Metanx® P.L.U.S. Program (Progress Through Learning, Understanding & Support)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- To determine if Metanx® improves neuropathic symptoms as evaluated by the Neuropathy Total Symptom Score-6 (NTSS-6)
研究概览
简要总结
This study will be an observational study in which patients who have been prescribed Metanx® are invited to participate in surveys regarding their experiences with Metanx®. The purpose of this study is to increase the understanding of the role of Metanx® in managing diabetic neuropathy, provide patients with personalized education and support, and contribute to the overall understanding of the needs and concerns of patients being treated for diabetic neuropathy.
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 Metanx® has been prescribed and provide them with a brochure containing an introduction to the program and instructions on how to enroll. Patients self-enroll, take a brief survey before starting their Metanx® prescription, and then two brief follow-up surveys at 6 weeks and 12 weeks. 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 Metanx® as directed. Patients will also receive educational materials about managing their diabetic neuropathy.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •New Metanx® Start
- •Diagnosis of Diabetic Peripheral Neuropathy who have been prescribed Metanx® to help metabolic management of endothelial dysfunction.
排除标准
- •Patients who do not meet ADA criteria for DPN diagnosis.
- •If participant indicates that he or she did not get a prescription for Metanx®, he/she will not be able to complete the survey(s).
- •For follow-up surveys, if the participant indicates that he/she has not been taking Metanx®, he/she will not be able to complete the survey(s).
结局指标
主要结局
To determine if Metanx® improves neuropathic symptoms as evaluated by the Neuropathy Total Symptom Score-6 (NTSS-6)
时间窗: Baseline, Week 6 and Week 12
次要结局
- To determine if Metanx® affects a subject's pain level using a 10-point Visual Analog Scale (VAS)(Baseline, Week 6 and Week 12)
- To determine if Metanx® affects a subject's "quality of life" as determined by a symptom impact module.(Baseline, Week 6 and Week 12)
- To determine overall patient satisfaction with Metanx® using a 10-point satisfaction scale(Baseline, Week 6 and Week 12)