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| ID | Type | Description | Link |
|---|---|---|---|
| 5P20NR016575-04 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
| National Institutes of Health (NIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MATADORS app basic information | Active Comparator | The basic app includes real-time symptom monitoring through ecological momentary assessment (EMA) and medication adherence. Basic SMS text messages are sent to participants with reminders to complete EMA questions and enter medication taken. Participants also are provided with activity trackers to assess physical activity and sleep patterns. |
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| MATADORS app to include basic information and expanded educational features | Experimental | Participants in the experimental arm have access to the basic app, along with educational and resource-specific information on asthma, obesity, medications, symptom management, and lifestyle modifications. Features include images, text, and video content. Participants in the experimental arm also are provided with activity trackers to assess physical activity and sleep patterns. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Completing 4-week Study Period | Participant retention and feasibility in completing the 4-week study | 4-week study period |
| Measure | Description | Time Frame |
|---|---|---|
| Loss to Follow-up | Number of participants lost to follow-up | 8 weeks |
| Study Withdrawals | Number of participants who self withdrew from the study |
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Inclusion Criteria:
Youth-Caregiver Dyad Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Nichols, PhD, RN | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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Participants randomized to control or experimental arms were youth only. Parents reported symptom at baseline and weeks 4 and 8 but were not exposed or involved in other study procedures. Only enrolled youth participated in EMA reports, activity tracking, medication reporting, and engaged with the app. Enrollment numbers represent dyads, although parents weren't not exposed to the intervention regardless of randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | MATADORS App Basic Information | 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. |
| FG001 | MATADORS App to Include Basic Information and Expanded Educational Features | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline data were not collected for caregivers/parents.
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| ID | Title | Description |
|---|---|---|
| BG000 | MATADORS App Basic Information | 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. Only youth, not parents, were randomized to control or experimental arms. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Completing 4-week Study Period | Participant retention and feasibility in completing the 4-week study | The number of participants analyzed is less than the number enrolled due to loss of follow-up. | Posted | Count of Participants | Participants | 4-week study period |
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4 months
Caregivers were not monitored or assessed for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MATADORS App Basic Information | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michelle Nichols | Medical University of South Carolina | 8437928515 | nicholmg@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 25, 2021 | Apr 30, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 2, 2021 | Nov 27, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 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. |
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| 8 weeks |
| End of Study Dyadic Interviews | Number of completed end of study dyadic interviews | 8 weeks |
| 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. 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 | 8 weeks |
| 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 (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. | 8 weeks |
| 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 |
| Physical Activity Patterns | Number of minutes active per day | Weekly for 6 weeks (weeks 1-6) |
| Medication Adherence | Self-report of rescue and/or controller medication usage | Daily for 28 days |
| Symptom Reporting | Number of days reporting symptoms of fatigue, pain, anxiety, depression | Daily for 28 days |
| 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 |
| Activity Tracker-step Count | Number of steps taken per day based reported through activity tracker | Daily for 28 days |
| Sleep Patterns | Number of minutes of sleep per day as reported through activity tracker | Weekly for 4 weeks |
| Inability to Concentrate | Self-report on inability to concentrate | Daily for 28 days |
| 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 |
| Short Assessment of Health Literacy-English | 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. | Baseline |
| MATADORS App to Include Basic Information and Expanded Educational Features |
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. Only youth, not parents, were randomized to control or experimental arms. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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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.
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| Secondary | Loss to Follow-up | Number of participants lost to follow-up | The number of participants analyzed is less than the number enrolled due to loss of follow-up. | Posted | Count of Participants | Participants | 8 weeks |
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| Secondary | Study Withdrawals | Number of participants who self withdrew from the study | Posted | Count of Participants | Participants | 8 weeks |
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| Secondary | End of Study Dyadic Interviews | Number of completed end of study dyadic interviews | Posted | Count of Participants | Participants | 8 weeks |
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| 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. 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 | Not all participants completed all end of study surveys. | Posted | Mean | Standard Deviation | T score | 8 weeks |
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| 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 (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. | Not all participants completed all survey instruments at each study visit. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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| 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. | Instrument administered and analyzed based on chronological age and not all study participants completed surveys at study visits. With MATADORS basic, 11 participants completed baseline and only 10 completed WK8; for the app with expanded features only 11 participants completed baseline and only 10 completed WK 8. a single participant assessed at week 8 was not assessed at baseline, resulting in 12 unique participants analyzed overall | Posted | Mean | Standard Deviation | score on a scale | 8 weeks |
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| Secondary | Physical Activity Patterns | Number of minutes active per day | Activity level based on Fitbit data weeks 1-4 | Posted | Mean | Standard Deviation | minutes per day | Weekly for 6 weeks (weeks 1-6) |
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| Secondary | Medication Adherence | Self-report of rescue and/or controller medication usage | Outcome data not collected via app as intended due to technological challenges/ | Posted | Daily for 28 days |
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| Secondary | Symptom Reporting | Number of days reporting symptoms of fatigue, pain, anxiety, depression | One control participant did not enter any daily symptom reports. | Posted | Number | Days (cumulative number of days) | Daily for 28 days |
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| Secondary | Missed School/Work/Activity | Self-report of the number of days where the participant missed school, work, or activities | Data not collected via app due to technological uses | Posted | Baseline, week 4, and week 8 |
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| Secondary | Activity Tracker-step Count | Number of steps taken per day based reported through activity tracker | Daily steps | Posted | Mean | Standard Deviation | Steps per Day | Daily for 28 days |
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| Secondary | Sleep Patterns | Number of minutes of sleep per day as reported through activity tracker | Daily minutes of sleep times four weeks | Posted | Mean | Standard Deviation | minutes per day | Weekly for 4 weeks |
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| Secondary | Inability to Concentrate | Self-report on inability to concentrate | Data not collected via app due to technological issues. | Posted | Daily for 28 days |
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| 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) | Average score 1 (low confidence) to 5 (high confidence) | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 4, and week 8 |
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| Secondary | Short Assessment of Health Literacy-English | 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. | Overall score-A score between 0 and 14 suggests the examinee has low health literacy. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | MATADORS App to Include Basic Information and Expanded Educational Features | 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. | 0 | 12 | 0 | 12 | 0 | 12 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Baseline 13-17 years old |
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| Week 8 11-12 years old |
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| Week 8 13-17 years old |
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| Week 2 Very Active |
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| Week 3 Very Active |
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| Week 4 Very Active |
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