The Efficacy of CAMP Air, a Web-based Asthma Intervention, Among Urban Adolescents With Uncontrolled Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 374
- 试验地点
- 1
- 主要终点
- Mean score on the Asthma Control Questionnaire (ACQ-5)
研究概览
简要总结
This study will test the efficacy and cost-effectiveness of Controlling Asthma Program for Adolescents (CAMP Air), an e-health intervention, among urban predominately Black and Hispanic adolescents with uncontrolled asthma. It will also examine barriers and facilitators to adoption and implementation of CAMP Air in high-schools.
详细描述
Asthma prevalence and morbidity are high among adolescents, especially among Black and Hispanic youth. Yet, few interventions have been tested in adolescents. Despite the important role that technology plays in the lives of adolescents, only one intervention for adolescents with asthma is web-based. Additionally, research informing the scale-up of asthma interventions as well as their cost-effectiveness are scant. This study aims to address these treatment and methodological gaps by (1) systematically evaluating the efficacy of Controlling Asthma Program for Adolescents (CAMP Air), an e-health intervention, in urban adolescents with uncontrolled asthma; (2) assessing CAMP Air's cost-effectiveness; and (3) identifying multi-level factors associated with successful implementation of CAMP Air to inform its future scale-up. Due to COVID, at the start of the study, the spirometry data will not be collected from the participants (Secondary Outcomes 7 - 9).
The investigators plan to interview adolescents as the primary respondent for all outcomes.
Caregivers and school personnel are invited to be interviewed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The principal investigator responsible for evaluating the efficacy of the intervention and the research assistants conducting assessment interviews with adolescents and their caregiver will be blind to assigned arm conditions.
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents must report
- •A prior diagnosis of asthma;
- •Asthma medication use in the last 12 months; and
- •Symptoms consistent with uncontrolled asthma, defined as: in the last month (a) daytime symptoms 3+ days a week, (b) night awakenings 3+ nights per month, or (c) activity limitations 3+ days per week; OR in the last 12 months (d) 2+ unscheduled visits to a clinic or medical provider because having asthma symptoms, (e) 2+ ED visits; (f) 1+ hospitalization for asthma, or (g) taken oral or systemic steroids in the past year.
排除标准
- •Pregnant teenagers due to the stress of adolescent pregnancy and hormonal changes of pregnancy that could change asthma control;
- •Students enrolled in 12th grade because those randomized to the control group will not be in the school the following school year to receive CAMP Air;
- •Teenagers with a co-morbid disease or condition that might affect lung function, such as cystic fibrosis or sickle cell anemia; and
- •Teenagers with highly specialized learning needs (e.g., Down's syndrome, mental retardation, severe ADHD) which may preclude completion of the intervention or assessments.
研究组 & 干预措施
Attention Control Asthma Education Intervention
The control intervention consists of 7 online sessions delivered via PowerPoint slides with voice-over. Teens receive information on asthma and other related health conditions, such as stress and sleep, and will be given a list of relevant websites to learn more about these topics. They will learn how to monitor their health using checklists and will be referred to a medical provider for asthma and other conditions; if they do have a medical provider, they will be provided with a referral. The asthma education component for this group lacks the interactive and personalized elements of CAMP Air, differentiating it from the experimental arm.
干预措施: Attention Control Asthma Education Intervention (Behavioral)
CAMP Air
This is an e-health intervention consisting of 7 online modules. This behavioral intervention combines instruction, hands-on learning, interactive practice opportunities and tailored sessions. Teens learn about asthma, including treatment and triggers, the importance of seeing a medical provider and how they can overcome their specific barriers to seeing a medical provider, how they can talk to their parents about their asthma, and how they can care for their asthma, including managing stress and triggers. They also receive personalized feedback throughout the intervention and guidance on navigating the health care system.
干预措施: Controlling Asthma Program for Adolescents (CAMP Air) (Behavioral)
结局指标
主要结局
Mean score on the Asthma Control Questionnaire (ACQ-5)
时间窗: Up to 1 year
This measure, which is completed by the adolescents, assesses the adolescent's level of asthma control over the past week using 5-item version. The overall score is the mean of all questions; range = 0 - 6; lower scores indicate better control.
Total number of asthma-related urgent care visits
时间窗: Up to 1 year
This measure assesses the adolescent's number of asthma-related visits to a medical provider for urgent or immediate treatment, emergency room visits, and hospitalizations over 3 months. Completed by adolescents. Higher counts indicate more urgent health care utilization.
次要结局
- Mean score on the Asthma Symptom Prevention Index(Up to 1 year)
- Mean score on the Asthma Management Index(Up to 1 year)
- Mean score on the Asthma Management Self-efficacy Index(Up to 1 year)
- Frequency of school absences due to asthma(Up to 1 year)
- Total number of school absences(Up to 1 year)
- Lung function - Overall functioning (Absolute ratio)(Up to 1 year)
- Lung Function - Obstruction to airflow (Maximum mid-expiratory flow rate)(Up to 1 year)
- Lung function - Severity of impairment (FEV1% predicted)(Up to 1 year)
- Mean score on the Paediatric Asthma Quality of Life Questionnaire(Up to 1 year)
- Total number of oral steroid bursts(Up to 1 year)
- Total number of days with asthma symptoms(Up to 1 year)
- Total number of nights woken due to asthma(Up to 1 year)
- Total number of days with activity limitations due to asthma(Up to 1 year)
- Total number of school absences due to asthma(Up to 1 year)
- Mean score on the Asthma Symptom Prevention Index(Up to 1 year)
- Mean score on the Asthma Management Index(Up to 1 year)
- Mean score on the Asthma Management Self-efficacy Index(Up to 1 year)
- Proportion of adolescents taking controller medication(Up to 1 year)
- Lung function - Overall functioning (Absolute ratio)(Up to 1 year)
- Lung Function - Obstruction to airflow (Maximum mid-expiratory flow rate)(Up to 1 year)
- Lung function - Severity of impairment (FEV1% predicted)(Up to 1 year)
- Mean score on the Paediatric Asthma Quality of Life Questionnaire(Up to 1 year)
- Total number of oral steroid bursts(Up to 1 year)
- Total number of days with asthma symptoms(Up to 1 year)
- Total number of nights woken due to asthma(Up to 1 year)
- Total number of days with activity limitations due to asthma(Up to 1 year)
- Total number of school absences due to asthma(Up to 1 year)
- Frequency of school absences due to asthma(Up to 1 year)
- Total number of school absences(Up to 1 year)
研究者
Jean-Marie Bruzzese
Professor of Applied Developmental Psychology (in Nursing)
Columbia University