Trial Outcomes & Findings for Managing AsThma AnD Obesity Related Symptoms (MATADORS) Feasibility Study (NCT NCT05742646)
NCT ID: NCT05742646
Last Updated: 2025-07-23
Results Overview
Participant retention and feasibility in completing the 4-week study
COMPLETED
NA
24 participants
4-week study period
2025-07-23
Participant Flow
Participants randomized to control or experimental arms were youth only. Parents reported symptom at baseline and weeks 4 and 8 but were not exposed or involved in other study procedures. Only enrolled youth participated in EMA reports, activity tracking, medication reporting, and engaged with the app. Enrollment numbers represent dyads, although parents weren't not exposed to the intervention regardless of randomization.
Participant milestones
| Measure |
MATADORS App Basic Information
MATADORS Control: Youth will have access to the MATADORS app basic information. They will be asked to log into the app daily for one month and they will be asked to report within the app their medications taken.
|
MATADORS App to Include Basic Information and Expanded Educational Features
MATADORS: Youth will have access to the MATADORS app to include basic information and expanded educational features. They will be asked to log into the app daily for one month and they will be asked to report within the app how they are feeling each day and their medications taken.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
Youth
|
12
|
12
|
|
Overall Study
Caregiver
|
0
|
0
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Managing AsThma AnD Obesity Related Symptoms (MATADORS) Feasibility Study
Baseline characteristics by cohort
| Measure |
MATADORS App Basic Information
n=12 Participants
MATADORS Control: Youth will have access to the MATADORS app basic information. They will be asked to log into the app daily for one month and they will be asked to report within the app their medications taken. Only youth, not parents, were randomized to control or experimental arms.
|
MATADORS App to Include Basic Information and Expanded Educational Features
n=12 Participants
MATADORS: Youth will have access to the MATADORS app to include basic information and expanded educational features. They will be asked to log into the app daily for one month and they will be asked to report within the app how they are feeling each day and their medications taken. Only youth, not parents, were randomized to control or experimental arms.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
12 participants
n=107 Participants
|
24 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 4-week study periodPopulation: The number of participants analyzed is less than the number enrolled due to loss of follow-up.
Participant retention and feasibility in completing the 4-week study
Outcome measures
| Measure |
MATADORS App Basic Information
n=10 Participants
MATADORS Control: Youth will have access to the MATADORS app basic information. They will be asked to log into the app daily for one month and they will be asked to report within the app their medications taken.
|
MATADORS App to Include Basic Information and Expanded Educational Features
n=11 Participants
MATADORS: Youth will have access to the MATADORS app to include basic information and expanded educational features. They will be asked to log into the app daily for one month and they will be asked to report within the app how they are feeling each day and their medications taken.
|
|---|---|---|
|
Number of Participants Completing 4-week Study Period
|
10 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: The number of participants analyzed is less than the number enrolled due to loss of follow-up.
Number of participants lost to follow-up
Outcome measures
| Measure |
MATADORS App Basic Information
n=10 Participants
MATADORS Control: Youth will have access to the MATADORS app basic information. They will be asked to log into the app daily for one month and they will be asked to report within the app their medications taken.
|
MATADORS App to Include Basic Information and Expanded Educational Features
n=11 Participants
MATADORS: Youth will have access to the MATADORS app to include basic information and expanded educational features. They will be asked to log into the app daily for one month and they will be asked to report within the app how they are feeling each day and their medications taken.
|
|---|---|---|
|
Loss to Follow-up
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 weeksNumber of participants who self withdrew from the study
Outcome measures
| Measure |
MATADORS App Basic Information
n=12 Participants
MATADORS Control: Youth will have access to the MATADORS app basic information. They will be asked to log into the app daily for one month and they will be asked to report within the app their medications taken.
|
MATADORS App to Include Basic Information and Expanded Educational Features
n=12 Participants
MATADORS: Youth will have access to the MATADORS app to include basic information and expanded educational features. They will be asked to log into the app daily for one month and they will be asked to report within the app how they are feeling each day and their medications taken.
|
|---|---|---|
|
Study Withdrawals
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 8 weeksNumber of completed end of study dyadic interviews
Outcome measures
| Measure |
MATADORS App Basic Information
n=12 Participants
MATADORS Control: Youth will have access to the MATADORS app basic information. They will be asked to log into the app daily for one month and they will be asked to report within the app their medications taken.
|
MATADORS App to Include Basic Information and Expanded Educational Features
n=12 Participants
MATADORS: Youth will have access to the MATADORS app to include basic information and expanded educational features. They will be asked to log into the app daily for one month and they will be asked to report within the app how they are feeling each day and their medications taken.
|
|---|---|---|
|
End of Study Dyadic Interviews
|
7 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Not all participants completed all end of study surveys.
Change in Fatigue (measured by PROMIS Pediatric Fatigue)-Self-report of fatigue symptoms ranging from tiredness to overwhelming exhaustion. Low score indicates a low level of fatigue and a high score may represent extreme or debilitating levels of exhaustion. Scores above 65 suggest severe fatigue, 55-64 suggest moderate fatigue, 50-54 suggest mild fatigue, and scores less than 50 suggest fatigue scores that are within normal limits (with the lower the number representing healthier rates). 50 indicates the population mean with a standard deviation of 10
Outcome measures
| Measure |
MATADORS App Basic Information
n=11 Participants
MATADORS Control: Youth will have access to the MATADORS app basic information. They will be asked to log into the app daily for one month and they will be asked to report within the app their medications taken.
|
MATADORS App to Include Basic Information and Expanded Educational Features
n=12 Participants
MATADORS: Youth will have access to the MATADORS app to include basic information and expanded educational features. They will be asked to log into the app daily for one month and they will be asked to report within the app how they are feeling each day and their medications taken.
|
|---|---|---|
|
Change in Fatigue
Baseline
|
49 T score
Standard Deviation 14.7
|
47.2 T score
Standard Deviation 13.8
|
|
Change in Fatigue
Week 8
|
42.9 T score
Standard Deviation 14.1
|
47.2 T score
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Not all participants completed all survey instruments at each study visit.
Change in Self-Efficacy (measured by Change in Self-Efficacy for Managing Chronic Disease-6 item scale). This is a 6-item instrument reported on an analog scale that highlights one's confidence in managing their chronic disease. Each item ranges from 1 (minimum; not confident at all) to 10 (maximum; extremely confident). Overall total scores range from 6-60. Minimum total score = 6 and maximum total score = 60. The higher the total score indicates the higher or better level of self-efficacy.
Outcome measures
| Measure |
MATADORS App Basic Information
n=11 Participants
MATADORS Control: Youth will have access to the MATADORS app basic information. They will be asked to log into the app daily for one month and they will be asked to report within the app their medications taken.
|
MATADORS App to Include Basic Information and Expanded Educational Features
n=12 Participants
MATADORS: Youth will have access to the MATADORS app to include basic information and expanded educational features. They will be asked to log into the app daily for one month and they will be asked to report within the app how they are feeling each day and their medications taken.
|
|---|---|---|
|
Change in Self-Efficacy
Baseline
|
7.4 units on a scale
Standard Deviation 1.9
|
7.3 units on a scale
Standard Deviation 2.3
|
|
Change in Self-Efficacy
Week 8
|
8 units on a scale
Standard Deviation 1.9
|
7.7 units on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Instrument administered and analyzed based on chronological age and not all study participants completed surveys at study visits. With MATADORS basic, 11 participants completed baseline and only 10 completed WK8; for the app with expanded features only 11 participants completed baseline and only 10 completed WK 8. a single participant assessed at week 8 was not assessed at baseline, resulting in 12 unique participants analyzed overall
Change in asthma control (measured by Asthma Control Test). Scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score \>19 indicates well-controlled asthma.
Outcome measures
| Measure |
MATADORS App Basic Information
n=11 Participants
MATADORS Control: Youth will have access to the MATADORS app basic information. They will be asked to log into the app daily for one month and they will be asked to report within the app their medications taken.
|
MATADORS App to Include Basic Information and Expanded Educational Features
n=12 Participants
MATADORS: Youth will have access to the MATADORS app to include basic information and expanded educational features. They will be asked to log into the app daily for one month and they will be asked to report within the app how they are feeling each day and their medications taken.
|
|---|---|---|
|
Change in Asthma Control
Baseline 11-12 years old
|
20.8 score on a scale
Standard Deviation 4.4
|
20.2 score on a scale
Standard Deviation 5.3
|
|
Change in Asthma Control
Baseline 13-17 years old
|
19.2 score on a scale
Standard Deviation 5.1
|
16.2 score on a scale
Standard Deviation 4.6
|
|
Change in Asthma Control
Week 8 11-12 years old
|
19.6 score on a scale
Standard Deviation 5.4
|
20.8 score on a scale
Standard Deviation 2.8
|
|
Change in Asthma Control
Week 8 13-17 years old
|
20.6 score on a scale
Standard Deviation 2.3
|
17.0 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Weekly for 6 weeks (weeks 1-6)Population: Activity level based on Fitbit data weeks 1-4
Number of minutes active per day
Outcome measures
| Measure |
MATADORS App Basic Information
n=11 Participants
MATADORS Control: Youth will have access to the MATADORS app basic information. They will be asked to log into the app daily for one month and they will be asked to report within the app their medications taken.
|
MATADORS App to Include Basic Information and Expanded Educational Features
n=12 Participants
MATADORS: Youth will have access to the MATADORS app to include basic information and expanded educational features. They will be asked to log into the app daily for one month and they will be asked to report within the app how they are feeling each day and their medications taken.
|
|---|---|---|
|
Physical Activity Patterns
Week 1 Very Active
|
10.8 minutes per day
Standard Deviation 14.6
|
10.4 minutes per day
Standard Deviation 11.2
|
|
Physical Activity Patterns
Week 2 Very Active
|
12.7 minutes per day
Standard Deviation 22.0
|
9.3 minutes per day
Standard Deviation 10.0
|
|
Physical Activity Patterns
Week 3 Very Active
|
9.5 minutes per day
Standard Deviation 15.1
|
14.6 minutes per day
Standard Deviation 15.1
|
|
Physical Activity Patterns
Week 4 Very Active
|
14.1 minutes per day
Standard Deviation 19.9
|
14.0 minutes per day
Standard Deviation 14.9
|
SECONDARY outcome
Timeframe: Daily for 28 daysPopulation: Outcome data not collected via app as intended due to technological challenges/
Self-report of rescue and/or controller medication usage
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Daily for 28 daysPopulation: One control participant did not enter any daily symptom reports.
Number of days reporting symptoms of fatigue, pain, anxiety, depression
Outcome measures
| Measure |
MATADORS App Basic Information
n=11 Participants
MATADORS Control: Youth will have access to the MATADORS app basic information. They will be asked to log into the app daily for one month and they will be asked to report within the app their medications taken.
|
MATADORS App to Include Basic Information and Expanded Educational Features
n=12 Participants
MATADORS: Youth will have access to the MATADORS app to include basic information and expanded educational features. They will be asked to log into the app daily for one month and they will be asked to report within the app how they are feeling each day and their medications taken.
|
|---|---|---|
|
Symptom Reporting
|
158 Days (cumulative number of days)
|
183 Days (cumulative number of days)
|
SECONDARY outcome
Timeframe: Baseline, week 4, and week 8Population: Data not collected via app due to technological uses
Self-report of the number of days where the participant missed school, work, or activities
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Daily for 28 daysPopulation: Daily steps
Number of steps taken per day based reported through activity tracker
Outcome measures
| Measure |
MATADORS App Basic Information
n=11 Participants
MATADORS Control: Youth will have access to the MATADORS app basic information. They will be asked to log into the app daily for one month and they will be asked to report within the app their medications taken.
|
MATADORS App to Include Basic Information and Expanded Educational Features
n=12 Participants
MATADORS: Youth will have access to the MATADORS app to include basic information and expanded educational features. They will be asked to log into the app daily for one month and they will be asked to report within the app how they are feeling each day and their medications taken.
|
|---|---|---|
|
Activity Tracker-step Count
Week 3
|
3683 Steps per Day
Standard Deviation 3117
|
7294 Steps per Day
Standard Deviation 3287
|
|
Activity Tracker-step Count
Week 1
|
3943 Steps per Day
Standard Deviation 2705
|
5456 Steps per Day
Standard Deviation 3343
|
|
Activity Tracker-step Count
Week 2
|
4258 Steps per Day
Standard Deviation 2941
|
5503 Steps per Day
Standard Deviation 3317
|
|
Activity Tracker-step Count
Week 4
|
5025 Steps per Day
Standard Deviation 2884
|
6754 Steps per Day
Standard Deviation 3548
|
SECONDARY outcome
Timeframe: Weekly for 4 weeksPopulation: Daily minutes of sleep times four weeks
Number of minutes of sleep per day as reported through activity tracker
Outcome measures
| Measure |
MATADORS App Basic Information
n=10 Participants
MATADORS Control: Youth will have access to the MATADORS app basic information. They will be asked to log into the app daily for one month and they will be asked to report within the app their medications taken.
|
MATADORS App to Include Basic Information and Expanded Educational Features
n=12 Participants
MATADORS: Youth will have access to the MATADORS app to include basic information and expanded educational features. They will be asked to log into the app daily for one month and they will be asked to report within the app how they are feeling each day and their medications taken.
|
|---|---|---|
|
Sleep Patterns
Week 1
|
410 minutes per day
Standard Deviation 103
|
412 minutes per day
Standard Deviation 124
|
|
Sleep Patterns
Week 2
|
417 minutes per day
Standard Deviation 95
|
470 minutes per day
Standard Deviation 81
|
|
Sleep Patterns
Week 3
|
329 minutes per day
Standard Deviation 151
|
436 minutes per day
Standard Deviation 59
|
|
Sleep Patterns
Week 4
|
346 minutes per day
Standard Deviation 145
|
483 minutes per day
Standard Deviation 74
|
SECONDARY outcome
Timeframe: Daily for 28 daysPopulation: Data not collected via app due to technological issues.
Self-report on inability to concentrate
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, week 4, and week 8Population: Average score 1 (low confidence) to 5 (high confidence)
The instrument is a 15-item tool that uses a 5-point self-report scale to measure asthma self-efficacy in relation to daily asthma maintenance and an asthma crisis. A rating of 1 = little confidence whereas a rating of 5 = a high confidence level. Responses are averaged across items to indicate an overall score ranging between 1 (low confidence) to 5 (high confidence)
Outcome measures
| Measure |
MATADORS App Basic Information
n=11 Participants
MATADORS Control: Youth will have access to the MATADORS app basic information. They will be asked to log into the app daily for one month and they will be asked to report within the app their medications taken.
|
MATADORS App to Include Basic Information and Expanded Educational Features
n=12 Participants
MATADORS: Youth will have access to the MATADORS app to include basic information and expanded educational features. They will be asked to log into the app daily for one month and they will be asked to report within the app how they are feeling each day and their medications taken.
|
|---|---|---|
|
Asthma Belief Survey
Baseline
|
4 score on a scale
Standard Deviation 0.7
|
4.1 score on a scale
Standard Deviation 0.6
|
|
Asthma Belief Survey
Week 4
|
4 score on a scale
Standard Deviation 1
|
3.6 score on a scale
Standard Deviation 0.9
|
|
Asthma Belief Survey
Week 8
|
3.9 score on a scale
Standard Deviation 0.8
|
4.2 score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: BaselinePopulation: Overall score-A score between 0 and 14 suggests the examinee has low health literacy.
18-item instrument to assess the ability to read and understand common medical terms. The total score range is 0-18. A score between 0 and 14 suggests the examinee has low health literacy.
Outcome measures
| Measure |
MATADORS App Basic Information
n=12 Participants
MATADORS Control: Youth will have access to the MATADORS app basic information. They will be asked to log into the app daily for one month and they will be asked to report within the app their medications taken.
|
MATADORS App to Include Basic Information and Expanded Educational Features
n=12 Participants
MATADORS: Youth will have access to the MATADORS app to include basic information and expanded educational features. They will be asked to log into the app daily for one month and they will be asked to report within the app how they are feeling each day and their medications taken.
|
|---|---|---|
|
Short Assessment of Health Literacy-English
|
14.2 score on a scale
Standard Deviation 2.7
|
14.8 score on a scale
Standard Deviation 1.9
|
Adverse Events
MATADORS App Basic Information
MATADORS App to Include Basic Information and Expanded Educational Features
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Michelle Nichols
Medical University of South Carolina
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place