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

Overview

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 symptoms/COPD (e.g., heart rate, blood oxygenation, steps/motion) for a future big-scale study.

Full Title of Study: “A Proof-of-concept, Open-label, Feasibility Study to Evaluate Mobile Applications and Biosensing (mHealth) Devices to Monitor Physical Activity and Respiratory Function in Smokers With and Without Respiratory Symptoms/COPD”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 10, 2019

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 study aims to reveal and address the anticipated barriers to the acceptance and implementation of mHealth devices in this patient population and clinical setting. As is well documented, the more attention patients receive from medical personnel, the better their clinical outcomes. Here we are attempting to use device-driven monitoring applications, interactive reminders, and teaching modules to deliver a constant positive feedback loop to patients to improve their health decisions.

Objectives of the study:

To assess the feasibility of using mHealth devices in current smokers with and without respiratory symptoms/COPD.

To assess the utility (i.e., validity and reproducibility) of mHealth devices in detecting vitality parameters in current smokers with and without respiratory symptoms/COPD (e.g., heart rate; blood oxygenation; steps/motion; FEV1, FVC, and their ratio; peak expiratory flow [PEF]).

Interventions

  • Device: Anamed OEM device; Air Next mobile spirometry device
    • Anamed OEM (Original Equipment Manufacturer) device – physical activity and vital signs monitoring; Air Next mobile spirometry device

Arms, Groups and Cohorts

  • Asymptomatic current smokers
    • No respiratory symptoms and preserved pulmonary function based on spirometry (FEV1/FVC of at least 0.70 after bronchodilation treatment and FVC ≥80% of the expected value)
  • “Grey zone” current smokers
    • Initially preserved pulmonary function based on spirometry, but with clinical symptoms based on COPD Assessment Test (CAT≥10) and results of the 6-min walk test (6 MWT) less than 450 meters.
  • Current smokers with COPD
    • Current smokers with a confirmed diagnosis of COPD (GOLD stage I-III)

Clinical Trial Outcome Measures

Primary Measures

  • Rate of Recruitment
    • Time Frame: Baseline
    • Recruitment is defined as the number of potential participants screened for study eligibility versus the number of persons who enrolled in the study.
  • Rate of Retention
    • Time Frame: through study completion, an average of 90 days
    • Retention is defined as the proportion of participants enrolled who completed the intervention and all study measures.
  • Protocol Adherence
    • Time Frame: through study completion, an average of 90 days
    • Adherence to the study protocol is determined as the proportion of participants enrolled from whom all mHealth parameters registered every day.

Participating in This Clinical Trial

Inclusion Criteria

  • 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 Criteria

  • 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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 59 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Kazakhstan Academy of Preventive Medicine
  • Collaborator
    • Philip Morris International
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Almaz Sharman, Dr, Principal Investigator, Kazakhstan Academy of Preventive Medicine

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