Идёт набор NCT06927219

Research Accelerated by You Lupus Registry

— Наблюдательное Systemic Lupus Erythematosus (SLE) Lupus Nephritis (LN) Cutaneous Lupus Erythematosus (CLE)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN), Cutaneous Lupus Erythematosus (CLE). Базовые параметры: Без ограничений · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Web-Based Data Collection Through the Research Accelerated by You (RAY) Lupus Registry

Обзор

Summary The Lupus Foundation of America (LFA) Research Accelerated by You (RAY) Registry is a fully remote, longitudinal registry designed to collect data from adults and children living with lupus. The primary goal is to better understand the diagnosis, treatment, care, and quality of life for those affected by the disease. Remote Participation This is a decentralized, online-only registry. Participation is conducted entirely through a secure web-based portal. There are no physical site visits or travel requirements; participants can contribute from any location with internet access. Participation Details Consent: Informed consent is completed electronically. Surveys: Participants complete electronic surveys upon enrollment and every six months thereafter. Data Types: Collected data is self-reported and includes demographics, diagnosis history, treatment information, and patient-reported outcomes (PROs), such as quality of life. Purpose and Data Use The LFA uses registry data to: Address Constituent Needs: Inform programs and resources for the lupus community. Advance Research: Share patient insights with to ensure therapies are developed with the consideration of what matters and what matters most to people living with lupus. Patient Engagement and Clinical Research Matching: Participants may be contacted to assess eligibility for patient engagement or clinical research opportunities or to complete specific sub-surveys regarding trial participation.

Подробное описание

This is a multinational, direct-to-patient registry available to patients in the United States and Canada. The registry will enroll 10,000 people living with lupus who have a diagnosis of:

* Systemic Lupus Erythematosus * Lupus Nephritis (Lupus Related Kidney Disease) * Skin-Only Lupus (Cutaneous Lupus) * Skin-Only Lupus With Scarring (Discoid Lupus) * Lupus Caused By Medication(S) (Drug-Induced Lupus)

The registry will include questions about demographics, diagnostic journey, signs and symptoms, treatments, impact of lupus on health and quality of life, patient report outcomes and preferences related to clinical trials. The registry will also collect information about fatigue and work productivity.

Первичные конечные точки

Functional Assessment of Chronic Illness Therapy-Fatigue Scale [Срок оценки: Over a 10 year period]
Work Productivity and Activity Impairment [Срок оценки: Over a 10 year period.]

Критерии участия

Критерии включения

For adults with lupus, the individual who completes the Registry:

is 18 years of age or older
has a self-reported diagnosis of lupus by a physician or health care provider
is willing and able to provide informed consent
is able to read and understand English sufficiently to complete the survey questions
has access to a computer with an internet connection

For children under 18 with lupus, the individual who completes the Registry is:

18 years of age or older
the parent/legal guardian/legally authorized representative of a child under 18 years of age that has a diagnosis of lupus by a physician or health care provider
willing and able to provide consent for the child under 18 years of age and to obtain assent from the child between 7-17 years of age
able to access a computer with an internet connection
able to read and understand English sufficiently to complete the survey questions

For adults with lupus unable to provide consent, the individual who completes the Registry is:

18 years of age or older
the legally authorized representative of an adult 18 or older who is unable to provide consent and has a diagnosis of lupus by a physician or health care provider
willing and able to provide consent for the adult with lupus
able to access a computer with an internet connection
able to read and understand English sufficiently to complete the survey questions