- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07923292
To Investigate the Feasibility and Acceptability of Trained Non-medical Professionals Performing Laser Treatment for Proliferative Diabetic Retinopathy (PDR), and the Potential Impact on Service Capacity. Assess Feasibility of Conducting a Full Trial Comparing Trained ECPs With Ophthalmologists (Avenue-PDR)
Assessing the Viability of Non-medical Practitioners Conducting Photocoagulation for PDR (AVENUE-PDR): A Feasibility Trial
To Investigate the Feasibility and Acceptability of Trained Non-medical Professionals Performing Laser Treatment for Proliferative Diabetic Retinopathy (PDR), and the Potential Impact on Service Capacity.
To assess Feasibility of Conducting a Full Trial Comparing Trained ECPs With Ophthalmologists in performing laser treatment in line with the established protocols.
Обзор исследования
Статус
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Swansea, Соединенное Королевство
- Рекрутинг
- Swansea Bay University Health Board: Ophthalmology Department, Singleton Hospital
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Контакт:
- Mahmoud Mr Awad
- Номер телефона: +44 1792 285034
- Электронная почта: mahmoud.awad@wales.nhs.uk
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- People with diabetes
- Proliferative diabetic retinopathy
- Aged18 years or over
- New referrals
Exclusion Criteria:
- Follow up appointments i.e. treatment already started
- Eye complications which may make laser treatment difficult
- Vitreous haemorrhage
- Dense media opacity
- Eye care complications which prevent a view of the retina
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Другой
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Другой: Opthalmologist
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Trained non-medical professionals (eye care practitioners (ECPs)) performing laser treatment for proliferative diabetic retinopathy (PDR), and the potential impact on service capacity |
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Другой: Trained non-medical professionals (eye care practitioners (ECPs)
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Trained non-medical professionals (eye care practitioners (ECPs)) performing laser treatment for proliferative diabetic retinopathy (PDR), and the potential impact on service capacity |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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To assess the feasibility of a full clinical trial comparing trained Eye Care Professionals with ophthalmologists in performing laser treatment in line with the established protocols
Временное ограничение: from enrollment to the 6 month follow up visit
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Feasibility will be assessed using pre-specified progression criteria relating to: ECP participation and training completion, participant recruitment, follow-up completion, intervention compliance and retention of clinical equipoise. We will use Red, Amber, Green criteria to determine whether a larger scale trial can be done |
from enrollment to the 6 month follow up visit
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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estimate participant recruitment and retention rates.
Временное ограничение: from baseline to 6 month visit
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to provide an estimate of the consent rates and retention rates by counting the number of patients screened and approached and how many consented. Of those, we will determine how many remained for the full 6 months and if patients withdrew or were lost to follow up we will determine when this occured and, where possible, why |
from baseline to 6 month visit
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assess completeness and quality of outcome data collection.
Временное ограничение: from baseline to 6 month visit
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to assess how well data is collected and how accurate it is by conducting a data cleasning exercise in the database to identify which data are missing and any outliers suggesting data is inaccurate |
from baseline to 6 month visit
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evaluate the feasibility of intervention delivery by trained ECPs
Временное ограничение: from baseline to 6 month visit
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to evalaute whether it is feasible for trained ECPs to deliver the treatment and whether patients accept them. this will include assessing (usign RAG criteria) whether ECPs agree to take part |
from baseline to 6 month visit
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assess the acceptability of the intervention and trial processes to participants and stakeholders.
Временное ограничение: from baseline to 6 month visit
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to assess whether patients consent and remain in the trial and whether stakeholders can adhere to the protocol |
from baseline to 6 month visit
|
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describe clinical outcome distributions to inform the design of a future definitive trial
Временное ограничение: from baseline to 6 month visit
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we will determine how will various clinical data items are collected in terms of availability and accuracy to determine whether they are suitable for a larger scale study which may use one as the basis for a sample size calculation. Data include number of laser sessions, visual acuity, central retinal thickness, sight loss/retention and various patient questionnaires |
from baseline to 6 month visit
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assess the feasibility of collecting patient-reported outcome and resource-use measures
Временное ограничение: from baseline to 6 month visit
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to determine whether participants complete the questionnaires provided and which questions are missed out / incorrecty completed. We will run missing data reports on the questionnaires to track patterns relating to problematic questions and identify outliers which may be incorrect data |
from baseline to 6 month visit
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explore the resource use and cost drivers associated with ECP-delivered and ophthalmologist-delivered care pathways.
Временное ограничение: from baseline to 6 month visit
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to collect data related to recourse use and other cost drivers associated with the novel treatment pathway using ECPs to determine whether there are cost savings to be made in using ECPs to deliver laser treatment |
from baseline to 6 month visit
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Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- IRAS 347120
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .