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

Kazakhstan Academy of Preventive Medicine

Status: Completed

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

Treatments: Device: Anamed OEM device; Air Next mobile spirometry device

Study type: Observational

Funder types: Other

Identifiers

NCT04081961

PMI.IIS.2016.1.

Details and patient eligibility

About

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 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]).

Enrollment: 27 patients

Sex: All

Ages: 40 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

27 participants in 3 patient groups

Asymptomatic current smokers

Description:

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)

Treatment:

Device: Anamed OEM device; Air Next mobile spirometry device

"Grey zone" current smokers

Description:

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.

Treatment:

Device: Anamed OEM device; Air Next mobile spirometry device

Current smokers with COPD

Description:

Current smokers with a confirmed diagnosis of COPD (GOLD stage I-III)

Treatment:

Device: Anamed OEM device; Air Next mobile spirometry device