- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
정황
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Hong Kong, 중국
- Aberdeen General Outpatient Clinic,Hospital Authority
-
Hong Kong, 중국
- Department of Community Medicine,The University of Hong Kong
-
Hong Kong, 중국
- Eye Institute, Faculty of Medicine, The University of Hong Kong, Hong Kong
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- All diabetic patients who attend the clinic during the study period.
Exclusion Criteria:
- Only if not competent to give informed consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: free screening group
Subjects in this group receive free diabetic retinopathy screening.
|
The intervention is to provide free screening without charging a co-payment
|
|
다른: Pay screening group
Subjects in this group receive diabetic retinopathy screening with charging a co-payment.
|
The intervention is charging a co-payment of HK$60 for the Diabetic Retinopathy screening.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Retinopathy profile in the two groups
기간: the first year
|
The extent of diabetic retinopathy in two groups were measured in the first year screening.
|
the first year
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Subjects' attendance of the screening
기간: 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.
|
the first year
|
|
Retinopathy profile in the two groups
기간: the second year
|
The extent of diabetic retinopathy in two groups were measured in the second year screening.
|
the second year
|
|
Subjects' attendance of the screening
기간: the second year
|
Whether the subject attends the screening was measured and the attendance rate was estimated for two groups in the second year screening.
|
the second year
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Sarah M McGhee, PhD, The University of Hong Kong
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .