Remote Monitoring of Patients With COPD

COPD Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03558763
• Other study ID #: MONITOR
• Status: Completed
• Phase: N/A
• Start date: June 7, 2018
• Est. completion date: June 15, 2021

Study information

• Verified date: May 2021
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 15, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

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.

Other:
• 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.

Locations

Country	Name	City	State
Sweden	COPD center	Gothenburg	Västra Götaland

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	13 months
Primary	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.	13 month study, measure points at day 0 (1), week 26 (2), week 30 (3) and week 56 (4)