Preemie Prep For Parents (P3) Outpatient Mobile Intervention: Home Antenatal Prematurity Education
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 2
- 主要终点
- Parent Prematurity Knowledge Questionnaire
研究概览
简要总结
The Preemie Prep for Parents (P3) mobile intervention will be tested in an outpatient population of pregnant women at risk of preterm birth and their partners. The study is a randomized controlled trial (RCT) comparing knowledge and preparedness for decision making between a group receiving the P3 texts and videos and a group receiving links to American College of Obstetricians and Gynecologists (ACOG) prematurity patient education handouts.
详细描述
This is a randomized controlled study focused on an outpatient population of pregnant women at risk of preterm birth and their partners. The objective is to test the efficacy of the Preemie Prep for Parents (P3) intervention on prematurity knowledge and preparedness for decision making.
Participants are recruited from their obstetric clinic appointment between weeks 16 and 21, and randomized 1:1 to either the P3 intervention, or access to electronic ACOG handouts (active control). Any participating partners are assigned to the same arm as their pregnant partner. The participants in the P3 group will then receive a schedule of automated text messages, with video links, up to twice a day. These videos and messages are based on information relevant to their gestational age.
At study entry, participants will complete measures of their health literacy, anxiety, decision self-efficacy, and subjective global health. As pregnancy continues, questionnaires will be sent to participants at the start of their 25th, 30th, and 34th weeks. These questionnaires will include Prematurity Knowledge Questionnaires (specific to their gestational age), a Preparation for Decision Making scale, and an anxiety measure. At study completion, within two weeks of either preterm childbirth or completion of the 34 week questionnaire, participants will be asked to also complete the Educational-Aid Questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pregnant woman or her partner
- •At risk for preterm birth, as indicated by: history of spontaneous preterm birth (during the 34th week or earlier), shortened cervical length, multiple gestation, fetal growth restriction, chronic hypertension, history of preeclampsia, and/or diabetes requiring medications.
- •Gestational age of 16-21 weeks at recruitment.
- •Owns a smartphone.
- •Able to speak English
排除标准
- •Pregnancies with known significant birth defects.
结局指标
主要结局
Parent Prematurity Knowledge Questionnaire
时间窗: Assessed at participant's 34th week of pregnancy.
Knowledge questionnaire developed by research team and tested through cognitive interviews, testing parental prematurity knowledge recommended by Eunice Kennedy Shriver National Institute of Child Health and Human Development. Subscales consist of long-term outcomes, variability in due date estimation, general prematurity knowledge, lowest gestational age needed for survival, factors influencing preterm birth outcome, treatment options, short-term outcomes, and advocacy. Subscale scores are summed to create a composite score. Versions of the questionnaire are slightly different at follow up points to ensure gestational age specific clinical relevance; the version at 34 weeks the questionnaire has 30 items. Therefore the range of scores is from 0-30, with higher scores indicating greater knowledge.
Preparation for Decision Making Scale
时间窗: Assessed at participant's 34th week of pregnancy.
Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005). Scale ranges from a score of 10 to 50; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators. Higher scores indicate higher perceived level of preparation for discussing a healthcare related decision.
次要结局
- Decision Self-Efficacy(Assessed at 34 weeks of pregnancy)
- Anxiety(Assessed at participant's 34th week of pregnancy.)
研究者
Mir A Basir
Associate Professor
Medical College of Wisconsin