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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Renewing Health RCT in Catalonia for the Evaluation of Home Telehealth Follow-up After Hospital Discharge for COPD Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01512992
• Other study ID #: RH_pilotCAT
• Secondary ID: EC Grant Agreeme
• Status: Active, not recruiting
• Phase: N/A
• First received: January 16, 2012
• Last updated: September 4, 2013
• Start date: April 2012
• Est. completion date: December 2013

Study information

• Verified date: September 2013
• Source: Catalan Agency for Health Information, Assessment and Quality
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 380
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Germans Trias i Pujol	Badalona	Catalonia
Spain	Capio Hospital Universitari Sagrat Cor	Barcelona	Catalonia
Spain	Hospital Clinic de Barcelona	Barcelona	Catalonia
Spain	Hospital del Mar	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

Sponsors (4)

Lead Sponsor	Collaborator
Catalan Agency for Health Information, Assessment and Quality	Fundació TicSalut, Hospital Clinic of Barcelona, Hospital de Mataró

Country where clinical trial is conducted

Spain, 

References & Publications (3)

Casas A, Troosters T, Garcia-Aymerich J, Roca J, Hernández C, Alonso A, del Pozo F, de Toledo P, Antó JM, Rodríguez-Roisín 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. Epub 2006 Apr 12. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of hospital readmissions		3 months period	No
Secondary	Health related quality of life of the patients as measured by the SF-36 v2 questionnaire		3 months - at baseline and study end	No
Secondary	Hospital anxiety and depression scale HADS		3 months - at baseline and study end	No
Secondary	Lung condition as measured by FEV1		3 months - at baseline and study end	No
Secondary	Condition-related health status measured by COPD Assessment Test (CAT)		3 months - at baseline and study end	No
Secondary	Mortality		3 months period	No
Secondary	Patients' Acceptance-Satisfaction measured by the WSD Questionnaire		at the 3rd month of the telehealth intervention	No
Secondary	Time in days to first readmission		3 months period	No
Secondary	Length of stay in days for each readmission		3 months period	No
Secondary	Number of emergency room visits		at the 3rd month (end of trial)	No