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

Mobile Applications Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04081961
• Other study ID #: PMI.IIS.2016.1.
• Status: Completed
• Start date: June 7, 2019
• Est. completion date: October 31, 2019

Study information

• Verified date: February 2020
• Source: Kazakhstan Academy of Preventive Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 31, 2019
• Est. primary completion date: October 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 59 Years

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

Related Conditions & MeSH terms

• Activity Trackers
• Mobile Applications
• Respiratory Function Tests
• Signs and Symptoms
• Signs and Symptoms, Respiratory

Intervention

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

Locations

Country	Name	City	State
Kazakhstan	Kazakhstan Academy of Preventive Medicine	Almaty

Sponsors (3)

Lead Sponsor	Collaborator
Kazakhstan Academy of Preventive Medicine	Philip Morris International, Synergy Research Group Kazakhstan

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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