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NCT03558763 | Completed | COPD


Remote Monitoring of Patients With COPD
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.

Condition or disease

COPD

Intervention/treatment

Telemonitoring

Normal Care

Phase

Not Applicable

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 Type : Interventional
Estimated Enrollment : 70 participants
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : June 7, 2018
Estimated Primary Completion Date : June 15, 2021
Estimated Study Completion Date : June 15, 2021
Arm Intervention/treatment

Active Comparator: 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.

Other: Normal Care

Active Comparator: 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.

Device: Telemonitoring

Ages Eligible for Study: 45 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

Remote Monitoring of Patients With COPD

Location Details


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Remote Monitoring of Patients With COPD

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

Sweden, Västra Götaland

COPD center

Gothenburg, Västra Götaland, Sweden, 41345

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