Trial Outcomes & Findings for Feasibility Study to Use Biosensing Devices to Monitor PA and Resp. Function in Smokers w and w/o Resp. Symptoms/COPD (NCT NCT04081961)
NCT ID: NCT04081961
Last Updated: 2020-03-03
Results Overview
Recruitment is defined as the number of potential participants screened for study eligibility versus the number of persons who enrolled in the study.
Recruitment status
COMPLETED
Target enrollment
27 participants
Primary outcome timeframe
Baseline
Results posted on
2020-03-03
Participant Flow
Participant milestones
| Measure |
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
|
"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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Asymptomatic Current Smokers
n=9 Participants
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
|
"Grey Zone" Current Smokers
n=9 Participants
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
|
Current Smokers With COPD
n=9 Participants
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
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.9 years
n=9 Participants
|
50.8 years
n=9 Participants
|
51.4 years
n=9 Participants
|
51.0 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=9 Participants
|
2 Participants
n=9 Participants
|
2 Participants
n=9 Participants
|
6 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=9 Participants
|
7 Participants
n=9 Participants
|
7 Participants
n=9 Participants
|
21 Participants
n=27 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Kazakhstan
|
9 participants
n=9 Participants
|
9 participants
n=9 Participants
|
9 participants
n=9 Participants
|
27 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: The number of potential participants screened for study eligibility
Recruitment is defined as the number of potential participants screened for study eligibility versus the number of persons who enrolled in the study.
Outcome measures
| Measure |
Asymptomatic Current Smokers
n=29 Participants
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
|
"Grey Zone" Current Smokers
n=27 Participants
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
|
Current Smokers With COPD
n=21 Participants
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
|
|---|---|---|---|
|
Rate of Recruitment
|
9 Participants
|
9 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 90 daysPopulation: Participants recruited to the study
Retention is defined as the proportion of participants enrolled who completed the intervention and all study measures.
Outcome measures
| Measure |
Asymptomatic Current Smokers
n=9 Participants
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
|
"Grey Zone" Current Smokers
n=9 Participants
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
|
Current Smokers With COPD
n=9 Participants
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
|
|---|---|---|---|
|
Rate of Retention
|
9 Participants
|
9 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 90 daysAdherence to the study protocol is determined as the proportion of participants enrolled from whom all mHealth parameters registered every day.
Outcome measures
| Measure |
Asymptomatic Current Smokers
n=9 Participants
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
|
"Grey Zone" Current Smokers
n=9 Participants
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
|
Current Smokers With COPD
n=9 Participants
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
|
|---|---|---|---|
|
Protocol Adherence
|
4 Participants
|
5 Participants
|
8 Participants
|
Adverse Events
Asymptomatic Current Smokers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
"Grey Zone" Current Smokers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Current Smokers With COPD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Baurzhan Zhussupov
Kazakhstan Academy of Preventive Medicine
Phone: 87774822171
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place