Hospital Clinic de Barcelona

Barcelona, Catalonia, Spain

Site Status

Hospital del Mar

Barcelona, Catalonia, Spain

Site Status

Hospital Plató

Barcelona, Catalonia, Spain

Site Status

Hospital de Mataró

Mataró, Catalonia, Spain

Site Status

Hospital Parc Taulí

Sabadell, Catalonia, Spain

Site Status

Consorci Sanitari de Terrassa

Terrassa, Catalonia, Spain

Site Status

Countries

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Spain

References

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Casas A, Troosters T, Garcia-Aymerich J, Roca J, Hernandez C, Alonso A, del Pozo F, de Toledo P, Anto JM, Rodriguez-Roisin R, Decramer M; members of the CHRONIC Project. Integrated care prevents hospitalisations for exacerbations in COPD patients. Eur Respir J. 2006 Jul;28(1):123-30. doi: 10.1183/09031936.06.00063205. Epub 2006 Apr 12.

Reference Type BACKGROUND
PMID: 16611656 (View on PubMed)

Finkelstein SM, Speedie SM, Potthoff S. Home telehealth improves clinical outcomes at lower cost for home healthcare. Telemed J E Health. 2006 Apr;12(2):128-36. doi: 10.1089/tmj.2006.12.128.

Reference Type BACKGROUND
PMID: 16620167 (View on PubMed)

Polisena J, Tran K, Cimon K, Hutton B, McGill S, Palmer K, Scott RE. Home telehealth for chronic obstructive pulmonary disease: a systematic review and meta-analysis. J Telemed Telecare. 2010;16(3):120-7. doi: 10.1258/jtt.2009.090812. Epub 2010 Mar 2.

Reference Type BACKGROUND
PMID: 20197355 (View on PubMed)

Other Identifiers

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EC Grant Agreement 250487

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

RH_pilotCAT

Identifier Type: -

Identifier Source: org_study_id