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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Care | Active Comparator | 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. |
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| Telemonitoring | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemonitoring | Device | 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. |
| 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) |
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| Measure | Description | Time Frame |
|---|---|---|
| Cost-utility evaluation | The difference in costs between the two treatments divided by the difference in quality adjusted life years (QALYs) For other secondary measures: Descriptive statistics will be used. | 13 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders Ullman, MD Phd | Head of COPD center | Principal Investigator |
| Lowie Vanfleteren, MD Phd | Head of COPD center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| COPD center | Gothenburg | Västra Götaland County | 41345 | Sweden |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 19, 2018 | May 23, 2018 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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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.
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| Normal Care | Other | 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. |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |