Managing AsThma AnD Obesity Related Symptoms (MATADORS) Feasibility Study

Not Applicable

Completed

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

Registration Number: NCT05742646

Lead Sponsor: Medical University of South Carolina

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 24

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants Completing 4-week Study Period	4-week study period	Participant retention and feasibility in completing the 4-week study

Secondary Outcome Measures

Name	Time	Method
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
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
Symptom Reporting	Daily for 28 days	Number of days reporting symptoms of fatigue, pain, anxiety, depression
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.

Trial Locations

Locations (1): Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States