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

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

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.

Study Overview

• Status: Completed
• Conditions: Signs and Symptoms, Respiratory; Mobile Applications; Respiratory Function Tests; Activity Trackers
• Intervention / Treatment: Device: Anamed OEM device; Air Next mobile spirometry device

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]).

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• Kazakhstan
  • Almaty, Kazakhstan, 050008
    • Kazakhstan Academy of Preventive Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 59 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	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
"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.	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
Current smokers with COPD; Current smokers with a confirmed diagnosis of COPD (GOLD stage I-III)	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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kazakhstan Academy of Preventive Medicine
• Collaborators: Philip Morris International; Synergy Research Group Kazakhstan
• Investigators: Principal Investigator: Almaz Sharman, Dr, Kazakhstan Academy of Preventive Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 7, 2019
• Primary Completion (ACTUAL): October 10, 2019
• Study Completion (ACTUAL): October 31, 2019

Study Registration Dates

• First Submitted: September 4, 2019
• First Submitted That Met QC Criteria: September 6, 2019
• First Posted (ACTUAL): September 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory
• Other Study ID Numbers: PMI.IIS.2016.1.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The dataset after the re-identification will be available to other researchers on the 'www.intervals.science' platform.
• IPD Sharing Time Frame: Data will be available after May 1, 2020 without time limit.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL