Néevo®/NéevoDHA® P.L.U.S. Program (Progress Through Learning, Understand & Support)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Néevo®/NéevoDHA® P.L.U.S. Program (Progress Through Learning, Understand & Support)|
- To determine the safety and tolerability of Néevo®/NéevoDHA® as measured by side effects and compliance [ Time Frame: Week 4 ] [ Designated as safety issue: No ]To collect data from patient surveys on the patient utilization and effectiveness of Néevo®/NéevoDHA® in a "real world" setting.
- To determine overall patient satisfaction with Néevo®/NéevoDHA® using a 9-point satisfaction scale [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2011|
|Study Completion Date:||March 2012|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Subjects who have been prescribed Néevo/NéevoDHA® daily.
Other: Néevo®/ NéevoDHA®
Néevo®/NéevoDHA® is an orally administered medical food indicated for the dietary management of impaired metabolic processes in women under a doctor's care who face high to intermediate risk pregnancies and are unable to fully metabolize or absorb folic acid. Néevo®/ NéevoDHA® contains L-methylfolate, the biologically active and immediately bioavailable form of folate.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358552
|United States, Texas|
|Noe Lira, M.D.|
|Corpus Christi, Texas, United States, 78411|
|Principal Investigator:||Noe Lira, M.D.||Noe Lira, M.D.|