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Completed

NCT Number: NCT01489241

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

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pulmonary Department - Regional University Hospital of Larisa

Larissa, Thessaly, 41110, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemonitoring

Procedure

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 outcomes

  1. Number of hospital readmissions

    Time frame: 3 months period

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

Secondary outcomes

  1. 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.

    Health related quality of life of the patients as measured by the SF-36 version 2 questionnaire

  2. Hospital anxiety and depression scale HADS

    Time frame: 3 months - at the entry point of the intervention and the end.

    Hospital anxiety and depression scale HADS

  3. 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.

    Health status, measured with the St. George's Respiratory Questionnaire SGRQ

  4. Lung condition as measured by FEV1

    Time frame: 1 month after the hospital discharge.

    Lung condition as measured by FEV1

  5. Mortality

    Time frame: 3 months period

    Mortality

  6. Patients' Acceptance-Satisfaction measured by the WSD Questionnaire

    Time frame: at the 3rd month of the tele-monitoring

    Patients' Acceptance-Satisfaction of telemonitoring measured by the Whole System Demonstrators Questionnaire , for the intervention arm (telemonitoring)

Sponsors and collaborators

Lead sponsor

Regional Health Authority of Sterea & Thessaly

Other Gov

Collaborators

  • Alexander Technological Educational Institute, Thessaloniki, Greece
  • Cities Net SA
  • 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
  • e-Trikala S.A.

Registry information

Official study title

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

Acronym: RHCluster4GR

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Dec 9, 2011
Registry last updated
Feb 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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