Remote Monitoring of Patients With COPD

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2019

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 45 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vastra Gotaland Region
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Anders Ullman, MD Phd, Principal Investigator, Head of COPD center
  • Overall Contact(s)
    • Anneli Crespo, +46722104712, anneli.crespo@vgregion.se

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