Clinical trial NCT03558763: Remote Monitoring of Patients With COPD
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: Monitoring
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2018-06-15
Enrollment: 70
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of SF-12 over each treatment period
timeFrame: 13 month study, measure points at day 0 (1), week 26 (2), week 30 (3) and week 56 (4)
Secondary outcomes:
Other outcomes:
measure: Cost-utility evaluation
timeFrame: 13 months
Locations:
city: Gothenburg
country: Sweden
facility: COPD center
state: Västra Götaland
Study officials:
affiliation: Head of COPD center
name: Anders Ullman, MD Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Head of COPD center
name: Lowie Vanfleteren, MD Phd
role: PRINCIPAL_INVESTIGATOR
References: