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

Not Applicable

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Procedure: Telemonitoring

• Registration Number: NCT01489241
• Lead Sponsor: Regional Health Authority of Sterea & Thessaly

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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-12-06
• Study First Submitted QC: 2011-12-07
• Study First Posted: 2011-12-09
• Primary Completion: 2013-11
• Study Completion: 2014-01
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-21
• Last Update Posted: 2015-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemonitoring	Telemonitoring	-

Primary Outcome Measures

Name	Time	Method
Number of hospital readmissions	3 months period	Number of hospital readmissions after the hospital discharged of the patient after a COPD exacerbation

Secondary Outcome Measures

Name	Time	Method
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.	Health related quality of life of the patients as measured by the SF-36 version 2 questionnaire
Hospital anxiety and depression scale HADS	3 months - at the entry point of the intervention and the end.	Hospital anxiety and depression scale HADS
Health status, measured with the St. George's Respiratory Questionnaire SGRQ	3 months - at the entry point of the intervention and the end.	Health status, measured with the St. George's Respiratory Questionnaire SGRQ
Lung condition as measured by FEV1	1 month after the hospital discharge.	Lung condition as measured by FEV1
Mortality	3 months period	Mortality
Patients' Acceptance-Satisfaction measured by the WSD Questionnaire	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)

Trial Locations

Locations (1)

Pulmonary Department - Regional University Hospital of Larisa; 🇬🇷 Larisa, Thessaly, Greece