Managing AsThma AnD Obesity Related Symptoms (MATADORS) Feasibility Study

Study Overview
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Brief Summary
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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.

Official Title
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Managing AsThma AnD Obesity Related Symptoms (MATADORS) Feasibility Study: An mHealth Intervention to Facilitate Symptom Self-management Among Youth

Conditions
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Asthma in Children, Obesity, Obesity, Adolescent, Obesity, Childhood

Intervention / Treatment
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* Behavioral: MATADORS
* Behavioral: MATADORS Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MATADORS app basic information<br> | Behavioral: MATADORS Control<br>* 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.<br>|
| Experimental: MATADORS app to include basic information and expanded educational features<br> | Behavioral: MATADORS<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants completing 4-week study period | Participant retention and feasibility in completing the 4-week study | 4-week study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loss to follow-up | Number of participants lost to follow-up | 8 weeks | 
| Study withdrawals | Number of participants who self withdrew from the study | 8 weeks | 
| End of study dyadic interviews | Number of completed end of study dyadic interviews | 8 weeks | 
| 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 | 8 weeks | 
| 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 (not confident at all) to 10 (extremely confident). The higher the total score indicates the higher the level of self-efficacy. | 8 weeks | 
| 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. | 8 weeks | 
| Physical Activity Patterns | Number of minutes active per day | Daily for 28 days | 
| Medication adherence | Self-report of rescue and/or controller medication usage | Daily for 28 days | 
| Symptom reporting | Number of days reporting symptoms of fatigue, pain, anxiety, depression | Daily for 28 days | 
| Missed school/work/activity | Self-report of the number of days where the participant missed school, work, or activities | Baseline, week 4, and week 8 | 
| Activity tracker-step count | Number of steps taken per day based reported through activity tracker | Daily for 28 days | 
| Sleep patterns | Number of hours of sleep per day as reported through activity tracker | Daily for 28 days | 
| Inability to concentrate | Self-report on inability to concentrate | Daily for 28 days | 
| Daytime sleepiness | Self-report of daytime sleepiness | Daily for 28 days | 
| 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) | Baseline, week 4, and week 8 | 
| Short Assessment of Health Literacy-English | 18-item instrument to assess the ability to read and understand common medical terms. A score between 0 and 14 suggests the examinee has low health literacy. | Baseline |