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Advanced Telemonitoring of Patients With COPD in Home Environment

SHAPES Advanced Telemonitoring of Patients With COPD in Home Environment

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05269043
Enrollment
25
Registered
2022-03-07
Start date
2022-10-14
Completion date
2023-02-01
Last updated
2024-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Brief summary

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.

Interventions

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.

Sponsors

University Hospital Olomouc
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frameDescription
Telemetric spirometry - FVC3 monthEvaluation of telemetric measurement of FVC in home enviroment in COPD patients wih use of mobile spirometer
Telemetric spirometry - PEF3 monthEvaluation of telemetric measurement of PEF in home enviroment in COPD patients wih use of mobile spirometer
Telemetric spirometry - FEV1%3 monthEvaluation of telemetric measurement of FEV1% in home enviroment in COPD patients wih use of mobile spirometer
Telemetric spirometry - FEV1%/FVC ratio3 monthEvaluation of telemetric measurement of FEV1%/FVC ratio in home enviroment in COPD patients wih use of mobile spirometer
Blood oxygen saturation monitoring3 monthContinuous measurement of blood oxygen saturation in the study group.
Particulate matter concentration monitoring3 monthContinuous 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.
Environmental monitoring3 monthContinuous measurement of selected environmental parameters (humidity and temperature) - in both outdoor and indoor conditions.
Adherence monitoring - rate of inhalations per day3 monthThe 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.
Adherence monitoring - time of inhalation deviation3 monthThe 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.

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026