Tele Health Monitoring Service for Patients With Chronic Obstructive Pulmonary Disease

University of Aarhus

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease, COPD

Treatments: Device: Tele Monitoring, using Tunstall monitoring device

Study type: Interventional

Funder types: Other

Identifiers

NCT02615795

UAarhusFA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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
• Asthma
• Inability to use the equipment
• Severe language barriers
• Drug abuse
• Alcohol abuse

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Control

No Intervention group

Description:

Best practice

Intervention

Experimental group

Description:

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

Treatment:

Device: Tele Monitoring, using Tunstall monitoring device