CHOICES for Sickle Cell Reproductive Health: Randomized Clinical Trial (RCT) of a Preconception Intervention Model for a Single Gene Disorder
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 506
- 试验地点
- 1
- 主要终点
- Sickle Cell Reproductive Health Knowledge
研究概览
简要总结
The study will use web-based data collection (SCKnowIQ) and intervention delivery strategies enhanced by nudges and tailored boosters in a sample of 430 adult men and women, aged 18-45 yr with SCD (Sickle Cell Disease) or SCT (Sickle Cell Trait), at-risk, and planning within 2 years to have a child free of SCD.
详细描述
In a 2-year, randomized, longitudinal, repeated measures, controlled trial in 430 at-risk young adults with SCD (50%) or SCT (50%) to compare the effects of e-Book (electronic-Book) and CHOICES interventions on knowledge and behaviors across time (baseline, immediate posttest, 6, 12, 18, 24 months). The study will provide boosters tailored to knowledge deficits at 6 and 12 months and add monthly reinforcement nudges toward concordant behavior during the first 12 months.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of SCD (HbSS, HbSC (Hemoglobin Sickle C Disease), HbS-beta-0 thalassemia, and HbS-beta+ thalassemia) or report of SCT (SCD is Hgb electrophoresis confirmed; SCT evaluated by SickleScan);
- •Able and intends to conceive a child in the next 2 years (first child or another child);
- •Speaks and reads English;
- •18 to 45 years;
- •At-risk for having a child with SCD (i.e., sexual/ reproductive partner has SCD, SCT, or unknown sickle cell status); and
- •Wants to avoid the risk of a child with SCD.
- •The age range is based on typical reproductive age for SCD where median survival is 42 years for men and 48 years for women.
排除标准
- •Legally blind;
- •Physically unable to complete the study questionnaires or the intervention;
- •Report health history of hysterectomy, tubal ligation, medically or surgically induced menopause, or vasectomy that would
- •Prevent ability to bear children;
- •Report a desire to remain childless or have no further children;
- •Report knowing or being a relative or friend of a participant previously enrolled in the study, or
- •Previous participation in a CHOICES study.
结局指标
主要结局
Sickle Cell Reproductive Health Knowledge
时间窗: Baseline up to 24 months
Knowledge. The Sickle Cell Reproductive Health Knowledge Questionnaire measures knowledge of the genetic transmission of SCD and SCT, etiology of SCD, parenting options for people with SCD or SCT, types of contraceptives safe for people with SCD or SCT, and risks of complications during pregnancy for the woman with SCD. Responses are multiple choice options. Scores are totaled across all items, ranging from 0 to 17; higher scores reflect better knowledge than lower scores.
次要结局
未报告次要终点