Néevo®/NéevoDHA® P.L.U.S. Program (Progress Through Learning, Understand & Support)

April 30, 2013 updated by: Pamlab, Inc.
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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

53

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Corpus Christi, Texas, United States, 78411
        • Noe Lira, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant women who have been prescribed Néevo®/ NéevoDHA®

Description

Inclusion Criteria:

  • New Néevo®/NéevoDHA® Start.
  • Only for women who are pregnant and taking brand name Néevo®/ NéevoDHA® under a physicians care.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Néevo®/NéevoDHA®
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the safety and tolerability of Néevo®/NéevoDHA® as measured by side effects and compliance
Time Frame: Week 4
To collect data from patient surveys on the patient utilization and effectiveness of Néevo®/NéevoDHA® in a "real world" setting.
Week 4

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine overall patient satisfaction with Néevo®/NéevoDHA® using a 9-point satisfaction scale
Time Frame: Week 4
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamlab, Inc.

Collaborators

InfoMedics, Inc.

Investigators

  • Principal Investigator: Noe Lira, M.D., Noe Lira, M.D.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

May 18, 2011

First Submitted That Met QC Criteria

May 20, 2011

First Posted (Estimate)

May 23, 2011

Study Record Updates

Last Update Posted (Estimate)

May 1, 2013

Last Update Submitted That Met QC Criteria

April 30, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • N-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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