Asthma in Children, Obesity, Obesity, Adolescent, Obesity, Childhood
Conditions
Brief summary
The purpose of this 4 week pilot study is to test the use of a mobile application (also commonly referred to as an app) designed to help increase self-management strategies among youth that have asthma and obesity. The data obtained from this study will facilitate refinement of the app and interventional approaches for a future larger scale study to increase youth self-management of their clinical conditions, symptom management, and health maintenance as they transition to adulthood.
Detailed description
Investigate the feasibility of a 4-week evidence-based, nurse-guided, mHealth self-management intervention application for youth with asthma and obesity (ages 10-17). Aims are to conduct feasibility testing of the app with a sample of youth randomized to the intervention or control and to obtain estimates of variability and describe preliminary outcomes of the application on fatigue, pain, self-efficacy, anxiety, sleep, depression, and quality of life measured at baseline, 4, and 8 weeks.
Interventions
BEHAVIORALMATADORS
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.
BEHAVIORALMATADORS 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.
Sponsors
National Institute of Nursing Research (NINR)
National Institutes of Health (NIH)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Youth-Caregiver Dyad Inclusion Criteria: * Male and female youth aged 10 - 17 years * Adult primary caregiver (18 years and older) * English speaking * Youth diagnosis of asthma * Prescribed inhaler treatment for asthma * Youth Body Mass Index at or above the 85th percentile for age and sex based on the Centers for Disease Control (CDC) growth charts * Must own a smartphone (iOS) with working Wi-Fi access and/or cellular data plan * Prescribed inhaler treatment for asthma
Exclusion criteria
* Diagnosis of cognitive impairment * Inability or unwillingness of youth participant to assent and/or primary caregiver/legal guardian/representative to give informed consent * Inability or unwillingness to participate in the audio recording interview session or complete study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Completing 4-week Study Period | 4-week study period | Participant retention and feasibility in completing the 4-week study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Study Withdrawals | 8 weeks | Number of participants who self withdrew from the study |
| End of Study Dyadic Interviews | 8 weeks | Number of completed end of study dyadic interviews |
| Change in Fatigue | 8 weeks | 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 |
| Change in Self-Efficacy | 8 weeks | 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. |
| Change in Asthma Control | 8 weeks | 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. |
| Physical Activity Patterns | Weekly for 6 weeks (weeks 1-6) | Number of minutes active per day |
| Medication Adherence | Daily for 28 days | Self-report of rescue and/or controller medication usage |
| Loss to Follow-up | 8 weeks | Number of participants lost to follow-up |
| Missed School/Work/Activity | Baseline, week 4, and week 8 | Self-report of the number of days where the participant missed school, work, or activities |
| Activity Tracker-step Count | Daily for 28 days | Number of steps taken per day based reported through activity tracker |
| Sleep Patterns | Weekly for 4 weeks | Number of minutes of sleep per day as reported through activity tracker |
| Inability to Concentrate | Daily for 28 days | Self-report on inability to concentrate |
| Asthma Belief Survey | Baseline, week 4, and week 8 | 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) |
| Short Assessment of Health Literacy-English | Baseline | 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. |
| Symptom Reporting | Daily for 28 days | Number of days reporting symptoms of fatigue, pain, anxiety, depression |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. Only youth, not parents, were randomized to control or experimental arms. | 12 |
| 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. Only youth, not parents, were randomized to control or experimental arms. | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | MATADORS App Basic Information | MATADORS App to Include Basic Information and Expanded Educational Features | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 12 Participants | 12 Participants | 24 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 12 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 9 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 3 Participants | 7 Participants |
| Region of Enrollment United States | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 14 Participants |
| Sex: Female, Male Male | 7 Participants | 3 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Number of Participants Completing 4-week Study Period
Participant retention and feasibility in completing the 4-week study
Time frame: 4-week study period
Population: The number of participants analyzed is less than the number enrolled due to loss of follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MATADORS App Basic Information | Number of Participants Completing 4-week Study Period | 10 Participants |
| MATADORS App to Include Basic Information and Expanded Educational Features | Number of Participants Completing 4-week Study Period | 11 Participants |
Secondary
Activity Tracker-step Count
Number of steps taken per day based reported through activity tracker
Time frame: Daily for 28 days
Population: Daily steps
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MATADORS App Basic Information | Activity Tracker-step Count | Week 1 | 3943 Steps per Day | Standard Deviation 2705 |
| MATADORS App Basic Information | Activity Tracker-step Count | Week 2 | 4258 Steps per Day | Standard Deviation 2941 |
| MATADORS App Basic Information | Activity Tracker-step Count | Week 3 | 3683 Steps per Day | Standard Deviation 3117 |
| MATADORS App Basic Information | Activity Tracker-step Count | Week 4 | 5025 Steps per Day | Standard Deviation 2884 |
| MATADORS App to Include Basic Information and Expanded Educational Features | Activity Tracker-step Count | Week 4 | 6754 Steps per Day | Standard Deviation 3548 |
| MATADORS App to Include Basic Information and Expanded Educational Features | Activity Tracker-step Count | Week 1 | 5456 Steps per Day | Standard Deviation 3343 |
| MATADORS App to Include Basic Information and Expanded Educational Features | Activity Tracker-step Count | Week 3 | 7294 Steps per Day | Standard Deviation 3287 |
| MATADORS App to Include Basic Information and Expanded Educational Features | Activity Tracker-step Count | Week 2 | 5503 Steps per Day | Standard Deviation 3317 |
Secondary
Asthma Belief Survey
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)
Time frame: Baseline, week 4, and week 8
Population: Average score 1 (low confidence) to 5 (high confidence)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MATADORS App Basic Information | Asthma Belief Survey | Week 4 | 4 score on a scale | Standard Deviation 1 |
| MATADORS App Basic Information | Asthma Belief Survey | Baseline | 4 score on a scale | Standard Deviation 0.7 |
| MATADORS App Basic Information | Asthma Belief Survey | Week 8 | 3.9 score on a scale | Standard Deviation 0.8 |
| MATADORS App to Include Basic Information and Expanded Educational Features | Asthma Belief Survey | Baseline | 4.1 score on a scale | Standard Deviation 0.6 |
| MATADORS App to Include Basic Information and Expanded Educational Features | Asthma Belief Survey | Week 4 | 3.6 score on a scale | Standard Deviation 0.9 |
| MATADORS App to Include Basic Information and Expanded Educational Features | Asthma Belief Survey | Week 8 | 4.2 score on a scale | Standard Deviation 0.7 |
Secondary
Change in Asthma Control
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MATADORS App Basic Information | Change in Asthma Control | Baseline 11-12 years old | 20.8 score on a scale | Standard Deviation 4.4 |
| MATADORS App Basic Information | Change in Asthma Control | Baseline 13-17 years old | 19.2 score on a scale | Standard Deviation 5.1 |
| MATADORS App Basic Information | Change in Asthma Control | Week 8 11-12 years old | 19.6 score on a scale | Standard Deviation 5.4 |
| MATADORS App Basic Information | Change in Asthma Control | Week 8 13-17 years old | 20.6 score on a scale | Standard Deviation 2.3 |
| MATADORS App to Include Basic Information and Expanded Educational Features | Change in Asthma Control | Week 8 13-17 years old | 17.0 score on a scale | Standard Deviation 0 |
| MATADORS App to Include Basic Information and Expanded Educational Features | Change in Asthma Control | Baseline 11-12 years old | 20.2 score on a scale | Standard Deviation 5.3 |
| MATADORS App to Include Basic Information and Expanded Educational Features | Change in Asthma Control | Week 8 11-12 years old | 20.8 score on a scale | Standard Deviation 2.8 |
| MATADORS App to Include Basic Information and Expanded Educational Features | Change in Asthma Control | Baseline 13-17 years old | 16.2 score on a scale | Standard Deviation 4.6 |
Secondary
Change in Fatigue
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
Time frame: 8 weeks
Population: Not all participants completed all end of study surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MATADORS App Basic Information | Change in Fatigue | Baseline | 49 T score | Standard Deviation 14.7 |
| MATADORS App Basic Information | Change in Fatigue | Week 8 | 42.9 T score | Standard Deviation 14.1 |
| MATADORS App to Include Basic Information and Expanded Educational Features | Change in Fatigue | Baseline | 47.2 T score | Standard Deviation 13.8 |
| MATADORS App to Include Basic Information and Expanded Educational Features | Change in Fatigue | Week 8 | 47.2 T score | Standard Deviation 12 |
Secondary
Change in Self-Efficacy
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.
Time frame: 8 weeks
Population: Not all participants completed all survey instruments at each study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MATADORS App Basic Information | Change in Self-Efficacy | Baseline | 7.4 units on a scale | Standard Deviation 1.9 |
| MATADORS App Basic Information | Change in Self-Efficacy | Week 8 | 8 units on a scale | Standard Deviation 1.9 |
| MATADORS App to Include Basic Information and Expanded Educational Features | Change in Self-Efficacy | Baseline | 7.3 units on a scale | Standard Deviation 2.3 |
| MATADORS App to Include Basic Information and Expanded Educational Features | Change in Self-Efficacy | Week 8 | 7.7 units on a scale | Standard Deviation 2.2 |
Secondary
End of Study Dyadic Interviews
Number of completed end of study dyadic interviews
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MATADORS App Basic Information | End of Study Dyadic Interviews | 7 Participants |
| MATADORS App to Include Basic Information and Expanded Educational Features | End of Study Dyadic Interviews | 11 Participants |
Secondary
Inability to Concentrate
Self-report on inability to concentrate
Time frame: Daily for 28 days
Population: Data not collected via app due to technological issues.
Secondary
Loss to Follow-up
Number of participants lost to follow-up
Time frame: 8 weeks
Population: The number of participants analyzed is less than the number enrolled due to loss of follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MATADORS App Basic Information | Loss to Follow-up | 0 Participants |
| MATADORS App to Include Basic Information and Expanded Educational Features | Loss to Follow-up | 0 Participants |
Secondary
Medication Adherence
Self-report of rescue and/or controller medication usage
Time frame: Daily for 28 days
Population: Outcome data not collected via app as intended due to technological challenges/
Secondary
Missed School/Work/Activity
Self-report of the number of days where the participant missed school, work, or activities
Time frame: Baseline, week 4, and week 8
Population: Data not collected via app due to technological uses
Secondary
Physical Activity Patterns
Number of minutes active per day
Time frame: Weekly for 6 weeks (weeks 1-6)
Population: Activity level based on Fitbit data weeks 1-4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MATADORS App Basic Information | Physical Activity Patterns | Week 1 Very Active | 10.8 minutes per day | Standard Deviation 14.6 |
| MATADORS App Basic Information | Physical Activity Patterns | Week 2 Very Active | 12.7 minutes per day | Standard Deviation 22 |
| MATADORS App Basic Information | Physical Activity Patterns | Week 3 Very Active | 9.5 minutes per day | Standard Deviation 15.1 |
| MATADORS App Basic Information | Physical Activity Patterns | Week 4 Very Active | 14.1 minutes per day | Standard Deviation 19.9 |
| MATADORS App to Include Basic Information and Expanded Educational Features | Physical Activity Patterns | Week 4 Very Active | 14.0 minutes per day | Standard Deviation 14.9 |
| MATADORS App to Include Basic Information and Expanded Educational Features | Physical Activity Patterns | Week 1 Very Active | 10.4 minutes per day | Standard Deviation 11.2 |
| MATADORS App to Include Basic Information and Expanded Educational Features | Physical Activity Patterns | Week 3 Very Active | 14.6 minutes per day | Standard Deviation 15.1 |
| MATADORS App to Include Basic Information and Expanded Educational Features | Physical Activity Patterns | Week 2 Very Active | 9.3 minutes per day | Standard Deviation 10 |
Secondary
Short Assessment of Health Literacy-English
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.
Time frame: Baseline
Population: Overall score-A score between 0 and 14 suggests the examinee has low health literacy.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MATADORS App Basic Information | Short Assessment of Health Literacy-English | 14.2 score on a scale | Standard Deviation 2.7 |
| MATADORS App to Include Basic Information and Expanded Educational Features | Short Assessment of Health Literacy-English | 14.8 score on a scale | Standard Deviation 1.9 |
Secondary
Sleep Patterns
Number of minutes of sleep per day as reported through activity tracker
Time frame: Weekly for 4 weeks
Population: Daily minutes of sleep times four weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MATADORS App Basic Information | Sleep Patterns | Week 4 | 346 minutes per day | Standard Deviation 145 |
| MATADORS App Basic Information | Sleep Patterns | Week 1 | 410 minutes per day | Standard Deviation 103 |
| MATADORS App Basic Information | Sleep Patterns | Week 2 | 417 minutes per day | Standard Deviation 95 |
| MATADORS App Basic Information | Sleep Patterns | Week 3 | 329 minutes per day | Standard Deviation 151 |
| MATADORS App to Include Basic Information and Expanded Educational Features | Sleep Patterns | Week 3 | 436 minutes per day | Standard Deviation 59 |
| MATADORS App to Include Basic Information and Expanded Educational Features | Sleep Patterns | Week 4 | 483 minutes per day | Standard Deviation 74 |
| MATADORS App to Include Basic Information and Expanded Educational Features | Sleep Patterns | Week 2 | 470 minutes per day | Standard Deviation 81 |
| MATADORS App to Include Basic Information and Expanded Educational Features | Sleep Patterns | Week 1 | 412 minutes per day | Standard Deviation 124 |
Secondary
Study Withdrawals
Number of participants who self withdrew from the study
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MATADORS App Basic Information | Study Withdrawals | 2 Participants |
| MATADORS App to Include Basic Information and Expanded Educational Features | Study Withdrawals | 1 Participants |
Secondary
Symptom Reporting
Number of days reporting symptoms of fatigue, pain, anxiety, depression
Time frame: Daily for 28 days
Population: One control participant did not enter any daily symptom reports.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MATADORS App Basic Information | Symptom Reporting | 158 Days (cumulative number of days) |
| MATADORS App to Include Basic Information and Expanded Educational Features | Symptom Reporting | 183 Days (cumulative number of days) |