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

NCT04081961 | Completed Results

• 1 other identifier: PMI.IIS.2016.1.
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

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

"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

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

Interventions

Anamed OEM device; Air Next mobile spirometry device DEVICE

Anamed OEM (Original Equipment Manufacturer) device - physical activity and vital signs monitoring; Air Next mobile spirometry device

"Grey zone" current smokers; Asymptomatic current smokers; Current smokers with COPD

Eligibility Criteria

• Age: 40 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kazakhstan Academy of Preventive Medicine: lead
• Philip Morris International: collaborator
• Synergy Research Group: collaborator

Study Sites (1)

Kazakhstan Academy of Preventive Medicine

Almaty, 050008, Kazakhstan

Location

Related Publications (1)

• 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.

  PMID: 32213479 DERIVED

MeSH Terms

Conditions

Signs and Symptoms, Respiratory

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Baurzhan Zhussupov
• Organization: Kazakhstan Academy of Preventive Medicine

baurzhan.zhussupov@gmail.com

87774822171

Study Officials

• Almaz Sharman, Dr

  Kazakhstan Academy of Preventive Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 9, 2019
• Study Start: June 7, 2019
• Primary Completion: October 10, 2019
• Study Completion: October 31, 2019
• Last Updated: March 3, 2020
• Results First Posted: January 9, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after May 1, 2020 without time limit.

Locations

KA (1)