Remote Monitoring of Patients With COPD

Study Overview
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Brief Summary
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This clinical investigation will evaluate the patient-equipment interface and patient preference in the use of modern possibilities for remote monitoring of patients with COPD in a personalized care approach.

Detailed Description
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The primary objective is to evaluate the impact and feasibility of tele monitoring and video contact in personalized care of moderate and severe COPD patients. This should be compared to normal standards of care. The cross-over design evaluates the influence on general HRQOL of this tablet and monitoring system.

Official Title
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Remote MONITORing of Patients With Chronic Obstructive Pulmonary Disease Using a Tablet System. A Randomized Cross Over Pilot Study of Feasibility Evaluation and Quality of Life Measurements

Conditions
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COPD

Intervention / Treatment
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* Device: Telemonitoring
* Other: Normal Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willingness to participate and provision of informed consent Diagnosis of COPD FEV1/FVC (post bronchodilator) <0.7 GOLD severity grade D FEV, < 80% predicted Cognitive ability relevant for the studies as judged by the investigator Living in their own home and able to manage their activities of daily living Exclusion Criteria: Rapidly progressing severe disease other than COPD and COPD-related diseases, influencing the Health-Related Quality of Life (HRQOL) during the study time as judged by the investigator Long-term stay ( >2 weeks) away from home during the study period, where there are no possibility to get internet connection COPD exacerbation during 1 month before start of study

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This clinical trial is an open, randomized, controlled cross-over study. Eligible subjects to include will be given the possibility to participate in the study. They will at their first visit be randomized to start either telemonitoring, using the tablet system arm or to normal standard of care period for 26 weeks. After 26 weeks the subject will have a second visit and after that, four weeks (wash out) of standard of care or telemonitoring treatment. After that there will be a third visit and the subject will start the second treatment period with the alternative management. At the end of this period (56 weeks) there will be a fourth (last) visit at the center for the subject.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal Care<br>During normal care the subjects will get the possibility to call the COPD-center via telephone on their own initiative e g with worsening symptoms as usual. | Other: Normal Care<br>* During normal care the subjects will get the possibility to call the COPD-center via telephone on their own initiative e g with worsening symptoms as usual.<br>|
| Active Comparator: Telemonitoring<br>Twice a week subject will perform additional vital functions: Blood pressure and heart rate will be measured using the Electronic Sphygmomanometers Track. Weight will be taken using the Scale lite Oxygen saturation will be measured using Pulse Oximeter Air And Complete two PRO´s (integrated in the application): CAT MRC All this is estimated to take approximately 20-30 min each time. For the first 4 weeks there will be weekly video calls with a COPD-center nurse discussing health condition and vital parameters. Thereafter there will be monthly video calls with a COPD-center nurse for the remaining 5 months, i.e. 4 further calls. The video calls will take approximately 15 min. | Device: Telemonitoring<br>* During the telemonitoring treatment period the subjects will register; vital functions (blood pressure, heart rate, weight, SpO2) twice a week, physical movement daily by using a fitness device, have video calls with a nurse weekly the first 4 weeks and thereafter every fourth week the last 5 months. Twice a week (± 2 days) questionnaires (CAT and MRC) should be filled out at home.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of SF-12 over each treatment period | The primary objective is to evaluate the impact and feasibility of tele monitoring and video contact in personalized care of moderate and severe COPD patients. This should be compared to normal standards of care. The cross-over design evaluates the influence on general HRQOL of this tablet and monitoring system. | 13 month study, measure points at day 0 (1), week 26 (2), week 30 (3) and week 56 (4) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Monitoring