Clinical trial NCT02615795: Tele Health Monitoring Service for Patients With Chronic Obstructive Pulmonary Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease, COPD
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2015-11-26
Enrollment: 160
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of hospitalization days
timeFrame: During twelve months
Secondary outcomes:
measure: Duration of COPD related hospitalizations, in days
timeFrame: Twelve months
measure: Number of hospitalizations caused by COPD exacerbation
timeFrame: During twelve months
measure: Number of COPD related contacts to emergency rooms
timeFrame: Twelve months
measure: Number of self-addressed COPD exacerbations
timeFrame: Twelve months
measure: Sensitivity of physiological measurements in detecting COPD exacerbation
timeFrame: During six months of intervention
measure: Number of unplanned contact to primary health sector
timeFrame: Twelve months
measure: Health related quality of life
timeFrame: Twelve months
measure: Number of all cause contacts to primary health sector
timeFrame: Twelve months
measure: Mortality
timeFrame: During twelve months
Other outcomes:
Locations:
city: Silkeborg
country: Denmark
facility: Region Hospital of Silkeborg
state: Mid Region
Study officials:
affiliation: Diagnostic Center, Regional Hospital of Silkeborg
name: Frank D Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References: