Tele Health Monitoring Service for Patients With Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease, COPD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02615795
• Other study ID #: UAarhusFA
• Status: Completed
• Phase: N/A
• Start date: March 2011
• Est. completion date: June 6, 2018

Study information

• Verified date: October 2010
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: June 6, 2018
• Est. primary completion date: June 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

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:

• 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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease, COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Tele Monitoring, using Tunstall monitoring device
Monitoring of symptoms and physiological parameters at home, using Tunstall Healthcare telemedicine equipment. Patients perform physiological measurement. In addition, they correspond to a standardized questionnaire regarding disease specific symptoms. Data is assessed by the medical staff the same day. If the data indicates worsening in the patient's condition, the patient is contacted by phone. The assessment of the patient is made either on the specialist nurse level, or at a conference between the specialist nurse and a senior pulmonary doctor. There is no call center service.

Locations

Country	Name	City	State
Denmark	Region Hospital of Silkeborg	Silkeborg	Mid Region

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

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