Back to resultsManaging AsThma AnD Obesity Related Symptoms (MATADORS) Feasibility Study (MATADORS)
Primary Purpose
Asthma in Children, Obesity, Obesity, Adolescent
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MATADORS
MATADORS Control
Sponsored by
About this trial
This is an interventional other trial for Asthma in Children
Eligibility Criteria
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
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
MATADORS app basic information
MATADORS app to include basic information and expanded educational features
Arm Description
Outcomes
Primary Outcome Measures
Number of participants completing 4-week study period
Participant retention and feasibility in completing the 4-week study
Secondary Outcome Measures
Loss to follow-up
Number of participants lost to follow-up
Study withdrawals
Number of participants who self withdrew from the study
End of study dyadic interviews
Number of completed end of study dyadic interviews
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
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.
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.
Physical Activity Patterns
Number of minutes active per day
Medication adherence
Self-report of rescue and/or controller medication usage
Symptom reporting
Number of days reporting symptoms of fatigue, pain, anxiety, depression
Missed school/work/activity
Self-report of the number of days where the participant missed school, work, or activities
Activity tracker-step count
Number of steps taken per day based reported through activity tracker
Sleep patterns
Number of hours of sleep per day as reported through activity tracker
Inability to concentrate
Self-report on inability to concentrate
Daytime sleepiness
Self-report of daytime sleepiness
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)
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.
Full Information
NCT ID
NCT05742646
First Posted
January 11, 2023
Last Updated
February 14, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Institute of Nursing Research (NINR), National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT05742646
Brief Title
Managing AsThma AnD Obesity Related Symptoms (MATADORS) Feasibility Study
Acronym
MATADORS
Official Title
Managing AsThma AnD Obesity Related Symptoms (MATADORS) Feasibility Study: An mHealth Intervention to Facilitate Symptom Self-management Among Youth
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 12, 2022 (Actual)
Primary Completion Date
April 29, 2022 (Actual)
Study Completion Date
April 29, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute of Nursing Research (NINR), National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children, Obesity, Obesity, Adolescent, Obesity, Childhood
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MATADORS app basic information
Arm Type
Active Comparator
Arm Title
MATADORS app to include basic information and expanded educational features
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
MATADORS
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MATADORS Control
Intervention Description
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 Outcome Measure Information:
Title
Number of participants completing 4-week study period
Description
Participant retention and feasibility in completing the 4-week study
Time Frame
4-week study period
Secondary Outcome Measure Information:
Title
Loss to follow-up
Description
Number of participants lost to follow-up
Time Frame
8 weeks
Title
Study withdrawals
Description
Number of participants who self withdrew from the study
Time Frame
8 weeks
Title
End of study dyadic interviews
Description
Number of completed end of study dyadic interviews
Time Frame
8 weeks
Title
Change in Fatigue
Description
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
Time Frame
8 weeks
Title
Change in Self-Efficacy
Description
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.
Time Frame
8 weeks
Title
Change in Asthma Control
Description
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
Title
Physical Activity Patterns
Description
Number of minutes active per day
Time Frame
Daily for 28 days
Title
Medication adherence
Description
Self-report of rescue and/or controller medication usage
Time Frame
Daily for 28 days
Title
Symptom reporting
Description
Number of days reporting symptoms of fatigue, pain, anxiety, depression
Time Frame
Daily for 28 days
Title
Missed school/work/activity
Description
Self-report of the number of days where the participant missed school, work, or activities
Time Frame
Baseline, week 4, and week 8
Title
Activity tracker-step count
Description
Number of steps taken per day based reported through activity tracker
Time Frame
Daily for 28 days
Title
Sleep patterns
Description
Number of hours of sleep per day as reported through activity tracker
Time Frame
Daily for 28 days
Title
Inability to concentrate
Description
Self-report on inability to concentrate
Time Frame
Daily for 28 days
Title
Daytime sleepiness
Description
Self-report of daytime sleepiness
Time Frame
Daily for 28 days
Title
Asthma Belief Survey
Description
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
Title
Short Assessment of Health Literacy-English
Description
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.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Managing AsThma AnD Obesity Related Symptoms (MATADORS) Feasibility Study
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