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

NCT01489241 | Completed DMC

• 2 other identifiers: FR2017EC Grant Agreement 250487
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Pulmonary Disease, Chronic Obstructive; Telemedicine

Outcome Measures

Primary Outcomes (1)

• Number of hospital readmissions

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

  3 months period

Secondary Outcomes (6)

• 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

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

• 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

  1 month after the hospital discharge.

• Mortality

  3 months period

Study Arms (2)

Usual care

NO INTERVENTION

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

Telemonitoring

EXPERIMENTAL

Procedure: Telemonitoring

Interventions

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.

Telemonitoring

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Exacerbation of COPD according to the GOLD guidelines
• Age \> 40 years
• Capability to use the devices provided
• Willing to participate

You may not qualify if:

• included in previous COPD monitoring study

Sponsors & Collaborators

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

Study Sites (1)

Pulmonary Department - Regional University Hospital of Larisa

Larissa, Thessaly, 41110, Greece

Location

Related 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.

  PMID: 20197355 BACKGROUND

Related 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"

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Konstantinos Gourgoulianis, MD, PhD

  Pulmonary Department - University Hospital of Larisa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of the Pulmonary Department, University Hospital of Larisa

Study Record Dates

• First Submitted: December 6, 2011
• First Posted: December 9, 2011
• Study Start: March 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: January 1, 2014
• Last Updated: February 24, 2015

Record last verified: 2015-02

Locations

GR (1)