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| Name | Class |
|---|---|
| Philip Morris International | INDUSTRY |
| Synergy Research Group | INDUSTRY |
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.
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]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
| |
| "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. |
| |
| Current smokers with COPD | Current smokers with a confirmed diagnosis of COPD (GOLD stage I-III) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Residents of City of Almaty aged 40-59 who smoke conventional cigarettes with a minimum of 10 pack-year smoking history
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| Name | Affiliation | Role |
|---|---|---|
| Almaz Sharman, Dr | Kazakhstan Academy of Preventive Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kazakhstan Academy of Preventive Medicine | Almaty | 050008 | Kazakhstan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32213479 | Derived | 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. |
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The dataset after the re-identification will be available to other researchers on the 'www.intervals.science' platform.
Data will be available after May 1, 2020 without time limit.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 3, 2019 | Dec 18, 2019 |
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| FG001 | "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. 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 |
| FG002 | Current Smokers With COPD | Current smokers with a confirmed diagnosis of COPD (GOLD stage I-III) 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) 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 |
| BG001 | "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. 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 |
| BG002 | Current Smokers With COPD | Current smokers with a confirmed diagnosis of COPD (GOLD stage I-III) 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 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The number of potential participants screened for study eligibility | Posted | Count of Participants | Participants | Baseline |
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| Primary | Rate of Retention | Retention is defined as the proportion of participants enrolled who completed the intervention and all study measures. | Participants recruited to the study | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | through study completion, an average of 90 days |
|
90 days after participant was recruited to the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) 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 | 0 | 9 | 0 | 9 | 0 | 9 |
| EG001 | "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. 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 | 0 | 9 | 0 | 9 | 0 | 9 |
| EG002 | Current Smokers With COPD | Current smokers with a confirmed diagnosis of COPD (GOLD stage I-III) 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 | 0 | 9 | 0 | 9 | 0 | 9 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Baurzhan Zhussupov | Kazakhstan Academy of Preventive Medicine | 87774822171 | baurzhan.zhussupov@gmail.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 14, 2019 | Dec 18, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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