Néevo®/NéevoDHA® P.L.U.S. Program (Progress Through Learning, Understand & Support)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Pamlab, Inc.
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- To determine the safety and tolerability of Néevo®/NéevoDHA® as measured by side effects and compliance
研究概览
简要总结
This is an observational study in which patients who have been prescribed Néevo®/NéevoDHA® are invited to participate in surveys about their pregnancy and experiences with Néevo®/NéevoDHA®. The purpose of this study is to increase the understanding of the role of L-methylfolate among patients who are candidates for Néevo®/NéevoDHA®, provide patients with personalized education and support during their pregnancies, and contribute to the overall understanding of the needs and concerns of women facing intermediate- to high-risk pregnancies.
详细描述
Surveys used to conduct this study will be administered via telephone or online by InfoMedics, Inc., a company with a system for developing such patient-physician feedback programs. Participating physicians will ask their patients to participate in the program after Néevo®/NéevoDHA® has been prescribed and provide them with a patient brochure containing an introduction to the program and instructions on how to enroll. Patients interested in participating self-enroll, take a brief survey before starting their Néevo®/NéevoDHA® prescription, and then a follow-up survey 4 weeks after they have started taking Néevo®/NéevoDHA®. As patients complete surveys within the study, their physician will receive individualized feedback reports outlining their patient's treatment experience and progress. Patients will also receive a copy of their own reports, to help encourage them to continue taking Néevo®/NéevoDHA® as directed. Patients will also receive educational materials about diet and nutrition during pregnancy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •New Néevo®/NéevoDHA® Start.
- •Only for women who are pregnant and taking brand name Néevo®/ NéevoDHA® under a physicians care.
排除标准
- •Patients who are not pregnant.
- •If participant indicates that she did not get a prescription for Néevo®/ NéevoDHA®, she will not be able to complete the survey(s).
- •For the follow-up survey, if the participant indicates that she has not been taking Néevo®/NéevoDHA®, she will not be able to complete the survey( (s).
结局指标
主要结局
To determine the safety and tolerability of Néevo®/NéevoDHA® as measured by side effects and compliance
时间窗: Week 4
To collect data from patient surveys on the patient utilization and effectiveness of Néevo®/NéevoDHA® in a "real world" setting.
次要结局
- To determine overall patient satisfaction with Néevo®/NéevoDHA® using a 9-point satisfaction scale(Week 4)