Идёт набор NCT06952426

A Mobile App-Based Study to Evaluate Disease Burden and Treatment Patterns in Immunoglobulin A Nephropathy (IgAN) in the US

— Наблюдательное Immunoglobulin A Nephropathy

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: В протоколе указаны: No intervention, Other treatment, Iptacopan, Atrasentan.
Кому может быть актуально: Состояния в реестре: Immunoglobulin A Nephropathy. Базовые параметры: от 18 лет · 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

A Mobile App-Based, Prospective, Observational Study to Evaluate Disease Burden and Treatment Patterns in Immunoglobulin A Nephropathy (IgAN) in the US

Обзор

The study aims to longitudinally capture the full spectrum of symptoms, treatment utilization, and overall health-related quality of life (HRQoL) experienced by Immunoglobulin A nephropathy (IgAN) patients and their caregivers.

Подробное описание

This will be a prospective, observational study. Data will be collected using the Folia Health platform. Participation in the study will occur through use of the Folia mobile platform, where study participants will be directed to a study-specific platform environment to review and sign the consent form and enroll. Each participant will complete an initial 6-month study data collection period which includes home reported outcomes (HRO) tracking along with study specific components including a baseline survey, monthly check-in prompts, and endline study evaluation survey. After the 6-month period, participants can continue to use Folia to track their HROs for their own personal use. With their consent, the data they enter after the initial 6-month period may be reviewed for ongoing data integrations with Novartis APPRISE data platform for up to 2 years.

Вмешательства

Другое No intervention
Participants and their caregivers will report home reported outcomes (HRO) data on symptom burden to understand symptom variability and health-related quality of life (HRQoL).
Другое Other treatment
Participants and their caregivers will report HRO data on symptom burden and treatment usage to understand symptom variability and HRQoL.
Другое Iptacopan
Participants and their caregivers will report HRO data on symptom burden and treatment usage to understand symptom variability and HRQoL including those taking iptacopan.
Другое Atrasentan
Participants and their caregivers will report HRO data on symptom burden and treatment usage to understand symptom variability and HRQoL including those taking atrasentan.

Первичные конечные точки

Number of participants with IgAN specific symptoms [Срок оценки: monthly up to month 6]
Average self-reported severity of each of these top 10 symptoms [Срок оценки: monthly up to month 6]
Variability in self-reported severity of each of these top 10 symptoms [Срок оценки: monthly up to month 6]

Вторичные конечные точки (12)

Average temporal frequency of treatment administration, for each IgAN-specific treatment [Срок оценки: monthly up to month 6]
Number of participants by reason for skipping treatment [Срок оценки: monthly up to month 6]
Differences in symptom occurrence for participants in each treatment group [Срок оценки: monthly up to month 6]
Differences in symptom severity for participants in each treatment group [Срок оценки: monthly up to month 6]
Differences in symptom frequency for participants in each treatment group [Срок оценки: monthly up to month 6]
Change in average symptom occurrence from pre-treatment to post-treatment utilization, for participants who initiated iptacopan or atrasentan during the study period [Срок оценки: monthly up to month 6]
Change in average symptom severity from pre-treatment to post-treatment utilization, for participants who initiated iptacopan or atrasentan during the study period [Срок оценки: monthly up to month 6]
Change in average symptom frequency from pre-treatment to post-treatment utilization, for participants who initiated iptacopan or atrasentan during the study period [Срок оценки: monthly up to month 6]
Number of participants in each treatment group who are classified as having a high vs moderate vs low flare burden [Срок оценки: monthly up to month 6]
Change over time in monthly check-in responses assessing health-related quality of life (HRQoL), for participants in each treatment group [Срок оценки: monthly up to month 6]
Patient-reported outcome (PRO) scores for participants in each treatment group - FACIT-F [Срок оценки: monthly up to month 6]
Patient-reported outcome (PRO) scores for participants in each treatment group - EQ-5D-5L [Срок оценки: monthly up to month 6]

Критерии участия

Критерии включения

Diagnosis of IgAN, regardless of symptom or treatment history
Adult aged 18 or older; adult caregiver to an adult patient aged 18 or older; or adult caregiver to a pediatric patient under 18 years of age
US-based with a proficient understanding of and ability to read the English language