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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COPD
- Sponsor
- Vastra Gotaland Region
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Change of SF-12 over each treatment period
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Change of SF-12 over each treatment period
Time Frame: 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.