Social Support and Education in Asthma Follow-up (SSEA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 241
- 试验地点
- 1
- 主要终点
- ER visits
研究概览
简要总结
We will evaluate the effect of an eighteen-month asthma coaching intervention for parents/caregivers of children with asthma to reduce asthma morbidity. The primary objective is to determine if asthma coaching will significantly reduce asthma morbidity as measured by a reduction in the number of ED visits and hospitalizations for the children during the 18 months of active coaching and during the 18 months after the coaching stops.
We will provide half of the subjects (parents/caregivers) with access to assistance from an asthma coach for 18 months (including 2 contacts with an asthma nurse during the first 6 months). The other half of the subjects will not have an asthma coach, but their children will have their usual routine care with their primary care providers. The nurse and coach will help the subjects learn more about caring for their children's asthma and improving interactions with the primary care providers for their children.
详细描述
BACKGROUND:
Our previous NHLBI-supported study (HL 57232) showed that a combination treatment of "Coaching" through follow-up phone calls 2 and 5 days following an index ED visit plus monetary incentive was highly effective in increasing the percentage of low-income urban children who received recommended primary care within 2 weeks of the ED visit for asthma, 44% in the intervention group vs 29% in usual care (p = 0.0004). However, the intervention was not associated with significant differences in morbidity (subsequent ED visits). We conclude that the intervention was effective in promoting the initial link to primary care, but was not effective in sustaining that link or management practices to minimize acuity of symptoms during exacerbation.
DESIGN NARRATIVE:
Primary outcome The proportion of children of subjects in each group who have at least one ED visit for acute asthma symptoms during the thirty-six month period following enrollment.
Key secondary outcomes A. The proportion of children of subjects in each group who are hospitalized during the thirty-six month period following enrollment.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A. The child of the parent/caregiver has a diagnosis of asthma made by a physician and reported by the parent, or diagnosis of asthma made during the ED visit if the child has experienced two previous wheezing episodes.
- •B. The child will undergo treatment during the enrollment ED visit for the current asthma exacerbation, as determined by the treating ED clinician. As a result, only parents/caregivers with children experiencing a significant wheezing episode will be entered into the study.
- •C. The child is 2-10 years of age (second birth date until, but not including, eleventh birth date).
- •D. The child has Medicaid or no medical insurance. This criterion permits easy identification and selection of low-income children/families, who are the target population for this proposal.
- •E. The parent/caregiver has a working telephone at home. F. The child attends one of the target practices (7 private practices and 5 federally funded clinics) for routine care.
- •G. The parent/caregiver and child live within the St. Louis metro area.
排除标准
- •A. The child attends a practice other than the target group. B. The parent/caregiver and child live outside of the St. Louis metro area. C. The child has a chronic illness other than asthma that manifests as wheezing or respiratory symptoms.
- •D. The parent/caregiver does not have a working telephone in home. E. The parent/caregiver is not able to effectively communicate in English.
研究组 & 干预措施
Coaching group for lifestyle changes
Patients received monthly phone calls with coaching for lifestyle changes over 2 years.
干预措施: Coaching (Behavioral)
Routine pediatric care
This group receives routine care with their pediatrician.
结局指标
主要结局
ER visits
时间窗: 18 months
Documenting the number of ER visits per patient in the 18 month period.
次要结局
未报告次要终点