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

Not Applicable

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Procedure: Home telehealth

• Registration Number: NCT01512992
• Lead Sponsor: Catalan Agency for Health Information, Assessment and Quality

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-16
• Study First Submitted QC: 2012-01-19
• Study First Posted: 2012-01-20
• Study Start: 2012-04
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-04
• Last Update Posted: 2013-09-05
• Primary Completion: 2013-10
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 380

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home telehealth	Home telehealth	-

Primary Outcome Measures

Name	Time	Method
Number of hospital readmissions	3 months period

Secondary Outcome Measures

Name	Time	Method
Number of emergency room visits	at the 3rd month (end of trial)
Length of stay in days for each readmission	3 months period
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
Patients' Acceptance-Satisfaction measured by the WSD Questionnaire	at the 3rd month of the telehealth intervention
Time in days to first readmission	3 months period

Trial Locations

Locations (8)

Hospital del Mar; 🇪🇸 Barcelona, Catalonia, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Catalonia, Spain

Capio Hospital Universitari Sagrat Cor; 🇪🇸 Barcelona, Catalonia, Spain

Hospital Plató; 🇪🇸 Barcelona, Catalonia, Spain

Hospital de Mataró; 🇪🇸 Mataró, Catalonia, Spain

Hospital Parc Taulí; 🇪🇸 Sabadell, Catalonia, Spain

Consorci Sanitari de Terrassa; 🇪🇸 Terrassa, Catalonia, Spain

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Catalonia, Spain