A Pilot Study to Improve Sleep Quality in Urban High School Students With Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Number of subjects successfully completing the interview
研究概览
简要总结
The overall goal of this project is to develop and to preliminarily validate a novel intervention to be delivered in the high school setting that integrates two evidence-based, school-based interventions for urban adolescents with proven efficacy: (1) Asthma Self-Management for Adolescents (ASMA), an intervention for adolescents with uncontrolled asthma and (2) the Sleep-Smart Program (Sleep-Smart), which focuses on sleep hygiene and behaviors in urban adolescents.
The aim for Phase I is to develop and integrate school-based interventions to improve asthma self-management and sleep hygiene in urban high school students via interviews.
The aims for Phase II are: (1) to evaluate the feasibility and acceptability of the intervention procedures; and (2) to assess the preliminary evidence of the effects of the intervention on improving sleep quality in urban high school students with persistent asthma over a 2-month follow-up period.
This record is for Phase I only.
详细描述
Sleep quality among adolescents is poor and asthma's impact is significant among adolescents. Asthma control is an important risk factor for poor sleep and poor academic performance. In addition, poor asthma control, poor sleep hygiene, and poor sleep quality are more likely in urban settings. Interventions to promote sleep quality by targeting both asthma control and sleep hygiene in this vulnerable population are lacking.
To adapt ASMA and Sleep-Smart, the investigators will use a 3-step iterative process that will consist of (1) interviewing high school students and their caregivers, (2) interviewing high school teachers and (3) conducting separate focus groups with students and caregivers. The investigators hypothesize that the intervention will be feasible and acceptable. This study is a multi-site trial and collaboration between Columbia University Medical Center and Rhode Island Hospital (RIH).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •a prior asthma diagnosis in the prior 12 months;
- •use of prescribed asthma medications;
- •persistent asthma (defined as (i) daytime symptoms 3+ days a week, (ii) night awakenings 3+ nights per month, (iii) 2+ Emergency Department visits or (iv) 1+ hospitalization for asthma); and
- •sleep duration < 8 hours
排除标准
- •report of prior diagnosis of a sleep disorder, such as sleep disordered breathing, restless leg syndrome, periodic limb movement syndrome;
- •A Pediatric Sleep Questionnaire (PSQ) score of 0.33 or more, a well-validated measure of sleep disordered breathing risk;
- •active immunotherapy;
- •additional pulmonary disease; and
- •significant developmental delay and/or severe psychiatric or medical conditions that preclude completion of study procedures or confound analyses.
- •SCHOOL TEACHERS (4 high school teachers - 2 from New York and 2 from Rhode Island in Step 2)
- •Inclusion Criteria:
- •Teach at the high school level.
- •Exclusion Criteria:
- •Unwilling to participate in the study.
结局指标
主要结局
Number of subjects successfully completing the interview
时间窗: Up to 10 months
Subjects will be interviewed regarding their preference and opinions about adapted curriculum.
次要结局
未报告次要终点
研究者
Jean-Marie Bruzzese
Professor of Applied Developmental Psychology (in Nursing)
Columbia University