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Completed

NCT Number: NCT03558763

Remote Monitoring of Patients With COPD

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.

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Key information

Conditions

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

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

COPD center

Gothenburg, Västra Götaland County, 41345, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Other outcomes

  1. Cost-utility evaluation

    Time frame: 13 months

    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.

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study 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

Acronym: COPD

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 15, 2018
Registry last updated
Aug 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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