Tele Health Monitoring Service for Patients With Chronic Obstructive Pulmonary Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease, COPD
• Intervention / Treatment: Device: Tele Monitoring, using Tunstall monitoring device

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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Mid Region
    • Silkeborg, Mid Region, Denmark, 8600
      • Region Hospital of Silkeborg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; Best practice
EXPERIMENTAL: Intervention; Best practice + Tele Monitoring of physiological parameters (heart frequence, oxygen saturation, weight, FEV1), and answers to disease specific questions, using Tunstall monitoring device.	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.; Other Names: Tunstall monitoring device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of hospitalization days	During twelve months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Frank D Andersen, MD, Diagnostic Center, Regional Hospital of Silkeborg

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ACTUAL): June 6, 2018
• Study Completion (ACTUAL): June 6, 2018

Study Registration Dates

• First Submitted: November 18, 2015
• First Submitted That Met QC Criteria: November 23, 2015
• First Posted (ESTIMATE): November 26, 2015

Study Record Updates

• Last Update Posted (ACTUAL): October 2, 2019
• Last Update Submitted That Met QC Criteria: September 30, 2019
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: UAarhusFA