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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
24
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.
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.
Medical University of South Carolina
Charleston, South Carolina, United States
Number of Participants Completing 4-week Study Period
Participant retention and feasibility in completing the 4-week study
Time frame: 4-week study period
Loss to Follow-up
Number of participants lost to follow-up
Time frame: 8 weeks
Study Withdrawals
Number of participants who self withdrew from the study
Time frame: 8 weeks
End of Study Dyadic Interviews
Number of completed end of study dyadic interviews
Time frame: 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. 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
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
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
Physical Activity Patterns
Number of minutes active per day
Time frame: Weekly for 6 weeks (weeks 1-6)
Medication Adherence
Self-report of rescue and/or controller medication usage
Time frame: Daily for 28 days
Symptom Reporting
Number of days reporting symptoms of fatigue, pain, anxiety, depression
Time frame: Daily for 28 days
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
Activity Tracker-step Count
Number of steps taken per day based reported through activity tracker
Time frame: Daily for 28 days
Sleep Patterns
Number of minutes of sleep per day as reported through activity tracker
Time frame: Weekly for 4 weeks
Inability to Concentrate
Self-report on inability to concentrate
Time frame: 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)
Time frame: 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. The total score range is 0-18. A score between 0 and 14 suggests the examinee has low health literacy.
Time frame: Baseline
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