upREACH Perinatal Home Visitation Program Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Linkages to Community Resources
研究概览
简要总结
The purpose of this study is to assess the effectiveness of a new brief home visitation program delivered by non-nurse home visitors to 1) improve connections to community resources based on reported and assessed needs, 2) increase health self-efficacy, and 3) reduce maternal stress compared to a control group that receives standard care from an obstetric clinic.
Secondary administrative data on infant birth outcomes, health care use during the first year of life (appointment adherence), and interaction with government services (such as public assistance or child welfare) will be compared between the groups.
For the intervention group, we will secondarily also assess home visit compliance and satisfaction with the intervention.
Participants will be asked to complete questionnaires that include questions about the participant, their pregnancy, their feelings, their family, and their use of social/community services. Half of the women in this study will be randomly offered free home visitation services and the other half of women in this study will receive standard services from the clinic. The intervention group will be offered at least two free home visits with a non-nurse home visitor. During these visits, the home visitor will provide them with resources and tools to help the participant prepare for their baby. All participants will complete a second round of electronic surveys at approximately 2 months postpartum.
Intervention participant outcomes will be compared to a control group that receive standard care from an obstetric clinic.
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)
盲法说明
The analyst will be masked to study allocation.
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant or postpartum women within 3 weeks postpartum (at enrollment)
- •Receiving prenatal or postpartum care from Harris Health Clinic obstetric clinics
- •Speak and read English or Spanish language.
排除标准
- •Unable to speak or read English or Spanish language
- •Women that do not receive perinatal or postpartum care at Harris Health obstetric clinics
- •Women that are not pregnant or greater than 4 weeks postpartum (at enrollment)
结局指标
主要结局
Linkages to Community Resources
时间窗: through study completion, an average of 5 months
Measured by Family Resource Scale (higher score shows that resources are more adequate)
Health Self-Efficacy
时间窗: through study completion, an average of 5 months
Measured by Self-Rated Abilities for Health Practices Scale (higher scores indicate higher health self-efficacy)
Maternal Stress
时间窗: through study completion, an average of 5 months
Perceived Stress Scale (higher scores indicate higher levels of stress)
次要结局
- Trust in Institutions(through study completion, an average of 5 months)
- Appointment Adherence(up to one year postpartum)
研究者
Cary Cain
Assistant Professor
Baylor College of Medicine