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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Ministry for Health and Social Solidarity, Greece
Municipality of Trikala, Greece
Biomedical Research & Technology (BIOMED, Larissa, Greece
Institute of Communications and Computer Systems, Athens, Greece
Alexander Technological Educational Institute, Thessaloniki, Greece
University of Macedonia, Thessaloniki, Greece
University of Thessaly
Information provided by (Responsible Party):
Konstantinos Gourgoulianis, Regional Health Authority of Sterea & Thessaly
ClinicalTrials.gov Identifier:
NCT01489241
First received: December 6, 2011
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Pulmonary Disease, Chronic Obstructive
Procedure: Telemonitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Renewing Health RCT in Central Greece for the Evaluation of Short-term Telehealth Follow up After Hospital Discharge for COPD Exacerbation

Resource links provided by NLM:


Further study details as provided by Regional Health Authority of Sterea & Thessaly:

Primary Outcome Measures:
  • Number of hospital readmissions [ Time Frame: 3 months period ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 months - at the entry point of the intervention and the end. ] [ Designated as safety issue: No ]
    Health related quality of life of the patients as measured by the SF-36 version 2 questionnaire

  • Hospital anxiety and depression scale HADS [ Time Frame: 3 months - at the entry point of the intervention and the end. ] [ Designated as safety issue: No ]
    Hospital anxiety and depression scale HADS

  • 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. ] [ Designated as safety issue: No ]
    Health status, measured with the St. George's Respiratory Questionnaire SGRQ

  • Lung condition as measured by FEV1 [ Time Frame: 1 month after the hospital discharge. ] [ Designated as safety issue: No ]
    Lung condition as measured by FEV1

  • Mortality [ Time Frame: 3 months period ] [ Designated as safety issue: No ]
    Mortality

  • Patients' Acceptance-Satisfaction measured by the WSD Questionnaire [ Time Frame: at the 3rd month of the tele-monitoring ] [ Designated as safety issue: No ]
    Patients' Acceptance-Satisfaction of telemonitoring measured by the Whole System Demonstrators Questionnaire , for the intervention arm (telemonitoring)


Estimated Enrollment: 180
Study Start Date: March 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01489241

Locations
Greece
Pulmonary Department - Regional University Hospital of Larisa
Larisa, Thessaly, Greece, 41110
Sponsors and Collaborators
Regional Health Authority of Sterea & Thessaly
Ministry for Health and Social Solidarity, Greece
Municipality of Trikala, Greece
Biomedical Research & Technology (BIOMED, Larissa, Greece
Institute of Communications and Computer Systems, Athens, Greece
Alexander Technological Educational Institute, Thessaloniki, Greece
University of Macedonia, Thessaloniki, Greece
University of Thessaly
Investigators
Principal Investigator: Konstantinos Gourgoulianis, MD, PhD Pulmonary Department - University Hospital of Larisa
  More Information

Additional Information:
Publications:
Responsible Party: Konstantinos Gourgoulianis, Professor, Director of the Pulmonary Department, University Hospital of Larisa, Regional Health Authority of Sterea & Thessaly
ClinicalTrials.gov Identifier: NCT01489241     History of Changes
Other Study ID Numbers: FR2017, EC Grant Agreement 250487
Study First Received: December 6, 2011
Last Updated: August 26, 2013
Health Authority: Greece: National Organization of Medicines

Keywords provided by Regional Health Authority of Sterea & Thessaly:
Pulmonary Disease, Chronic Obstructive
Telemedicine

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 30, 2014