Managing AsThma AnD Obesity Related Symptoms (MATADORS) Feasibility Study

Not Applicable

Completed

• Conditions: Asthma in Children; Obesity; Obesity, Childhood; Obesity, Adolescent
• Interventions: Behavioral: MATADORS Control; Behavioral: MATADORS

• 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

Not available

Study Timeline

• Study Start: 2022-01-12
• Primary Completion: 2022-04-29
• Study Completion: 2022-04-29
• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-24
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-08

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

Arm && Interventions

Group	Intervention	Description
MATADORS app basic information	MATADORS Control	-
MATADORS app to include basic information and expanded educational features	MATADORS	-

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
End of study dyadic interviews	8 weeks	Number of completed end of study dyadic interviews
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 (not confident at all) to 10 (extremely confident). The higher the total score indicates the higher the 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.
Daytime sleepiness	Daily for 28 days	Self-report of daytime sleepiness
Loss to follow-up	8 weeks	Number of participants lost to follow-up
Sleep patterns	Daily for 28 days	Number of hours of sleep per day as reported through activity tracker
Inability to concentrate	Daily for 28 days	Self-report on inability to concentrate
Short Assessment of Health Literacy-English	Baseline	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.
Study withdrawals	8 weeks	Number of participants who self withdrew from the study
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
Physical Activity Patterns	Daily for 28 days	Number of minutes active per day
Symptom reporting	Daily for 28 days	Number of days reporting symptoms of fatigue, pain, anxiety, depression
Activity tracker-step count	Daily for 28 days	Number of steps taken per day based reported through activity tracker
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)
Medication adherence	Daily for 28 days	Self-report of rescue and/or controller medication usage
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

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States