Clinical trial NCT04081961: Feasibility Study to Use Biosensing Devices to Monitor PA and Resp. Function in Smokers w and w/o Resp. Symptoms/COPD
Official title: 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: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Signs and Symptoms, Respiratory
Mobile Applications
Activity Trackers
Respiratory Function Tests
Lead sponsor: Kazakhstan Academy of Preventive Medicine
Sponsor class: OTHER
Collaborators: name: Philip Morris International
name: Synergy Research Group
First posted: 2019-09-09
Enrollment: 27
Sex: ALL
Minimum age (years): 40
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of City of Almaty aged 40-59 who smoke conventional cigarettes with a minimum of 10 pack-year smoking history

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 \[PEF\]).

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Recruitment
timeFrame: Baseline
measure: Rate of Retention
timeFrame: through study completion, an average of 90 days
measure: Protocol Adherence
timeFrame: through study completion, an average of 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Kazakhstan Academy of Preventive Medicine
Study officials:
affiliation: Kazakhstan Academy of Preventive Medicine
name: Almaz Sharman, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sharman A, Zhussupov B, Sharman D, Kim I. Evaluating Mobile Apps and Biosensing Devices to Monitor Physical Activity and Respiratory Function in Smokers With and Without Respiratory Symptoms or Chronic Obstructive Pulmonary Disease: Protocol for a Proof-of-Concept, Open-Label, Feasibility Study. JMIR Res Protoc. 2020 Mar 26;9(3):e16461. doi: 10.2196/16461.