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

NCT01512992 | Unknown DMC

• 2 other identifiers: RH_pilotCATEC Grant Agreement 250487
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Number of hospital readmissions

  3 months period

Secondary Outcomes (9)

• Health related quality of life of the patients as measured by the SF-36 v2 questionnaire

  3 months - at baseline and study end

• Hospital anxiety and depression scale HADS

  3 months - at baseline and study end

• Lung condition as measured by FEV1

  3 months - at baseline and study end

• Condition-related health status measured by COPD Assessment Test (CAT)

  3 months - at baseline and study end

• Mortality

  3 months period

Study Arms (2)

Home telehealth

EXPERIMENTAL

Procedure: Home telehealth

Usual care

NO INTERVENTION

Interventions

Home telehealth 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.

Home telehealth

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Participation in a previous COPD home telehealth study

Sponsors & Collaborators

• Catalan Agency for Health Information, Assessment and Quality: lead
• Fundació TicSalut: collaborator
• Hospital Clinic of Barcelona: collaborator
• Hospital de Mataró: collaborator

Study Sites (8)

Hospital Germans Trias i Pujol

Badalona, Catalonia, Spain

Location

Capio Hospital Universitari Sagrat Cor

Barcelona, Catalonia, Spain

Location

Hospital Clinic de Barcelona

Barcelona, Catalonia, Spain

Location

Hospital del Mar

Barcelona, Catalonia, Spain

Location

Hospital Plató

Barcelona, Catalonia, Spain

Location

Hospital de Mataró

Mataró, Catalonia, Spain

Location

Hospital Parc Taulí

Sabadell, Catalonia, Spain

Location

Consorci Sanitari de Terrassa

Terrassa, Catalonia, Spain

Location

Related Publications (3)

• 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.

  PMID: 16611656 BACKGROUND

• 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.

  PMID: 16620167 BACKGROUND

• 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.

  PMID: 20197355 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Josep Roca Torrent, MD

  Pulmonary Department - Hospital Clinic of Barcelona

  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 GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2012
• First Posted: January 20, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 5, 2013

Record last verified: 2013-09

Locations

ES (8)