NEPTUNE Match Study

Официальное название

Implementing Precision Medicine for Glomerular Diseases in the Nephrotic Syndrome Study Network (NEPTUNE)

Обзор

NEPTUNE Match is an additional opportunity offered to NEPTUNE study participants to prospectively recruit and communicate patient-specific clinical trial matching with kidney patients and their physician investigators.

Подробное описание

This is a prospective, open-label study testing the ability to effectively communicate patient-specific clinical trial matching with kidney patients and clinician investigators. The study consists of four components:

1. Recruitment of participants from the NEPTUNE observational cohort study 2. Generation of participant profile-trial match assessment using data from the NEPTUNE observational study and profiling units by the NEPTUNE Molecular Nephrology Board 3. Establishing and testing a framework to communicate disease-trial drug mechanism matching with investigators and patients 4. Retrospective comparison of kidney health outcomes in subjects enrolled in trials that aligned with their match vs. trial subjects with mis-aligned or unknown match alignment.

Вмешательства

• Другое Communication
  The NEPTUNE Match study includes an interdisciplinary Communication Team that will translate findings from the Molecular Nephrology Board (MNB) to inform patients of the matching assessment with ongoing clinical trials. This team has considerable experience with conveying complex biomedical research information to patients and families and includes experts in precision nephrology, nephrology patient \[adult and pediatric\] communication, and health education.

Первичные конечные точки

• Matched participants with at least one clinical trial receive a MNB assessment [Срок оценки: 0-4 weeks]
• Efficacy of communication methods at time of communication visit, measured by Teach Back 1 summary score [Срок оценки: 12 weeks]
• Kidney health endpoints that are specific to each individual trial [Срок оценки: 0-60 months]

Вторичные конечные точки (3)

• Efficacy of communication methods at follow up, measured by Teach Back of key concepts [Срок оценки: 14-18 weeks]
• Psychological distress measured by the STAI assessment [Срок оценки: 14-18 weeks]
• Psychological distress measured by the FACToR-NEPTUNE assessment [Срок оценки: 14-18 weeks]

Критерии участия

Критерии включения

• Consented and eligible participants in the biopsied or non-biopsied cohorts of the NEPTUNE observational study
• Must be potentially eligible for the NEPTUNE Match partnering trials (e.g. if no trial is enrolling a participant under age 6, those under 6 are not eligible).

Note: NEPTUNE Match partnering trials and associated eligibility criteria are expected to be dynamic and change as trial protocols are developed, activated, and amended.

• Regular nephrology healthcare provided at a NEPTUNE study site.
• Willing and able to consent, and as appropriate assent, to participate in NEPTUNE Match

Критерии исключения

Currently non-NEPTUNE observational study participants are not eligible to be matched to a clinical trial using these biomarker assessments.

Критерии исключения

1\. Non-English or non-Spanish speaking

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 16 центров

• Emory University Hospital - Children's Hospital of Atlanta — Atlanta
• John H. Stroger, Jr., Hospital of Cook County — Chicago
• University of Kansas Medical Center — Kansas City
• Johns Hopkins Medicine — Baltimore
• University of Michigan — Ann Arbor
• Children's Mercy Hospital — Kansas City
• Northwell/Cohen's Children's Hospital — New Hyde Park
• Columbia University Medical Center — New York
• … и ещё 8 центров

Публикации

• Gadegbeku CA, Gipson DS, Holzman LB, Ojo AO, Song PX, Barisoni L, Sampson MG, Kopp JB, Lemley KV, Nelson PJ, Lienczewski CC, Adler SG, Appel GB, Cattran DC, Choi MJ, Contreras G, Dell KM, Fervenza FC, Gibson KL, Greenbaum LA, Hernandez JD, Hewitt SM, Hingorani SR, Hladunewich M, Hogan MC, Hogan SL, Kaskel FJ, Lieske JC, Meyers KE, Nachman PH, Nast CC, Neu AM, Reich HN, Sedor JR, Sethna CB, Trachtm PMID 23325076
• Tao J, Mariani L, Eddy S, Maecker H, Kambham N, Mehta K, Hartman J, Wang W, Kretzler M, Lafayette RA. JAK-STAT signaling is activated in the kidney and peripheral blood cells of patients with focal segmental glomerulosclerosis. Kidney Int. 2018 Oct;94(4):795-808. doi: 10.1016/j.kint.2018.05.022. Epub 2018 Aug 6. PMID 30093081
• Ha Dinh TT, Bonner A, Clark R, Ramsbotham J, Hines S. The effectiveness of the teach-back method on adherence and self-management in health education for people with chronic disease: a systematic review. JBI Database System Rev Implement Rep. 2016 Jan;14(1):210-47. doi: 10.11124/jbisrir-2016-2296. PMID 26878928
• Marteau TM, Bekker H. The development of a six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI). Br J Clin Psychol. 1992 Sep;31(3):301-6. doi: 10.1111/j.2044-8260.1992.tb00997.x. PMID 1393159
• Tluczek A, Henriques JB, Brown RL. Support for the reliability and validity of a six-item state anxiety scale derived from the State-Trait Anxiety Inventory. J Nurs Meas. 2009;17(1):19-28. doi: 10.1891/1061-3749.17.1.19. PMID 19902657

Идентификаторы

NCT: NCT04571658 · HUM00158219-Sub · U54DK083912 · R01DK141114

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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