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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Telemonitoring
Sponsored by
Regional Health Authority of Sterea & Thessaly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pulmonary Disease, Chronic Obstructive focused on measuring Pulmonary Disease, Chronic Obstructive, Telemedicine

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pulmonary Department - Regional University Hospital of Larisa

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Telemonitoring

Arm Description

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

Outcomes

Primary Outcome Measures

Number of hospital readmissions
Number of hospital readmissions after the hospital discharged of the patient after a COPD exacerbation

Secondary Outcome Measures

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
Hospital anxiety and depression scale HADS
Hospital anxiety and depression scale HADS
Health status, measured with the St. George's Respiratory Questionnaire SGRQ
Health status, measured with the St. George's Respiratory Questionnaire SGRQ
Lung condition as measured by FEV1
Lung condition as measured by FEV1
Mortality
Mortality
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)

Full Information

First Posted
December 6, 2011
Last Updated
February 21, 2015
Sponsor
Regional Health Authority of Sterea & Thessaly
Collaborators
Ministry for Health and Social Solidarity, Greece, Municipality of Trikala, Greece, e-Trikala S.A., Cities Net SA, Institute of Biomedical Research & Technology, Larissa, Greece, Institute of Communications and Computer Systems, Athens, Greece, Alexander Technological Educational Institute, Thessaloniki, Greece, University of Macedonia, Thessaloniki, Greece, University of Thessaly
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1. Study Identification

Unique Protocol Identification Number
NCT01489241
Brief Title
Short-term Telehealth Follow up After Hospital Discharge for Chronic Obstructive Pulmonary Disease Exacerbation
Acronym
RHCluster4GR
Official Title
Renewing Health RCT in Central Greece for the Evaluation of Short-term Telehealth Follow up After Hospital Discharge for COPD Exacerbation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regional Health Authority of Sterea & Thessaly
Collaborators
Ministry for Health and Social Solidarity, Greece, Municipality of Trikala, Greece, e-Trikala S.A., Cities Net SA, Institute of Biomedical Research & Technology, Larissa, Greece, Institute of Communications and Computer Systems, Athens, Greece, Alexander Technological Educational Institute, Thessaloniki, Greece, University of Macedonia, Thessaloniki, Greece, University of Thessaly

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Pulmonary Disease, Chronic Obstructive, Telemedicine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
155 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konstantinos Gourgoulianis, MD, PhD
Organizational Affiliation
Pulmonary Department - University Hospital of Larisa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pulmonary Department - Regional University Hospital of Larisa
City
Larisa
State/Province
Thessaly
ZIP/Postal Code
41110
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
20197355
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.
Results Reference
background
Links:
URL
http://www.renewinghealth.eu/
Description
"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"

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

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