Clinical trial NCT01489241: Short-term Telehealth Follow up After Hospital Discharge for Chronic Obstructive Pulmonary Disease Exacerbation
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
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Pulmonary Disease, Chronic Obstructive
Telemedicine
Lead sponsor: Regional Health Authority of Sterea & Thessaly
Sponsor class: OTHER_GOV
Collaborators: name: Ministry for Health and Social Solidarity, Greece
name: Municipality of Trikala, Greece
name: e-Trikala S.A.
name: Cities Net SA
name: Institute of Biomedical Research & Technology, Larissa, Greece
name: Institute of Communications and Computer Systems, Athens, Greece
name: Alexander Technological Educational Institute, Thessaloniki, Greece
name: University of Macedonia, Thessaloniki, Greece
name: University of Thessaly
First posted: 2011-12-09
Enrollment: 155
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Number of hospital readmissions
timeFrame: 3 months period
Secondary outcomes:
measure: Health related quality of life of the patients as measured by the SF-36 version 2 questionnaire
timeFrame: 3 months - at the entry point of the intervention and the end.
measure: Hospital anxiety and depression scale HADS
timeFrame: 3 months - at the entry point of the intervention and the end.
measure: Health status, measured with the St. George's Respiratory Questionnaire SGRQ
timeFrame: 3 months - at the entry point of the intervention and the end.
measure: Lung condition as measured by FEV1
timeFrame: 1 month after the hospital discharge.
measure: Mortality
timeFrame: 3 months period
measure: Patients' Acceptance-Satisfaction measured by the WSD Questionnaire
timeFrame: at the 3rd month of the tele-monitoring
Other outcomes:
Locations:
city: Larisa
country: Greece
facility: Pulmonary Department - Regional University Hospital of Larisa
state: Thessaly
Study officials:
affiliation: Pulmonary Department - University Hospital of Larisa
name: Konstantinos Gourgoulianis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.