Remote Monitoring of Patients With COPD

NCT03558763 | Completed DMC

• 1 other identifier: MONITOR
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Keywords

Monitoring

Outcome Measures

Primary Outcomes (1)

• 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)

Other Outcomes (1)

• Cost-utility evaluation

  13 months

Study Arms (2)

Normal Care

ACTIVE COMPARATOR

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

Telemonitoring

ACTIVE COMPARATOR

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

Interventions

Telemonitoring DEVICE

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.

Telemonitoring

Normal Care OTHER

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.

Normal Care

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

COPD center

Gothenburg, Västra Götaland County, 41345, Sweden

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anders Ullman, MD Phd

  Head of COPD center

  PRINCIPAL INVESTIGATOR

• Lowie Vanfleteren, MD Phd

  Head of COPD center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This clinical trial is an open, randomized, controlled cross-over study. Eligible subjects to include will be given the possibility to participate in the study. They will at their first visit be randomized to start either telemonitoring, using the tablet system arm or to normal standard of care period for 26 weeks. After 26 weeks the subject will have a second visit and after that, four weeks (wash out) of standard of care or telemonitoring treatment. After that there will be a third visit and the subject will start the second treatment period with the alternative management. At the end of this period (56 weeks) there will be a fourth (last) visit at the center for the subject.

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 15, 2018
• Study Start: June 7, 2018
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: August 26, 2021

Record last verified: 2021-05

Locations

SE (1)