Asthma Link: A Real World Application of School Supervised Asthma Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Retention of Study Participants (Lost to Follow-up)
研究概览
简要总结
The goal of this study is to assess the feasibility of a clinical trial to evaluate the impact and process of deploying school-supervised asthma therapy in a real-world setting for children with poorly controlled asthma (aged 6-17 years).
详细描述
The proposed 4-site pilot cluster randomized controlled trial will assess the feasibility of conducting a clinical trial of Asthma Link, a real-world school-supervised asthma therapy program. We will compare the impact of Asthma Link deployed in 2 pediatric practice sites versus Enhanced usual care deployed in 2 comparator sites, with 18 parent-child dyads enrolled per site (N=72 dyads).
Primary trial outcomes will be participant recruitment, retention, and intervention fidelity. Secondary trial outcomes will be differences in the frequency of asthma symptoms, emergency department visits, hospital admissions, courses of oral corticosteroids, spirometry values, medication adherence and school absences between intervention and enhanced usual care sites at 3, 6 and 12 month follow up. Additionally we will assess process outcomes (acceptability, adoption, costs, sustainability).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •STUDY INCLUSION/
排除标准
- •Child Inclusion Criteria:
- •Meet the eligibility criteria for Asthma Link (as described below)
- •Enrolled in Asthma Link (if randomized to the Asthma Link Condition)
- •Able and willing to provide informed assent
- •Child Exclusion Criteria:
- •Unable or unwilling to provide informed assent
- •Diagnosis of a serious co-morbid illness during the past 5 years
- •Developmental delay that would prevent study participation.
- •Planning on moving from primary residence or moving outside of the school district in the next 1 year
- •A sibling to a child participating in this study
- •Parent Inclusion Criteria:
- •Parent/guardian to patient
- •18 years or older
- •Able to understand and communicate in English or Spanish
- •Able and willing to provide informed consent.
- •Parent Exclusion Criteria:
- •Adults lacking capacity
- •Prisoners
- •Medical Provider, School Nurse, Asthma Champion Inclusion Criteria:
- •Able and willing to provide informed consent
- •Medical Provider, School Nurse, Asthma Champion Exclusion Criteria:
- •Unable or unwilling to provide informed consent
- •Child eligibility for children enrolled in Asthma Link:
- •children aged 6-17 years (enrolled in grade 1-12)
- •prescribed daily inhaled corticosteroid (ICS) for asthma
- •1 or more courses of oral steroids in the past 2 years OR 1 or more hospitalizations or ED visits for asthma in the past 2 years OR 1 or more sick visits for asthma in the past year OR Asthma Control Test (ACT) score <19
- •parent/child report of poor ICS adherence on adherence checklist- i.e. child or parent says "Yes" when provider asks if they have difficulty remembering to take their medication or if they regularly take medication holidays or breaks
- •able and willing to assent
- •parental permission
- •English or Spanish speaking
结局指标
主要结局
Retention of Study Participants (Lost to Follow-up)
时间窗: Up to end of study, approximately 12 months
Research staff to track number of participants lost to follow-up, who did not complete the 12 month study assessment.
Intervention Fidelity - Pediatric Practice
时间窗: Baseline
Research staff to assess for intervention fidelity within the pediatric practice through a checklist for pediatric staff to assess percentage of eligible children enrolled.
Intervention Fidelity - Percentage of Enrolled Students Receiving Intervention
时间窗: Up to end of study, approximately 12 months
Research staff to assess for intervention fidelity by school nurse report of percentage of enrolled students receiving supervised therapy.
Recruitment Procedures Assessed by Number of Patients Screened
时间窗: Baseline
Research staff will track number of patients screened during enrollment process.
Recruitment Procedures Assessed by Number of Patients Recruited Into the Study
时间窗: Baseline
Research staff will track number of patients recruited into the study after they are assessed for eligibility.
Retention of Study Participants (Drop Out)
时间窗: Up to end of study, approximately 12 months
Research staff to track number of participants who drop out of the study and note reasons for not completing study.
Recruitment Procedures Assessed by Number of Eligible Participants
时间窗: Baseline
Research staff will track number of eligible participants who meeting study criteria during the enrollment process.
Recruitment Procedures Assessed by Number of Eligible Patients That Were Not Enrolled or Refused to Participate.
时间窗: Baseline
Research staff will track the number of patients that were not enrolled or refused to participate in the study along with the reasons for non-enrollment.
Intervention Fidelity - School Nurse and Family Participation
时间窗: Up to end of study, approximately 12 months
Research staff to assess for intervention fidelity by school nurse checklist of each enrolled child attending daily school nurse sessions and his/her family bringing medication to school.
次要结局
- Acceptability - Participants(3 months, 6 months, 12 months)
- Adoption of Asthma Link Intervention - School Nurse(Baseline, 3 months, 6 months, 12 months)
- Sustainability of Intervention(3 months, 6 months, 12 months)
- Adoption of Asthma Link Intervention - Participant(3 months, 6 months, 12 months)
- Frequency of Healthcare Utilization Over Time(Baseline, 3 months, 6 months, 12 months)
- School Absences(Baseline, 3 months, 6 months, 12 months)
- Adoption of Asthma Link Intervention - Medical Provider(Baseline, 3 months, 6 months, 12 months)
- Cost Effectiveness of Intervention(School nurses and pediatric practices 6 and 12 months/Parents 3, 6 and 12 months)
- Asthma Symptoms - Spirometry(Baseline, 3 months, 6 months, 12 months)
- Asthma Symptoms - Asthma Control Test(Baseline, 3 months, 6 months, 12 months)
- Asthma Symptoms - Maximum Symptoms Days(Baseline, 3 months, 6 months, 12 months)
- Medication Adherence(Baseline, 3 months, 6 months, 12 months)
研究者
Michelle Trivedi
Assistant Professor
University of Massachusetts, Worcester