- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01628289
The Cost-effectiveness of Screening for Diabetic Retinopathy in Hong Kong
Introduction: There is no debate that people with diabetes should be screened for the development of retinopathy which can threaten their sight. However, there is no routine screening for retinopathy in Hong Kong at present. Many overseas countries find that they miss a large proportion of their target population and, with reliance on co-payments for screening, as is the case with the limited opportunistic screening at present, the cost-effectiveness of any routine service in Hong Kong could be reduced as is predicted by Hart's inverse care law.
Aim: This study will determine the potential cost-effectiveness of screening for retinopathy in Hong Kong under a free system and one in which a co-payment is charged.
Methods: Primary care patients attending General Outpatient Clinics on Hong Kong Island for their routine diabetic care will randomly be offered screening either at no charge or with the normal co-payment of $65. Those who are willing and unwilling to be screened will be compared for their clinical, lifestyle and socioeconomic characteristics and those unwilling will be asked their reasons. The uptake of screening at no fee and with a payment will be compared as will the prevalence of retinopathy in the two fee groups. Subsequent screening at one year will be offered at the same fee and uptake again compared.
The principal analyses will (a) identify the characteristics of those willing to be screened and reasons for not being screened (b) the uptake of screening when a co-payment is charged compared to when it is free (c) whether there is a difference in the prevalence of retinopathy between the group willing to pay and those who accept free screening and (d) the uptake of re-screening in year 2.
The resulting cost-effectiveness model will use these data, the cost data collected during the study and overseas data on benefits of treatment to model the cost-effectiveness of screening for retinopathy in Hong Kong if it were to be offered free or with a co-payment. This information will be important to determine the most cost-effective means of implementing this preventative strategy to preserve sight and quality of life.
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Hong Kong, Китай
- Aberdeen General Outpatient Clinic,Hospital Authority
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Hong Kong, Китай
- Department of Community Medicine,The University of Hong Kong
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Hong Kong, Китай
- Eye Institute, Faculty of Medicine, The University of Hong Kong, Hong Kong
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- All diabetic patients who attend the clinic during the study period.
Exclusion Criteria:
- Only if not competent to give informed consent
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Другой: free screening group
Subjects in this group receive free diabetic retinopathy screening.
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The intervention is to provide free screening without charging a co-payment
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Другой: Pay screening group
Subjects in this group receive diabetic retinopathy screening with charging a co-payment.
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The intervention is charging a co-payment of HK$60 for the Diabetic Retinopathy screening.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Retinopathy profile in the two groups
Временное ограничение: the first year
|
The extent of diabetic retinopathy in two groups were measured in the first year screening.
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the first year
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Subjects' attendance of the screening
Временное ограничение: the first year
|
Whether the subject attends the screening was measured and the attendance rate was estimated for two groups in the first year screening.
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the first year
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Retinopathy profile in the two groups
Временное ограничение: the second year
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The extent of diabetic retinopathy in two groups were measured in the second year screening.
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the second year
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Subjects' attendance of the screening
Временное ограничение: the second year
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Whether the subject attends the screening was measured and the attendance rate was estimated for two groups in the second year screening.
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the second year
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Sarah M McGhee, PhD, The University of Hong Kong
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- UW 08-134
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. .