COPD
Conditions
Keywords
Monitoring
Brief summary
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
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.
Interventions
DEVICETelemonitoring
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.
OTHERNormal Care
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.
Sponsors
Vastra Gotaland Region
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of SF-12 over each treatment period | 13 month study, measure points at day 0 (1), week 26 (2), week 30 (3) and week 56 (4) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cost-utility evaluation | 13 months | 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. |
Countries
Sweden
Outcome results
None listed