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Completed

NCT Number: NCT05269043

Advanced Telemonitoring of Patients With COPD in Home Environment

Chronic obstructive pulmonary disease (COPD) is one of the leading and rising causes of morbidity and mortality worldwide. The most important etiopathogenetic agent is smoking. However, air-pollution probably also plays a crucial role in the disease development, progression and exacerbations. The multimodal-telemedicine approach may provide a useful tool in the patient follow-up with the aim to reduce disease exacerbation rate and improve the health-related quality of life. The study aims to investigate the effects and utility of advanced telemonitoring in elderly COPD patients. All data will be integrated in a single web-based platform in order to analyse the mutual effects of different conditions and variables.

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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

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Respiratory Medicine, University Hospital Olomouc, Czech Republic

Olomouc, 77900, Czechia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • COPD
  • ≥ 60 years of age
  • Informed written and verbal consent
  • Ability to participate in study activities

Exclusion criteria

  • Active smoking
  • Respiratory failure requiring oxygenotherapy or ventilation support
  • Severe psychological disturbances
  • Absence of collaboration (informed consent)
  • Other comorbid pulmonary disease
  • Symptomatic heart failure
  • Motor neuron diseases (e.g. amyotrophic lateral sclerosis etc.)

Treatment and study plan

Medimonitor

Device

A digital solution consisting of smartphone/tablet based application gathering data from medical and other devices provided to the patients. These devices are as follows: tablet, smart inhaler, spirometer, blood pressure monitor, pulse oximetry device, particulate matter sensor.

Primary outcomes

  1. Telemetric spirometry - FVC

    Time frame: 3 month

    Evaluation of telemetric measurement of FVC in home enviroment in COPD patients wih use of mobile spirometer

  2. Telemetric spirometry - PEF

    Time frame: 3 month

    Evaluation of telemetric measurement of PEF in home enviroment in COPD patients wih use of mobile spirometer

  3. Telemetric spirometry - FEV1%

    Time frame: 3 month

    Evaluation of telemetric measurement of FEV1% in home enviroment in COPD patients wih use of mobile spirometer

  4. Telemetric spirometry - FEV1%/FVC ratio

    Time frame: 3 month

    Evaluation of telemetric measurement of FEV1%/FVC ratio in home enviroment in COPD patients wih use of mobile spirometer

  5. Blood oxygen saturation monitoring

    Time frame: 3 month

    Continuous measurement of blood oxygen saturation in the study group.

  6. Particulate matter concentration monitoring

    Time frame: 3 month

    Continuous measurement of both indoor and outdoor air-pollution levels via monitoring of selected parameters (PM1.0, PM2.5, PM4.0, PM10). and some other selected environmental parameters (humidity and temperature) - as well in both outdoor and indoor conditions.

  7. Environmental monitoring

    Time frame: 3 month

    Continuous measurement of selected environmental parameters (humidity and temperature) - in both outdoor and indoor conditions.

  8. Adherence monitoring - rate of inhalations per day

    Time frame: 3 month

    The regular monitoring of the patients' adherence to the inhaled therapy, using FindAir smart inhaler technology. Rate of inhalations per day is measured via special cap mounted on the top of the inhaler which is detecting each activation while pressing the cap. Result is being compared with the amount of inhalations recommended by the physician.

  9. Adherence monitoring - time of inhalation deviation

    Time frame: 3 month

    The regular monitoring of the patients' adherence to the inhaled therapy, using FindAir smart inhaler technology. A specific time of inhalation is being recorded by a special cap mounted on the top of the inhaler which is detecting each activation while pressing the cap. Deviation between recommended time of inhalation and real time of inhalation is being monitored through the study.

Sponsors and collaborators

Lead sponsor

University Hospital Olomouc

Other

Registry information

Official study title

SHAPES Advanced Telemonitoring of Patients With COPD in Home Environment

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 7, 2022
Registry last updated
Jan 29, 2024

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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