Tele Health Monitoring Service for Patients With Chronic Obstructive Pulmonary Disease

Not Applicable

Completed

Brief Summary: The aim of this study is to evaluate the effect of monitoring patients with chronic obstructive pulmonary disease (COPD) after a hospitalization for COPD exacerbation or pneumonia. The patients are randomized to receive either standard treatment and follow up, or standard treatment and follow up, plus tele monitoring of key clinical parameters and symptoms for six months.

Detailed Description: Telemedicine is a relatively new approach for the management of chronic obstructive pulmonary disease (COPD) disease. Telemedicine, for monitoring disease exacerbation, is the focus area of our research. The patient monitoring offers the possibility of early initiation of treatment of patients who has evidence of COPD exacerbation or pulmonary infection. The self-monitoring of potential exacerbation is started after a hospitalization, and is done by the patient on a daily (not on weekends) basis initially. After one month the monitoring is made at least three times weekly during the rest of the intervention period of six months. With the help of the monitoring equipment, the patient answers a short series of health related questions, and makes simple measurements of oxygen saturation, heart rate, lung function and weight. Data is sent to the hospital, and here the staff can assess the data and respond to them the same day, with a phone call to the patient, if the patient's condition has changed. The selected telemonitoring-equipment, consists of a monitoring systems for the assessment of key clinical parameters and symptoms. All patients, in the intervention group as well as in the control group, are trained in the use of a standardized self-treatment plan. It is expected that the monitoring of symptoms and signs will support patient empowerment.

The investigation is planned to assess the clinical and economic effects of the intervention.

Recruitment & Eligibility

Inclusion Criteria

Chronic Obstructive Pulmonary Disease COPD with FEV1/FVC (Forced Expiratory Volume in 1 second / Forced Vital Capacity) below 70% at all times during the study. FEV1 below 51% during inclusion and during the further study. Inclusion takes place during a hospitalization, with exacerbation in pulmonary symptoms.

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Intervention	Tele Monitoring, using Tunstall monitoring device	Best practice + Tele Monitoring of physiological parameters (heart frequence, oxygen saturation, weight, FEV1), and answers to disease specific questions, using Tunstall monitoring device.

Primary Outcome Measures

Name	Time	Method
Number of hospitalization days	During twelve months

Secondary Outcome Measures

Name	Time	Method
Duration of COPD related hospitalizations, in days	Twelve months
Sensitivity of physiological measurements in detecting COPD exacerbation	During six months of intervention	Relation between physiological measurements and COPD exacerbation
Number of unplanned contact to primary health sector	Twelve months	Contacts to general practitioner or Doctor on call in the primary health sector
Health related quality of life	Twelve months	Saint George´s respiratory questionnaire, Hospital Anxiety and Depression score, SF-36 questionnaire
Number of hospitalizations caused by COPD exacerbation	During twelve months
Number of self-addressed COPD exacerbations	Twelve months	Without primary contact to medical staff
Number of COPD related contacts to emergency rooms	Twelve months
Number of all cause contacts to primary health sector	Twelve months	Contacts to general practitioner or Doctor on call in the primary health sector
Mortality	During twelve months

Locations (1): Region Hospital of Silkeborg
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Silkeborg, Mid Region, Denmark