Managing AsThma AnD Obesity Related Symptoms (MATADORS) Feasibility Study: An mHealth Intervention to Facilitate Symptom Self-management Among Youth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of Participants Completing 4-week Study Period
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
MATADORS app basic information
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.
干预措施: MATADORS Control (Behavioral)
MATADORS app to include basic information and expanded educational features
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.
干预措施: MATADORS (Behavioral)
结局指标
主要结局
Number of Participants Completing 4-week Study Period
时间窗: 4-week study period
Participant retention and feasibility in completing the 4-week study
次要结局
- Change in Fatigue(8 weeks)
- Change in Self-Efficacy(8 weeks)
- Change in Asthma Control(8 weeks)
- Asthma Belief Survey(Baseline, week 4, and week 8)
- Short Assessment of Health Literacy-English(Baseline)
- Medication Adherence(Daily for 28 days)
- Loss to Follow-up(8 weeks)
- Study Withdrawals(8 weeks)
- End of Study Dyadic Interviews(8 weeks)
- Asthma Belief Survey(Baseline, week 4, and week 8)
- Change in Fatigue(8 weeks)
- Change in Self-Efficacy(8 weeks)
- Change in Asthma Control(8 weeks)
- Physical Activity Patterns(Weekly for 6 weeks (weeks 1-6))
- Symptom Reporting(Daily for 28 days)
- Missed School/Work/Activity(Baseline, week 4, and week 8)
- Activity Tracker-step Count(Daily for 28 days)
- Sleep Patterns(Weekly for 4 weeks)
- Inability to Concentrate(Daily for 28 days)
- Short Assessment of Health Literacy-English(Baseline)