Advanced Telemonitoring of Patients With COPD in Home Environment

COPD Clinical Trial

Official title:

SHAPES Advanced Telemonitoring of Patients With COPD in Home Environment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05269043
• Other study ID #: SHAPES UC-PT3-COPD
• Status: Completed
• Start date: October 14, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: January 2024
• Source: University Hospital Olomouc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• COPD

Intervention

Device:
• Medimonitor
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.

Locations

Country	Name	City	State
Czechia	Department of Respiratory Medicine, University Hospital Olomouc, Czech Republic	Olomouc

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Olomouc

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Telemetric spirometry - FVC	Evaluation of telemetric measurement of FVC in home enviroment in COPD patients wih use of mobile spirometer	3 month
Primary	Telemetric spirometry - PEF	Evaluation of telemetric measurement of PEF in home enviroment in COPD patients wih use of mobile spirometer	3 month
Primary	Telemetric spirometry - FEV1%	Evaluation of telemetric measurement of FEV1% in home enviroment in COPD patients wih use of mobile spirometer	3 month
Primary	Telemetric spirometry - FEV1%/FVC ratio	Evaluation of telemetric measurement of FEV1%/FVC ratio in home enviroment in COPD patients wih use of mobile spirometer	3 month
Primary	Blood oxygen saturation monitoring	Continuous measurement of blood oxygen saturation in the study group.	3 month
Primary	Particulate matter concentration monitoring	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.	3 month
Primary	Environmental monitoring	Continuous measurement of selected environmental parameters (humidity and temperature) - in both outdoor and indoor conditions.	3 month
Primary	Adherence monitoring - rate of inhalations per day	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.	3 month
Primary	Adherence monitoring - time of inhalation deviation	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.	3 month