Short-term Telehealth Follow up After Hospital Discharge for Chronic Obstructive Pulmonary Disease Exacerbation (RHCluster4GR)

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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Procedure: Telemonitoring

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 155
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Thessaly
    • Larisa, Thessaly, Greece, 41110
      • Pulmonary Department - Regional University Hospital of Larisa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telemonitoring	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.
No Intervention: Usual care; Patients in the control group receive usual care and visit the outpatient department at 4 and at 12 weeks after discharge when pulse rate, oxygen saturation and spirometry is performed. In the case of clinical deterioration during the study, the patients contact as usual their general practitioner. Usual care of COPD patients consists of regular visits to the specialist or primary care clinics every time a medication change is made or a medical examination is needed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of hospital readmissions	Number of hospital readmissions after the hospital discharged of the patient after a COPD exacerbation	3 months period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Hospital anxiety and depression scale HADS	Hospital anxiety and depression scale HADS	3 months - at the entry point of the intervention and the end.
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.
Lung condition as measured by FEV1	Lung condition as measured by FEV1	1 month after the hospital discharge.
Mortality	Mortality	3 months period
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

Collaborators and Investigators

• Sponsor: Regional Health Authority of Sterea & Thessaly
• Collaborators: University of Thessaly; Alexander Technological Educational Institute, Thessaloniki, Greece; Institute of Communications and Computer Systems, Athens, Greece; Ministry for Health and Social Solidarity, Greece; Municipality of Trikala, Greece; Institute of Biomedical Research & Technology, Larissa, Greece; University of Macedonia, Thessaloniki, Greece; e-Trikala S.A.; Cities Net SA
• Investigators: Principal Investigator: Konstantinos Gourgoulianis, MD, PhD, Pulmonary Department - University Hospital of Larisa

Publications and helpful links

General Publications

• 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.

Helpful 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"

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: December 6, 2011
• First Submitted That Met QC Criteria: December 7, 2011
• First Posted (Estimate): December 9, 2011

Study Record Updates

• Last Update Posted (Estimate): February 24, 2015
• Last Update Submitted That Met QC Criteria: February 21, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Telemedicine; Pulmonary Disease, Chronic Obstructive
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Chronic Disease
• Other Study ID Numbers: FR2017; EC Grant Agreement 250487 (Other Grant/Funding Number: European Commission CIP/PSP-ICT Grant Agreement 250487)