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

Completed

Conditions: Mobile Applications
Activity Trackers
Signs and Symptoms, Respiratory
Respiratory Function Tests

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

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 \[PEF\]).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Asymptomatic current smokers	Anamed OEM device; Air Next mobile spirometry device	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	Anamed OEM device; Air Next mobile spirometry device	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	Anamed OEM device; Air Next mobile spirometry device	Current smokers with a confirmed diagnosis of COPD (GOLD stage I-III)

Primary Outcome Measures

Name	Time	Method
Rate of Recruitment	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	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	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.