Managing AsThma AnD Obesity Related Symptoms (MATADORS) Feasibility Study

Obesity Clinical Trial

— MATADORS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05742646
• Other study ID #: 00109618
• Secondary ID: 5P20NR016575-04
• Status: Completed
• Phase: N/A
• Start date: January 12, 2022
• Est. completion date: April 29, 2022

Study information

• Verified date: December 2023
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 29, 2022
• Est. primary completion date: April 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children
• Obesity
• Obesity, Adolescent
• Obesity, Childhood
• Pediatric Obesity

Intervention

Behavioral:
• MATADORS
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
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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute of Nursing Research (NINR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants completing 4-week study period	Participant retention and feasibility in completing the 4-week study	4-week study period
Secondary	Loss to follow-up	Number of participants lost to follow-up	8 weeks
Secondary	Study withdrawals	Number of participants who self withdrew from the study	8 weeks
Secondary	End of study dyadic interviews	Number of completed end of study dyadic interviews	8 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Physical Activity Patterns	Number of minutes active per day	Daily for 28 days
Secondary	Medication adherence	Self-report of rescue and/or controller medication usage	Daily for 28 days
Secondary	Symptom reporting	Number of days reporting symptoms of fatigue, pain, anxiety, depression	Daily for 28 days
Secondary	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
Secondary	Activity tracker-step count	Number of steps taken per day based reported through activity tracker	Daily for 28 days
Secondary	Sleep patterns	Number of hours of sleep per day as reported through activity tracker	Daily for 28 days
Secondary	Inability to concentrate	Self-report on inability to concentrate	Daily for 28 days
Secondary	Daytime sleepiness	Self-report of daytime sleepiness	Daily for 28 days
Secondary	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
Secondary	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