Trial Outcomes & Findings for Enhanced Community-Based Asthma Monitoring Through Novel Technology (NCT NCT05824936)
NCT ID: NCT05824936
Last Updated: 2025-05-20
Results Overview
Feasibility will be evaluated by calculating retention rates at week 24.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
24 weeks
Results posted on
2025-05-20
Participant Flow
Participant milestones
| Measure |
Pilot Study Arm for Technology-enhanced Asthma Intervention
All participants will be in the pilot arm for technology-enhanced intervention program.
Pilot study arm for technology-enhanced asthma intervention: Participants will be enrolled in a remote monitoring program using monthly remote study visits which will include the use of a mobile spirometer (device for testing lung function). Participants will complete monthly remote study visits visits using telehealth platform and will complete lung function testing during the visit using a mobile spirometer as well as remote study measures.
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|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Pilot Study Arm for Technology-enhanced Asthma Intervention
All participants will be in the pilot arm for technology-enhanced intervention program.
Pilot study arm for technology-enhanced asthma intervention: Participants will be enrolled in a remote monitoring program using monthly remote study visits which will include the use of a mobile spirometer (device for testing lung function). Participants will complete monthly remote study visits visits using telehealth platform and will complete lung function testing during the visit using a mobile spirometer as well as remote study measures.
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|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Enhanced Community-Based Asthma Monitoring Through Novel Technology
Baseline characteristics by cohort
| Measure |
Pilot Study Arm for Technology-enhanced Asthma Intervention
n=15 Participants
All participants will be in the pilot arm for technology-enhanced intervention program.
Pilot study arm for technology-enhanced asthma intervention: Participants will be enrolled in a remote monitoring program using monthly remote study visits which will include the use of a mobile spirometer (device for testing lung function). Participants will complete monthly remote study visits visits using telehealth platform and will complete lung function testing during the visit using a mobile spirometer as well as remote study measures.
|
|---|---|
|
Age, Categorical
<=18 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Participants who completed the pilot through final study visit.
Feasibility will be evaluated by calculating retention rates at week 24.
Outcome measures
| Measure |
Pilot Study Arm for Technology-enhanced Asthma Intervention
n=15 Participants
All participants will be in the pilot arm for technology-enhanced intervention program.
Pilot study arm for technology-enhanced asthma intervention: Participants will be enrolled in a remote monitoring program using monthly remote study visits which will include the use of a mobile spirometer (device for testing lung function). Participants will complete monthly remote study visits visits using telehealth platform and will complete lung function testing during the visit using a mobile spirometer as well as remote study measures.
|
Participants Who Did Not Complete Pilot
Participants who did not complete pilot.
|
|---|---|---|
|
Feasibility (Retention %)
|
14 Participants
|
—
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Results of Satisfaction and Usability Survey for 12 participants who completed the pilot and also completed this measure.
To measure acceptability, the study-specific Satisfaction and Usability Survey will be used and assessed at item-level. The percentage (%) of participants who respond "agree" or "strongly agree" to each item will be measured.
Outcome measures
| Measure |
Pilot Study Arm for Technology-enhanced Asthma Intervention
n=12 Participants
All participants will be in the pilot arm for technology-enhanced intervention program.
Pilot study arm for technology-enhanced asthma intervention: Participants will be enrolled in a remote monitoring program using monthly remote study visits which will include the use of a mobile spirometer (device for testing lung function). Participants will complete monthly remote study visits visits using telehealth platform and will complete lung function testing during the visit using a mobile spirometer as well as remote study measures.
|
Participants Who Did Not Complete Pilot
Participants who did not complete pilot.
|
|---|---|---|
|
Acceptability
It was easy to use
|
12 Participants
|
—
|
|
Acceptability
It was convenient to use
|
12 Participants
|
—
|
|
Acceptability
The time spent was just about right.
|
12 Participants
|
—
|
|
Acceptability
The introduction and training was enough.
|
12 Participants
|
—
|
|
Acceptability
I would recommend the program to others.
|
12 Participants
|
—
|
|
Acceptability
It helped me change my asthma habits.
|
11 Participants
|
—
|
|
Acceptability
It helped me to understand the importance of following my asthma plan.
|
10 Participants
|
—
|
|
Acceptability
It helped me to understand how to control my asthma.
|
10 Participants
|
—
|
|
Acceptability
It helped me to manage my asthma in a way that I could not have done myself.
|
10 Participants
|
—
|
|
Acceptability
It helped me to understand my asthma better.
|
11 Participants
|
—
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Remote visits (5 total) of 14 participants who completed pilot were analyzed for technical concerns.
The frequency (%) of any technical or connectivity issues at each visit will be recorded throughout the study.
Outcome measures
| Measure |
Pilot Study Arm for Technology-enhanced Asthma Intervention
n=70 Remote study visits
All participants will be in the pilot arm for technology-enhanced intervention program.
Pilot study arm for technology-enhanced asthma intervention: Participants will be enrolled in a remote monitoring program using monthly remote study visits which will include the use of a mobile spirometer (device for testing lung function). Participants will complete monthly remote study visits visits using telehealth platform and will complete lung function testing during the visit using a mobile spirometer as well as remote study measures.
|
Participants Who Did Not Complete Pilot
Participants who did not complete pilot.
|
|---|---|---|
|
Accessibility
Visits without technical challenges
|
61 Remote study visits
|
—
|
|
Accessibility
Visits with Technical Challenges
|
9 Remote study visits
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ACT of 14 participants who completed the pilot were analyzed.
The asthma control test (ACT) will be completed at each study visit. This measure rates asthma symptoms from 5-25 with 5 being the lowest (poorest) asthma control and 25 being the highest (optimal) asthma control.
Outcome measures
| Measure |
Pilot Study Arm for Technology-enhanced Asthma Intervention
n=14 Participants
All participants will be in the pilot arm for technology-enhanced intervention program.
Pilot study arm for technology-enhanced asthma intervention: Participants will be enrolled in a remote monitoring program using monthly remote study visits which will include the use of a mobile spirometer (device for testing lung function). Participants will complete monthly remote study visits visits using telehealth platform and will complete lung function testing during the visit using a mobile spirometer as well as remote study measures.
|
Participants Who Did Not Complete Pilot
Participants who did not complete pilot.
|
|---|---|---|
|
Explore the Preliminary Effectiveness of the Pilot Program on Asthma Control.
Baseline ACT -Week 0 (median)
|
23 score on a scale
Interval 14.0 to 25.0
|
—
|
|
Explore the Preliminary Effectiveness of the Pilot Program on Asthma Control.
Final ACT- Week 24 (median)
|
22 score on a scale
Interval 12.0 to 25.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ESS-CHAD scores of all participants who completed the pilot.
The Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD) will be completed at each study visit. This measure rates sleepiness with scores of 0-24 with 0 being the lowest degree of daytime sleepiness and 24 being the highest (sleepiest).
Outcome measures
| Measure |
Pilot Study Arm for Technology-enhanced Asthma Intervention
n=14 Participants
All participants will be in the pilot arm for technology-enhanced intervention program.
Pilot study arm for technology-enhanced asthma intervention: Participants will be enrolled in a remote monitoring program using monthly remote study visits which will include the use of a mobile spirometer (device for testing lung function). Participants will complete monthly remote study visits visits using telehealth platform and will complete lung function testing during the visit using a mobile spirometer as well as remote study measures.
|
Participants Who Did Not Complete Pilot
Participants who did not complete pilot.
|
|---|---|---|
|
Explore the Preliminary Effectiveness of the Pilot Program on Daytime Sleepiness.
Baseline Week 0 ESS-CHAD (Median)
|
6 score on a scale
Interval 0.0 to 14.0
|
—
|
|
Explore the Preliminary Effectiveness of the Pilot Program on Daytime Sleepiness.
Final- Week 24 ESS-CHAD (median)
|
4 score on a scale
Interval 0.0 to 15.0
|
—
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Characteristics of participants who completed pilot were analyzed.
The study-specific demographic and psychosocial assessment tool will be completed at the baseline visit. Descriptive and comparative statistics will be employed to characterize participant-specific demographic factors which may be associated with study completion at item-level.
Outcome measures
| Measure |
Pilot Study Arm for Technology-enhanced Asthma Intervention
n=14 Participants
All participants will be in the pilot arm for technology-enhanced intervention program.
Pilot study arm for technology-enhanced asthma intervention: Participants will be enrolled in a remote monitoring program using monthly remote study visits which will include the use of a mobile spirometer (device for testing lung function). Participants will complete monthly remote study visits visits using telehealth platform and will complete lung function testing during the visit using a mobile spirometer as well as remote study measures.
|
Participants Who Did Not Complete Pilot
n=1 Participants
Participants who did not complete pilot.
|
|---|---|---|
|
Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention.
Ethnicity: Hispanic
|
3 Participants
|
0 Participants
|
|
Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention.
Ethnicity: Non-Hispanic
|
11 Participants
|
1 Participants
|
|
Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention.
Sex: Male
|
4 Participants
|
1 Participants
|
|
Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention.
Sex: Female
|
10 Participants
|
0 Participants
|
|
Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention.
Race: White
|
7 Participants
|
0 Participants
|
|
Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention.
Race: Black or African-American
|
4 Participants
|
1 Participants
|
|
Explore Patient and Family-related Demographic Characteristics and Psychosocial Factors Associated With Successful Completion of the Intervention.
Race: More than one race
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Asthma-related baseline characteristics of participants who completed vs. did not complete the pilot were compared and analyzed.
Asthma-related factors associated with successful completion of the intervention will be analyzed and compared to participants who do not complete the intervention. Courses of oral steroids in the prior 6 months were calculated based on participant survey results.
Outcome measures
| Measure |
Pilot Study Arm for Technology-enhanced Asthma Intervention
n=14 Participants
All participants will be in the pilot arm for technology-enhanced intervention program.
Pilot study arm for technology-enhanced asthma intervention: Participants will be enrolled in a remote monitoring program using monthly remote study visits which will include the use of a mobile spirometer (device for testing lung function). Participants will complete monthly remote study visits visits using telehealth platform and will complete lung function testing during the visit using a mobile spirometer as well as remote study measures.
|
Participants Who Did Not Complete Pilot
n=1 Participants
Participants who did not complete pilot.
|
|---|---|---|
|
Explore Asthma-related Factors Associated With Successful Completion of the Intervention (Oral Steroid Usage)
|
1 Courses
Interval 0.0 to 10.0
|
0 Courses
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: Asthma-related baseline characteristics of participants who completed vs. did not complete the pilot were compared and analyzed.
Asthma-related factors associated with successful completion of the intervention will be analyzed and compared to participants who do not complete the intervention. Number of ER visits were calculated based on survey results
Outcome measures
| Measure |
Pilot Study Arm for Technology-enhanced Asthma Intervention
n=14 Participants
All participants will be in the pilot arm for technology-enhanced intervention program.
Pilot study arm for technology-enhanced asthma intervention: Participants will be enrolled in a remote monitoring program using monthly remote study visits which will include the use of a mobile spirometer (device for testing lung function). Participants will complete monthly remote study visits visits using telehealth platform and will complete lung function testing during the visit using a mobile spirometer as well as remote study measures.
|
Participants Who Did Not Complete Pilot
n=1 Participants
Participants who did not complete pilot.
|
|---|---|---|
|
Explore Asthma-related Factors Associated With Successful Completion of the Intervention (ER Visits)
|
1 ER visits
Interval 0.0 to 10.0
|
0 ER visits
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: Asthma-related baseline characteristics of participants who completed vs. did not complete the pilot were compared and analyzed.
Asthma-related factors associated with successful completion of the intervention will be analyzed and compared to participants who do not complete the intervention. Hospital admissions were calculated based on survey results.
Outcome measures
| Measure |
Pilot Study Arm for Technology-enhanced Asthma Intervention
n=14 Participants
All participants will be in the pilot arm for technology-enhanced intervention program.
Pilot study arm for technology-enhanced asthma intervention: Participants will be enrolled in a remote monitoring program using monthly remote study visits which will include the use of a mobile spirometer (device for testing lung function). Participants will complete monthly remote study visits visits using telehealth platform and will complete lung function testing during the visit using a mobile spirometer as well as remote study measures.
|
Participants Who Did Not Complete Pilot
n=1 Participants
Participants who did not complete pilot.
|
|---|---|---|
|
Explore Asthma-related Factors Associated With Successful Completion of the Intervention (Hospital Admissions)
|
0 Admissions
Interval 0.0 to 5.0
|
0 Admissions
Interval 0.0 to 0.0
|
Adverse Events
Pilot Study Arm for Technology-enhanced Asthma Intervention
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place