Improving Asthma Care Together (IMPACT): A Shared Management Pilot Study for Children With Asthma and Their Parents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Asthma Responsibility Questionnaire Change From Baseline to 8 Weeks
研究概览
简要总结
This study aims to iteratively develop, refine and test the Improving Asthma Care Together (IMPACT) Intervention for school-age children (7-11 years) with persistent asthma and their parents.
详细描述
Asthma is one of the most common chronic conditions of childhood, affecting over six million US children. Asthma treatment relies on self-management including symptom monitoring and response, trigger avoidance, and timely and appropriate medication use. Unfortunately, fewer than 50% of children with asthma are adherent to asthma treatment regimens, leading to increased disease morbidity and mortality and potentially irreversible airway damage.
Children with asthma are missing a voice in their own care. The school-age years (7-11) represent a natural transition in asthma management, as children must assume some responsibility for asthma-related care while they spend increasing time away from parents at school and other extracurricular activities. Yet, existing interventions focus on parents alone and use prescriptive approaches, telling the parent what to "do" to the child to manage their asthma. As a result, current strategies are failing to provide children with asthma and their families the tools they need to manage asthma successfully within the realities of their daily lives.
Using a Human-Centered Design (HCD) framework, the investigators co-designed a tailored asthma shared management mobile health application that pairs the parent and child together as a team and facilitates the intentional transition of some asthma management to the child. The hypothesis is that by involving children in their own care, participants will improve asthma management in the present, but also establish lifelong successful self-management skills. The objective of the proposed study is to pilot test the Improving Asthma Care Together (IMPACT) mobile health application with parent-child dyads. Based on the preliminary data, the central hypothesis is that IMPACT will be effective for delivering a shared asthma management intervention for children and their parents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinician diagnosis of persistent asthma (prescription for daily asthma medication)
- •Speak English
- •PARENT Inclusion Criteria:
- •18 years or older
- •Child's primary caregiver
- •Able to understand and read English
- •Reside with the child 50% or more
- •Legal guardian who can consent for child to participate
- •Have access to a smart phone and reliable home internet access
- •Reported Asthma Responsibility Questionnaire score < or = 2.5 at screening
排除标准
- •Parent report of developmental delay (language < 5 year level)
- •Co-morbid cancer, diabetes, attention deficit hyperactivity disorder (ADHD)
- •Current asthma exacerbation at the time of recruitment
结局指标
主要结局
Asthma Responsibility Questionnaire Change From Baseline to 8 Weeks
时间窗: Baseline and 8 weeks
10- items, 5-point scale to report asthma management task responsibility. Total score is the mean of all items calculated. Scores range from 1 to 5, with 1= parent takes responsibility all of the time, 3= parent and child share responsibility about equally, and 5 = child takes responsibility all of the time.
Asthma Management Self-efficacy Change From Baseline to 8 Weeks
时间窗: Baseline and 8 weeks
13-items (parent) and 12-items (child), 5-point scale assesses asthma self-efficacy. Scores are averaged with higher scores indicate higher self-efficacy. Possible range of 1-5.
Asthma Responsibility Questionnaire Change From 8 to 16 Weeks
时间窗: 8 and 16 weeks
10- items, 5-point scale to report asthma management task responsibility. Total score is the mean of all items calculated. Scores range from 1 to 5, with 1= parent takes responsibility all of the time, 3= parent and child share responsibility about equally, and 5 = child takes responsibility all of the time.
Asthma Management Self-efficacy Change From 8 Weeks to 16 Weeks
时间窗: 8 and 16 weeks
13-items (parent) and 12-items (child), 5-point scale assesses asthma self-efficacy. Scores are averaged and higher scores indicate higher self-efficacy. Possible score range of 1-5.
次要结局
- Spirometry - FEV1/FVC Change From Baseline to 8 Weeks(Baseline and 8 weeks)
- Spirometry - FEV1/FVC Change From 8 Weeks to 16 Weeks(8 and 16 weeks)
- Childhood Asthma Control Test Change From 8 Weeks to 16 Weeks(8 and 16 weeks)
- Childhood Asthma Control Test Change From Baseline to 8 Weeks(Baseline and 8 weeks)
- Acceptability of Intervention Measure (Intervention Groups Only)(8 weeks)
- Childhood Asthma Quality of Life Change From 8 Weeks to 16 Weeks(8 and 16 weeks)
- System Usability Scale (Intervention Group Only)(8 weeks)
- Childhood Asthma Quality of Life Change From Baseline to 8 Weeks(Baseline and 8 weeks)
- Parent Asthma Quality of Life Change From Baseline to 8 Weeks(Baseline and 8 weeks)
- Medication Adherence Change From 8 Weeks to 16 Weeks(8 and 16 weeks)
- Parent Asthma Quality of Life Change From 8 Weeks to 16 Weeks(8 and 16 weeks)
- Medication Adherence Change From Baseline to 8 Weeks(Baseline and 8 weeks)
- Feasibility of Intervention (Intervention Group Only)(8 weeks)
研究者
Jennifer Sonney
Assistant Professor, School of Nursing
University of Washington