Signs and Symptoms, RespiratoryNCT04081961
Feasibility Study to Use Biosensing Devices to Monitor PA and Resp. Function in Smokers w and w/o Resp. Symptoms/COPD
An observational study of Signs and Symptoms, Respiratory and Mobile Applications, run by Kazakhstan Academy of Preventive Medicine at 1 site in Kazakhstan.
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. Read more about this study
- Who is it for?
- Ages 40 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Signs and Symptoms, Respiratory, Mobile Applications, Activity Trackers
- What is being tested?
- Anamed OEM device; Air Next mobile spirometry device
- Type of treatment
- Medical device
- How many people
- 27 participants
- Where
- 1 siteKazakhstan
- Study dates
- 7 Jun 2019to 31 Oct 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Residents of City of Almaty aged 40-59 who smoke conventional cigarettes with a minimum of 10 pack-year smoking history
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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]).
- Conditions
- Signs and Symptoms, Respiratory, Mobile Applications, Activity Trackers, Respiratory Function Tests
- Being tested
- Anamed OEM device; Air Next mobile spirometry device
- Medical subject headings
- Signs and Symptoms, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anamed OEM device; Air Next mobile spirometry deviceDevice
Anamed OEM (Original Equipment Manufacturer) device - physical activity and vital signs monitoring; Air Next mobile spirometry device
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: 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) Receives: Device: Anamed OEM device; Air Next mobile spirometry device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Rate of Retention
Retention is defined as the proportion of participants enrolled who completed the intervention and all study measures.
Measured: 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.
Measured: through study completion, an average of 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start7 Jun 2019
- Primary completion10 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Signs and Symptoms, RespiratoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kazakhstan Academy of Preventive Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Philip Morris International, Synergy Research Group
- Responsible party
- Sponsor
- Investigators
- Almaz Sharman, Dr, Principal investigator, Kazakhstan Academy of Preventive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081961
- Sponsor's protocol ID
- PMI.IIS.2016.1.
- Status last verified
- Feb 2020
- First submitted
- 4 Sep 2019
- Last updated
- 3 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: The dataset after the re-identification will be available to other researchers on the 'www.intervals.science' platform.
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.
PubMed 32213479
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04081961
- Acronym / sponsor ID
- PMI.IIS.2016.1.
- Conditions
- Signs and Symptoms, Respiratory, Mobile Applications, Activity Trackers, Respiratory Function Tests
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Kazakhstan Academy of Preventive MedicineUniversity, hospital or other
- Collaborators
- Philip Morris International, Synergy Research Group
- Study start
- 7 Jun 2019 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Posted 9 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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]).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic current smokers | – | Device: Anamed OEM device; Air Next mobile spirometry deviceNo 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 | – | Device: Anamed OEM device; Air Next mobile spirometry deviceInitially 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 | – | Device: Anamed OEM device; Air Next mobile spirometry deviceCurrent smokers with a confirmed diagnosis of COPD (GOLD stage I-III) |
Who may qualify
- Ages
- 40 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Residents of City of Almaty aged 40-59 who smoke conventional cigarettes with a minimum of 10 pack-year smoking history
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anamed OEM device; Air Next mobile spirometry deviceAnamed OEM (Original Equipment Manufacturer) device - physical activity and vital signs monitoring; Air Next mobile spirometry device | Device | "Grey zone" current smokers, Asymptomatic current smokers, Current smokers with COPD |
Primary outcome
Rate of Recruitment
Time frame: Baseline
Recruitment is defined as the number of potential participants screened for study eligibility versus the number of persons who enrolled in the study.
Rate of Retention
Time frame: through study completion, an average of 90 days
Retention is defined as the proportion of participants enrolled who completed the intervention and all study measures.
Protocol Adherence
Time frame: through study completion, an average of 90 days
Adherence to the study protocol is determined as the proportion of participants enrolled from whom all mHealth parameters registered every day.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32213479Sharman 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.
- Individual participant dataSharing planned: Yes. The dataset after the re-identification will be available to other researchers on the 'www.intervals.science' platform.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Almaz Sharman, Dr principal investigator
Kazakhstan Academy of Preventive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Signs and Symptoms, Respiratory and Mobile Applications, run by Kazakhstan Academy of Preventive Medicine at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Recruitment (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04081961, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.