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Completed

NCT Number: NCT02615795

Tele Health Monitoring Service for Patients With Chronic Obstructive Pulmonary Disease

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease, COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Region Hospital of Silkeborg

Silkeborg, Mid Region, 8600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tele Monitoring, using Tunstall monitoring device

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

Primary outcomes

  1. Number of hospitalization days

    Time frame: During twelve months

Secondary outcomes

  1. Duration of COPD related hospitalizations, in days

    Time frame: Twelve months

  2. Number of hospitalizations caused by COPD exacerbation

    Time frame: During twelve months

  3. Number of COPD related contacts to emergency rooms

    Time frame: Twelve months

  4. Number of self-addressed COPD exacerbations

    Time frame: Twelve months

    Without primary contact to medical staff

  5. Sensitivity of physiological measurements in detecting COPD exacerbation

    Time frame: During six months of intervention

    Relation between physiological measurements and COPD exacerbation

  6. Number of unplanned contact to primary health sector

    Time frame: Twelve months

    Contacts to general practitioner or Doctor on call in the primary health sector

  7. Health related quality of life

    Time frame: Twelve months

    Saint George´s respiratory questionnaire, Hospital Anxiety and Depression score, SF-36 questionnaire

  8. Number of all cause contacts to primary health sector

    Time frame: Twelve months

    Contacts to general practitioner or Doctor on call in the primary health sector

  9. Mortality

    Time frame: During twelve months

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Nov 26, 2015
Registry last updated
Oct 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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