An interventional study of Telemonitoring and Normal Care in COPD, sponsored by Vastra Gotaland Region. Completed at 1 site in Sweden. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2021-08-26.
Sponsored by Vastra Gotaland Region · Not applicable, Interventional, and Prevention
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.
Vastra Gotaland Region is the lead sponsor of 267 studies on the registry; 107 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
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.
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.
Time frame: 13 month study, measure points at day 0 (1), week 26 (2), week 30 (3) and week 56 (4)
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.
Time frame: 13 months
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Vastra Gotaland Region