Randomized Controlled Trial of Problem Solving Intervention to Enhance Treatment Adherence in Pediatric Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Adherence to medical treatment, based on electronic monitors
研究概览
简要总结
The purpose of this study is to determine the effectiveness of a tailored problem solving intervention in increasing adherence to asthma management behaviors in African American adolescents with asthma.
详细描述
BACKGROUND:
Children and adolescents who are unable to adhere to their medical regimen for the management of chronic illness present considerable challenges to health care providers and researchers. Pediatric asthma is a chronic illness where the consequences of non-adherence are particularly detrimental and widespread, especially among economically disadvantaged minority children and their families. Studies of intervention of asthma management are needed for this population.
DESIGN NARRATIVE:
The aim of the proposed study is to test the efficacy of a problem solving intervention that is tailored to the observed adherence behaviors and identified barriers to increasing adherence in African American children and adolescents with asthma, and their families. Patients are randomized to either a Tailored Problem Solving Intervention, or a control group who will receive Family Education Intervention. Duration of the intervention is four months.
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
- Single (Investigator)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •African American
- •Family income to be below the poverty line
- •Physician-based diagnosis of asthma of at least 12 months
- •Moderate to severe asthma (moderate asthma includes daily symptoms, daily use of inhaled short acting beta-agonist, exacerbations greater than 2 times per week that affect activity, and nighttime symptoms greater than once a week, FEV1 or Peak Flow PEF between 60 and 80 percent predicted and PEF variability greater than 30 percent; severe asthma includes continual symptoms, limited physical activity, frequent exacerbations together with frequent nighttime symptoms, FEV1 or PEF less than 60 percent predicted, and PEF variability greater than 30 percent)
- •Likely to be on a stable and daily medication (inhaled steroid) that can be modified electronically for the time period required to participate in the study
排除标准
- •Presence of a serious comorbid chronic condition
研究组 & 干预措施
Experimental: Tailored Problem Solving Intervention
Participants will be randomized to follow a tailored problem solving intervention for the child.
干预措施: Family Education Intervention (Behavioral)
Experimental: Tailored Problem Solving Intervention
Participants will be randomized to follow a tailored problem solving intervention for the child.
干预措施: Tailored Problem Solving Intervention (Behavioral)
Control: Family Education Intervention
Participants will be randomized to follow a family education intervention.
干预措施: Tailored Problem Solving Intervention (Behavioral)
Control: Family Education Intervention
Participants will be randomized to follow a family education intervention.
干预措施: Family Education Intervention (Behavioral)
结局指标
主要结局
Adherence to medical treatment, based on electronic monitors
时间窗: 3, 6, 9 and 12 months
describe the trajectories of adherence to daily inhaled corticosteroid (ICS) medication for a year in economically disadvantaged, African-American youth with asthma based on growth curve modeling
次要结局
- Asthma-related morbidity, including symptoms, pulmonary functioning, and health-related quality of life(3, 6, 9 and 12 months)