Status:

COMPLETED

Feasibility Study to Use Biosensing Devices to Monitor PA and Resp. Function in Smokers w and w/o Resp. Symptoms/COPD

Lead Sponsor:

Kazakhstan Academy of Preventive Medicine

Collaborating Sponsors:

Philip Morris International

Synergy Research Group

Conditions:

Signs and Symptoms, Respiratory

Mobile Applications

Eligibility:

All Genders

40-59 years

Brief Summary

This study examines the feasibility and acceptability of using mobile applications and biosensing (mHealth) devices in detecting vitality parameters in current smokers with and without respiratory sym...

Detailed Description

The study is designed to investigate feasibility of using mHealth devices to improve the treatment, assessment, compliance, and outcomes in smokers with and without respiratory symptoms/COPD. The stud...

Eligibility Criteria

Inclusion

  • Current smokers who are currently smoking conventional cigarettes with a minimum of 10 pack-year smoking history
  • Able to use and willing to be trained to use mHealth devices

Exclusion

  • COPD exacerbation that has not resolved at least 28 days prior to screening
  • COPD exacerbation occurring after screening but before the first study visit
  • Pneumonia or other respiratory tract infections that have not resolved at least 14 days prior to screening
  • Pneumonia occurring after screening but before the first study visit
  • Active respiratory disorders: tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, bronchial asthma, lung fibrosis, pulmonary hypertension, interstitial lung diseases, or other active pulmonary diseases
  • Any co-morbid medical condition that in the opinion of the investigator would make participation in the study unsafe or unfeasible, including conditions that prohibit completion of exercise testing
  • Use of supplemental oxygen therapy
  • Inability to abstain from smoking during the period in which the participant is admitted to the Kazakhstan Academy of Preventive Medicine (KAPM) COPD Center
  • A history of allergy or hypersensitivity to metal, particularly stainless steel
  • Any vital sign indicator, for example, hypertension or tachycardia at rest that, at the discretion of the investigator, would make participation in the study unsafe or unfeasible
  • Women who test positive for pregnancy during screening, lactating women, or women planning on becoming pregnant during the study
  • Participants using assistive devices like walking aids, as these are likely to interfere with physical activity

Key Trial Info

Start Date :

June 7 2019

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

October 31 2019

Estimated Enrollment :

27 Patients enrolled

Trial Details

Trial ID

NCT04081961

Start Date

June 7 2019

End Date

October 31 2019

Last Update

March 3 2020

Active Locations (1)

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Kazakhstan Academy of Preventive Medicine

Almaty, Kazakhstan, 050008