Health and Wellness After Preterm Birth: Randomized Controlled Trial of Enhanced Support After Preterm Birth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Acceptability of the CCAPB intervention
研究概览
简要总结
This study continues an adaptation of the behavioral intervention Care Coordination After Preterm Birth (CCAPB). This is a pragmatic pilot randomized controlled feasibility trial of CCAPB with baseline and post-intervention assessments.
详细描述
Interventionists will be trained in care coordination strategies and Motivational Interviewing (MI) techniques. Following training, investigators will enroll eligible women from a postpartum unit at a single hospital, or within 4 weeks of birth.The primary outcome of this study is acceptability and feasibility of the intervention and study procedures as measured by the Acceptability of Intervention Measure, participant completion of study data collection, and interventionist completion of planned intervention modules.
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
- None
入排标准
- 年龄范围
- 14 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 14 - 45
- •History of preterm birth (< 34 weeks gestational age or 34 - 36 weeks with identifiable risk factors for recurrent preterm birth which may including: low preventive care utilization, tobacco use, obesity, depression or anxiety, history of unmet contraceptive needs, chronic or pregnancy-associated hypertension or diabetes. )
- •Intention to seek pediatric care at one of two pediatric primary care sites
- •Medicaid insurance
排除标准
- •History of sterilization procedure.
- •Plan to move away from the area or transfer pediatric primary care within six months of enrollment.
- •Limited English proficiency.
- •History of organ failure or malignancies.
结局指标
主要结局
Acceptability of the CCAPB intervention
时间窗: up to 6 months
Investigators will use the Acceptability of Intervention Measure (modified) with a threshold of \> 3 indicating acceptability.
次要结局
- Contraceptive Use(up to 6 months)
- Depression symptoms(up to 6 months)
- Sleep-related impairment(up to 6 months)
- Tobacco use(up to 1 month)
- Autonomy Support(up to 6 months)
- Patient reported stress.(up to 6 months)
- Autonomous motivation(up to 6 months)
- Completion of recommended postpartum care(up to 6 months)
- Multivitamin use(up to 6 months)