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Completed

NCT Number: NCT05742646

Managing AsThma AnD Obesity Related Symptoms (MATADORS) Feasibility Study

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.

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Key information

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MATADORS

Behavioral

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.

MATADORS Control

Behavioral

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.

Primary outcomes

  1. Number of Participants Completing 4-week Study Period

    Time frame: 4-week study period

    Participant retention and feasibility in completing the 4-week study

Secondary outcomes

  1. Loss to Follow-up

    Time frame: 8 weeks

    Number of participants lost to follow-up

  2. Study Withdrawals

    Time frame: 8 weeks

    Number of participants who self withdrew from the study

  3. End of Study Dyadic Interviews

    Time frame: 8 weeks

    Number of completed end of study dyadic interviews

  4. Change in Fatigue

    Time frame: 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

  5. Change in Self-Efficacy

    Time frame: 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.

  6. Change in Asthma Control

    Time frame: 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.

  7. Physical Activity Patterns

    Time frame: Weekly for 6 weeks (weeks 1-6)

    Number of minutes active per day

  8. Medication Adherence

    Time frame: Daily for 28 days

    Self-report of rescue and/or controller medication usage

  9. Symptom Reporting

    Time frame: Daily for 28 days

    Number of days reporting symptoms of fatigue, pain, anxiety, depression

  10. Missed School/Work/Activity

    Time frame: Baseline, week 4, and week 8

    Self-report of the number of days where the participant missed school, work, or activities

  11. Activity Tracker-step Count

    Time frame: Daily for 28 days

    Number of steps taken per day based reported through activity tracker

  12. Sleep Patterns

    Time frame: Weekly for 4 weeks

    Number of minutes of sleep per day as reported through activity tracker

  13. Inability to Concentrate

    Time frame: Daily for 28 days

    Self-report on inability to concentrate

  14. Asthma Belief Survey

    Time frame: 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)

  15. Short Assessment of Health Literacy-English

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute of Nursing Research (NINR)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Acronym: MATADORS

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 24, 2023
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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