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Tele Health Monitoring Service for Patients With Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease, COPD

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Tele Monitoring, using Tunstall monitoring device
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Obstructive Pulmonary Disease, COPD

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Region Hospital of Silkeborg

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

Best practice

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

Outcomes

Primary Outcome Measures

Number of hospitalization days

Secondary Outcome Measures

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

Full Information

First Posted
November 18, 2015
Last Updated
September 30, 2019
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT02615795
Brief Title
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

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 6, 2018 (Actual)
Study Completion Date
June 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, COPD

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Best practice
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Best practice + Tele Monitoring of physiological parameters (heart frequence, oxygen saturation, weight, FEV1), and answers to disease specific questions, using Tunstall monitoring device.
Intervention Type
Device
Intervention Name(s)
Tele Monitoring, using Tunstall monitoring device
Other Intervention Name(s)
Tunstall monitoring device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of hospitalization days
Time Frame
During twelve months
Secondary Outcome Measure Information:
Title
Duration of COPD related hospitalizations, in days
Time Frame
Twelve months
Title
Number of hospitalizations caused by COPD exacerbation
Time Frame
During twelve months
Title
Number of COPD related contacts to emergency rooms
Time Frame
Twelve months
Title
Number of self-addressed COPD exacerbations
Description
Without primary contact to medical staff
Time Frame
Twelve months
Title
Sensitivity of physiological measurements in detecting COPD exacerbation
Description
Relation between physiological measurements and COPD exacerbation
Time Frame
During six months of intervention
Title
Number of unplanned contact to primary health sector
Description
Contacts to general practitioner or Doctor on call in the primary health sector
Time Frame
Twelve months
Title
Health related quality of life
Description
Saint George´s respiratory questionnaire, Hospital Anxiety and Depression score, SF-36 questionnaire
Time Frame
Twelve months
Title
Number of all cause contacts to primary health sector
Description
Contacts to general practitioner or Doctor on call in the primary health sector
Time Frame
Twelve months
Title
Mortality
Time Frame
During twelve months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank D Andersen, MD
Organizational Affiliation
Diagnostic Center, Regional Hospital of Silkeborg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Region Hospital of Silkeborg
City
Silkeborg
State/Province
Mid Region
ZIP/Postal Code
8600
Country
Denmark

12. IPD Sharing Statement

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Tele Health Monitoring Service for Patients With Chronic Obstructive Pulmonary Disease

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