Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Pulmonary Disease, Chronic Obstructive, Telemedicine
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.
Interventions
PROCEDURETelemonitoring
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.
Sponsors
Ministry for Health and Social Solidarity, Greece
Municipality of Trikala, Greece
e-Trikala S.A.
Cities Net SA
Institute of Biomedical Research & Technology, Larissa, Greece
Institute of Communications and Computer Systems, Athens, Greece
Alexander Technological Educational Institute, Thessaloniki, Greece
University of Macedonia, Thessaloniki, Greece
University of Thessaly
Regional Health Authority of Sterea & Thessaly
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of hospital readmissions | 3 months period | Number of hospital readmissions after the hospital discharged of the patient after a COPD exacerbation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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) |
| Lung condition as measured by FEV1 | 1 month after the hospital discharge. | Lung condition as measured by FEV1 |
Countries
Greece
Outcome results
None listed