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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Procedure: Telemonitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>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 | |
| Experimental: Telemonitoring<br> | Procedure: Telemonitoring<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hospital readmissions | Number of hospital readmissions after the hospital discharged of the patient after a COPD exacerbation | 3 months period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life of the patients as measured by the SF-36 version 2 questionnaire | 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 | 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 | 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 | Lung condition as measured by FEV1 | 1 month after the hospital discharge. | 
| Mortality | Mortality | 3 months period | 
| Patients' Acceptance-Satisfaction measured by the WSD Questionnaire | Patients' Acceptance-Satisfaction of telemonitoring measured by the Whole System Demonstrators Questionnaire , for the intervention arm (telemonitoring) | at the 3rd month of the tele-monitoring | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Disease, Chronic Obstructive, Telemedicine