Have you or your loved ones been diagnosed with chronic obstructive pulmonary disease, copd?

You may be eligible to participate in a chronic obstructive pulmonary disease, copd clinical trial.

Have you or your loved ones been diagnosed with chronic obstructive pulmonary disease, copd? You may be eligible to participate in a chronic obstructive pulmonary disease, copd clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Chronic Obstructive Pulmonary Disease, COPD Clinical Trial in Silkeborg Mid Region

NCT02615795 | Interventional

Have you or your loved ones been diagnosed with chronic obstructive pulmonary disease, copd?

You may be eligible to participate in a chronic obstructive pulmonary disease, copd clinical trial.

Have you or your loved ones been diagnosed with chronic obstructive pulmonary disease, copd? You may be eligible to participate in a chronic obstructive pulmonary disease, copd clinical trial.

Completed

Male & Female

40 Years +

This study has recruited 160 Participants

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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Details for the study

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

Brief Summary

The aim of this study is to evaluate the effect of monitoring patients with chronic<br /> obstructive pulmonary disease (COPD) after a hospitalization for COPD exacerbation or<br /> pneumonia. The patients are randomized to receive either standard treatment and follow up, or<br /> standard treatment and follow up, plus tele monitoring of key clinical parameters and<br /> 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.

Treatments and/or Procedures

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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

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

Health related quality of life

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

Twelve months

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

Sensitivity of physiological measurements in detecting COPD exacerbation

Relation between physiological measurements and COPD exacerbation

During six months of intervention

Secondary

Number of self-addressed COPD exacerbations

Without primary contact to medical staff

Twelve months

Study 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