Remote Monitoring of Patients With COPD

Not Applicable

Completed

• Conditions: COPD
• Interventions: Other: Normal Care; Device: Telemonitoring

• Registration Number: NCT03558763
• Lead Sponsor: Vastra Gotaland Region

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.

Study Timeline

• Study First Submitted: 2018-05-23
• Study Start: 2018-06-07
• Study First Submitted QC: 2018-06-14
• Study First Posted: 2018-06-15
• Status Verified: 2021-05
• Primary Completion: 2021-06-15
• Study Completion: 2021-06-15
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Normal Care	Normal 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.
Telemonitoring	Telemonitoring	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

COPD center; 🇸🇪 Gothenburg, Västra Götaland, Sweden