Tele Health Monitoring Service for Patients With Chronic Obstructive Pulmonary Disease. A Clinical, Randomized, Controlled Study for Evaluation of Clinical and Economic Consequences of Monitoring Service
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Obstructive Pulmonary Disease, COPD
- Sponsor
- University of Aarhus
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Number of hospitalization days
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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
- •Not able to give written or oral consent
- •Terminal disease, such as cancer
- •Unstable heart disease, such as coronary infarction within the last to month
- •Disabling psychiatric disease
- •Inability to use the equipment
- •Severe language barriers
- •Drug abuse
- •Alcohol abuse
Outcomes
Primary Outcomes
Number of hospitalization days
Time Frame: During twelve months
Secondary Outcomes
- Duration of COPD related hospitalizations, in days(Twelve months)
- Sensitivity of physiological measurements in detecting COPD exacerbation(During six months of intervention)
- Number of unplanned contact to primary health sector(Twelve months)
- Health related quality of life(Twelve months)
- Number of hospitalizations caused by COPD exacerbation(During twelve months)
- Number of self-addressed COPD exacerbations(Twelve months)
- Number of COPD related contacts to emergency rooms(Twelve months)
- Number of all cause contacts to primary health sector(Twelve months)
- Mortality(During twelve months)