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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

4-week study period

Results posted on

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

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

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 period

Population: 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

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 weeks

Population: 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

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 weeks

Number of participants who self withdrew from the study

Outcome measures

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 weeks

Number of completed end of study dyadic interviews

Outcome measures

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 weeks

Population: 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

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 weeks

Population: 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

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 weeks

Population: 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

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

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 days

Population: 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 days

Population: One control participant did not enter any daily symptom reports.

Number of days reporting symptoms of fatigue, pain, anxiety, depression

Outcome measures

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 8

Population: 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 days

Population: Daily steps

Number of steps taken per day based reported through activity tracker

Outcome measures

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 weeks

Population: Daily minutes of sleep times four weeks

Number of minutes of sleep per day as reported through activity tracker

Outcome measures

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 days

Population: 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 8

Population: 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

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: Baseline

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

MATADORS App to Include Basic Information and Expanded Educational Features

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

Dr. Michelle Nichols

Medical University of South Carolina

Phone: 8437928515

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place