The Remote Monitoring of Gout Feasibility Study in Primary Care
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: Patient self-management app 'MinUrinsyregikt'.
- Кому может быть актуально
- Состояния в реестре: Gout. 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
- Норвегия
- 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
The Self-management App 'MinUrinsyregikt' for Patients With Gout. The ReMonit Gout Feasibility Study in Primary Care
Обзор
The goal of this feasibility study is to determine the feasibility of a patient self-management app (MinUrinsyregikt) for patients with gout. The primary objectives of the study are: 1. To determine the feasibility of a patient self-management app for patients with gout receiving GP follow-up. 2. To determine the feasibility of conducting a future randomised controlled trial to test the effectiveness of the app for patients with gout in primary care. Participants will be asked to test the self-management app for 3 months. Data will be collected from the participants and their GPs.
Подробное описание
The study is a single-group, decentralized feasibility study over 3 months with pre- and post-intervention measurements and data collections through the app. Patients and GPs will be recruited from primary care throughout Norway. 20-50 adults with a gout diagnosis, serum urate level \>360 μmol/L, and an indication for urate lowering therapy will be included in the study.
The patients will receive self-management support from the 'MinUrinsyregikt'-app in addition to usual follow-up from their GP. The study coordinator will provide instructions on how to download and use the app. The patients will register the following information in the app: whether they have tophi, type of urate lowering medication and dose, medical adherence, flares, and the serum urate level from the monthly blood test. The app will provide information about the date for the next blood test, reminders for blood tests and medication, and advice to contact their GP if the urate level is too high. The GPs will be responsible for the medical follow-up of the patients and will not have access to information from the app.
Data will be collected from participants through digital questionnaires at baseline. After 3 months participants and GPs will be asked to answer a digital questionnaire and be invited to participate in semi-structured interviews about their experiences with app-supported follow-up for gout.
Вмешательства
- Устройство Patient self-management app 'MinUrinsyregikt'
The purpose of the 'MinUrinsyregikt' -app is to support self-management for patients with gout receiving urate lowering therapy. The content of the app reflects current treatment recommendations for gout. The app includes information videos and texts about gout and gout treatment, registration tools for gout flares, serum urate levels, and medication adherence. The app enables reminder alerts for medications and for blood sampling. After the monthly blood test of serum urate levels, the patient
Первичные конечные точки
- Acceptable overall feasibility of the app based on a total evaluation of the secondary endpoints for technical and operational feasibility. [Срок оценки: 3 months]
- Acceptable overall trial feasibility based on the total evaluation of the secondary endpoints for trial feasibility. [Срок оценки: 3 months]
Вторичные конечные точки (12)
- Technical feasibility: Patient-reported errors in app [Срок оценки: 3 months]
- Technical feasibility: Patient-reported software performance and functionality [Срок оценки: 3 months]
- Technical feasibility: Patient-reported software usability [Срок оценки: 3 months]
- Technical feasibility: Patient-reported satisfaction with the app [Срок оценки: 3 months]
- Technical feasibility: Patient-repoted benefits and disadvantages of the app [Срок оценки: 3 months]
- Operational feasibility: Patients' training requirements [Срок оценки: 3 months]
- Operational feasibility: GP and patient-reported barriers and facilitators of app-supported gout follow-up [Срок оценки: 3 months]
- Operational feasibility: Patient satisfaction with the follow-up care [Срок оценки: 3 months]
- Trial feasibility: Number of eligible patients per month and recruitment rate [Срок оценки: 3 months]
- Trial feasibility: Patient dropout [Срок оценки: 3 months]
- Trial feasibility: Patients' app use [Срок оценки: 3 months]
- Trial feasibility: Barriers and facilitators to study participation for patients and GPs [Срок оценки: 3 months]
Критерии участия
Patients are eligible to be included in the study only if all the following criteria apply:
- Adults ≥18 years of age at screening
- Patients with a clinical diagnosis of gout
- Serum urate level >360 µmol/L at inclusion
- Indication for urate lowering therapy assessed by medical doctor
- Having a smartphone/tablet
Patients are excluded from the study if any of the following criteria apply:
- Pregnant or breastfeeding
- Contraindication for urate lowering therapy
- Does not understand Norwegian language
- Major co-morbidities (e.g., malignancies, severe chronic kidney disease, severe mental disorders)
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
- Лечение
Центры проведения
Норвегия · 1 центр
- Diakonhjemmet Hospital — Oslo
Идентификаторы
NCT: NCT07490522 · 966720 · 25/03734