Short-term Telehealth Follow up After Hospital Discharge for Chronic Obstructive Pulmonary Disease Exacerbation

Pulmonary Disease, Chronic Obstructive Clinical Trial

— RHCluster4GR  

Official title:

Renewing Health RCT in Central Greece for the Evaluation of Short-term Telehealth Follow up After Hospital Discharge for COPD Exacerbation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01489241
• Other study ID #: FR2017
• Secondary ID: EC Grant Agreeme
• Status: Completed
• Phase: N/A
• First received: December 6, 2011
• Last updated: February 21, 2015
• Start date: March 2011
• Est. completion date: January 2014

Study information

• Verified date: February 2015
• Source: Regional Health Authority of Sterea & Thessaly
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether the introduction of a short-term telemonitoring program for chronic obstructive pulmonary disease (COPD) patients discharged from the hospital after disease exacerbation produces benefits in terms of a reduction in hospital readmissions and health related quality of life. In addition the trials evaluate the economical and organisational impact of the services and examine their acceptability by patients and health professionals.

Description:

The purpose of this study is to the evaluate the use of a close phone-based tele-monitoring platform will reflected by less hospital re-admissions, will change their generic and disease specific quality of life compared with usual care. Following this; it is also hypothesized that this will also lead to less patients' deaths. In addition the patients' satisfaction using the telemedicine service will be studied. A Cost-Effective Analysis will evaluate the tele-health service compared with the usual care from the health and social perspective.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: January 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Exacerbation of COPD according to the GOLD guidelines

• Age > 40 years

• Capability to use the devices provided

• Willing to participate

Exclusion Criteria:

included in previous COPD monitoring 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:
• Telemonitoring
Within 24 hours after patient's discharge, the telemedicine equipment is installed at the patient's home and patients are trained in the use of the equipment. Patients are followed by a dedicated telehealth centre. Patients at home are asked to fill out each morning the CAT questionnaire and to record extra use of COPD relief medications. Patients in stable conditions perform telespirometry and teleoximetry at 4 and 12 weeks. When a clinical worsening is detected (increase in CAT score by 5 points or higher on two consecutive days) the patient is contacted and asked to perform ad hoc telespirometry and teleoximetry and to send the data to the telehealth centre.

Locations

Country	Name	City	State
Greece	Pulmonary Department - Regional University Hospital of Larisa	Larisa	Thessaly

Sponsors (10)

Lead Sponsor	Collaborator
Regional Health Authority of Sterea & Thessaly	Alexander Technological Educational Institute, Thessaloniki, Greece, Cities Net SA, e-Trikala S.A., Institute of Biomedical Research & Technology, Larissa, Greece, Institute of Communications and Computer Systems, Athens, Greece, Ministry for Health and Social Solidarity, Greece, Municipality of Trikala, Greece, University of Macedonia, Thessaloniki, Greece, University of Thessaly

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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	Number of hospital readmissions after the hospital discharged of the patient after a COPD exacerbation	3 months period	No
Secondary	Health related quality of life of the patients as measured by the SF-36 version 2 questionnaire	Health related quality of life of the patients as measured by the SF-36 version 2 questionnaire	3 months - at the entry point of the intervention and the end.	No
Secondary	Hospital anxiety and depression scale HADS	Hospital anxiety and depression scale HADS	3 months - at the entry point of the intervention and the end.	No
Secondary	Health status, measured with the St. George's Respiratory Questionnaire SGRQ	Health status, measured with the St. George's Respiratory Questionnaire SGRQ	3 months - at the entry point of the intervention and the end.	No
Secondary	Lung condition as measured by FEV1	Lung condition as measured by FEV1	1 month after the hospital discharge.	No
Secondary	Mortality	Mortality	3 months period	No
Secondary	Patients' Acceptance-Satisfaction measured by the WSD Questionnaire	Patients' Acceptance-Satisfaction of telemonitoring measured by the Whole System Demonstrators Questionnaire , for the intervention arm (telemonitoring)	at the 3rd month of the tele-monitoring	No

External Links

•   "The Renewing Health project is partially funded under the ICT Policy Support Programme (ICT PSP) as part of the Competitiveness and Innovation Framework Programme by the European Community"