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
- 2
- 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
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)
- 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)
- Asthma Belief Survey(Baseline, week 4, and week 8)
- Short Assessment of Health Literacy-English(Baseline)