Telemonitoring of Patients With COPD in Carinthia

Study Overview
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Brief Summary
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Evaluation whether the introduction of large-scale telemonitoring of patients with COPD produces benefits in terms of reduced hospital readmissions, improved health related quality of life and health status. In addition, the trials evaluate the economical and organizational impact of the new services and examine their acceptability by patients and health professionals.

Official Title
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REgions of Europe WorkiNg toGether for HEALTH (Renewing Health)

Conditions
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Pulmonary Disease, Chronic Obstructive (COPD)

Intervention / Treatment
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* Other: self-monitoring for patients with severe COPD
* Other: nurse-monitoring for patients with severe COPD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD 3 or 4 Be able to use the system provided Life expectancy > 12 months Exclusion Criteria:
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Participants in the control group receive usual care. | |
| Experimental: Self monitoring for patients with COPD<br> | Other: self-monitoring for patients with severe COPD<br>* Intervention Group entering vital parameters via Web Portal or automatic call center.<br>|
| Experimental: Nurse monitoring for patients with COPD<br> | Other: nurse-monitoring for patients with severe COPD<br>* Nurses are entering vital parameters of the patient with mobile devices.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Related Quality of Life as Measured by the Short-Form 36 Version 2 Questionnaire; The Short Form (36) Health Survey is a 36-item, Patient-reported Survey of Patient Health. The SF-36 is a Measure of Health Status. | Baseline analyses and analyses after 12 months were conducted. Normal distribution is not given for SF-36 scales, means and Standard Deviation are reported. A high score defines a more favorable health state, items are scored on a 0 to 100 range. Scale scores represent the average for all items in the scale that the respondent answered. | 12 months | 
| Number of Inpatient Stays |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Bed Days for Hospitalised Patients |  | 12 months | 
| Number of Primary Care Visits | Not all data were available, so only participants with consistent data were taken into comparison, this lead to a lower number of patients in this outcome measurement. | 12 months | 
| Number of Specialist Visits |  | 12 months | 
| Number of Consultations of Emergency Doctor |  | 12 months | 
| All Cause Mortality | deceased patients in respect to participating patients, by obituary column | 12 months | 
| COPD Assessment Test CAT (Carinthia) | No data available | 12 months | 
| St. George's Respiratory Questionnaire SGRQ (Carinthia) | The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. Scores are calculated for three domains: Symptoms, Activity and Impacts as well as a total score. Psychometric testing has demonstrated its repeatability, reliability and validity. Sensitivity has been demonstrated in clinical trials. A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing. The SGRQ has been used in a range of disease groups including asthma, chronic obstructive pulmonary disease (COPD) and bronchiectasis, and in a range of settings such as randomised controlled therapy trials and population surveys.Due to missing data not all questoinnaires could be taken into consideration. Normal distribution is not given for SGRQ scales; Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best pos | 12 months | 
| BODE Index (Carinthia) |  | 12 months |