Clinical trial NCT01512992: Home Telehealth Follow-up After Hospital Discharge for Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: Renewing Health RCT in Catalonia for the Evaluation of Home Telehealth Follow-up After Hospital Discharge for COPD Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Catalan Agency for Health Information, Assessment and Quality
Sponsor class: OTHER_GOV
Collaborators: name: Fundació TicSalut
name: Hospital Clinic of Barcelona
name: Hospital de Mataró
First posted: 2012-01-20
Enrollment: 380
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of hospital readmissions
timeFrame: 3 months period
Secondary outcomes:
measure: Health related quality of life of the patients as measured by the SF-36 v2 questionnaire
timeFrame: 3 months - at baseline and study end
measure: Hospital anxiety and depression scale HADS
timeFrame: 3 months - at baseline and study end
measure: Lung condition as measured by FEV1
timeFrame: 3 months - at baseline and study end
measure: Condition-related health status measured by COPD Assessment Test (CAT)
timeFrame: 3 months - at baseline and study end
measure: Mortality
timeFrame: 3 months period
measure: Patients' Acceptance-Satisfaction measured by the WSD Questionnaire
timeFrame: at the 3rd month of the telehealth intervention
measure: Time in days to first readmission
timeFrame: 3 months period
measure: Length of stay in days for each readmission
timeFrame: 3 months period
measure: Number of emergency room visits
timeFrame: at the 3rd month (end of trial)
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Catalonia
city: Barcelona
country: Spain
facility: Capio Hospital Universitari Sagrat Cor
state: Catalonia
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
state: Catalonia
city: Barcelona
country: Spain
facility: Hospital del Mar
state: Catalonia
city: Barcelona
country: Spain
facility: Hospital Plató
state: Catalonia
city: Mataró
country: Spain
facility: Hospital de Mataró
state: Catalonia
city: Sabadell
country: Spain
facility: Hospital Parc Taulí
state: Catalonia
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Catalonia
Study officials:
affiliation: Pulmonary Department - Hospital Clinic of Barcelona
name: Josep Roca Torrent, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.