ChiCTR2300067374 版本V1.1 版本创建时间2023/05/12 15:30:40 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2300067374 

最近更新日期：

Date of Last Refreshed on：

2023-01-05 16:29:10 

注册时间：

Date of Registration：

2023-01-05 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

堅毅力和應對方式會否緩和永久視力損害帶來的焦慮和抑鬱？混合研究方法

Public title：

Do Grit and Coping Styles Moderate the Effect of Permanent Visual Impairment on Anxiety and Depression? Mixed-method Study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

堅毅力和應對方式會否緩和永久視力損害帶來的焦慮和抑鬱？混合研究方法

Scientific title：

Do Grit and Coping Styles Moderate the Effect of Permanent Visual Impairment on Anxiety and Depression? Mixed-method Study

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Ms Jennifer Tsoi 

研究负责人：

吳兆駿醫生 

Applicant：

Ms Jennifer Tsoi 

Study leader：

Dr NG Siu Chun Danny 

申请注册联系人电话：

Applicant telephone：

+852 39435818

研究负责人电话：

Study leader's telephone：

+852 3943 0702

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

jennifertsoi@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

dannyng@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

香港九龍亞皆老街147K號香港眼科醫院3樓

研究负责人通讯地址：

香港九龍亞皆老街147K號香港眼科醫院4樓

Applicant address：

3/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong

Study leader's address：

4/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

香港中文大學眼科及視覺科學學系

Applicant's institution：

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學眼科及視覺科學學系

Affiliation of the Leader：

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2022.342

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2022-08-05 00:00:00

伦理委员会联系人：

Ms Envy Lee

Contact Name of the ethic committee：

Ms Envy Lee

伦理委员会联系地址：

香港新界沙田銀城街30-32號威爾士親王醫院呂志和臨床醫學大樓8樓

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

香港中文大學眼科及視覺科學學系

Primary sponsor：

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

香港九龍亞皆老街147K號香港眼科醫院4樓

Primary sponsor's address：

4/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

香港

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

香港中文大學眼科及視覺科學學系

具体地址：

香港九龍亞皆老街147K號香港眼科醫院4樓

Institution
hospital：

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

Address：

4/F, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong

经费或物资来源：

香港中文大學眼科及視覺科學學系

Source(s) of funding：

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

Target disease：

Permanent vision impairment

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

连续入组 

Study design：

Sequential 

研究目的：

本研究讓我們明白堅毅力和應對方式對於永久視力損害帶來的焦慮和抑鬱的緩和成效其結果將有助日後設計針對會造成永久損害視力的眼病的心理輔導支援安排。  

Objectives of Study：

This research project will allow us to understand the moderating effect between permanent vision impairment and grit, and coping styles, and help advance the clinical management of providing psychological counselling services for patients with visual-threatening diseases.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1) Having experienced any degrees of permanent vision impairment for at least 6 months
2) Causes of vision loss must be acquired eye diseases only
3) Aged 18 or above
4) Cognitively healthy to give consent
5) Able to comprehend Cantonese to conduct the questionnaires and interview

Inclusion criteria

1) Having experienced any degrees of permanent vision impairment for at least 6 months
2) Causes of vision loss must be acquired eye diseases only
3) Aged 18 or above
4) Cognitively healthy to give consent
5) Able to comprehend Cantonese to conduct the questionnaires and interview

排除标准：

Any other causes will not be included in the study, e.g., congenital blindness, stroke damaging the optic chiasm, somatisation of stress.

Exclusion criteria：

Any other causes will not be included in the study, e.g., congenital blindness, stroke damaging the optic chiasm, somatisation of stress.

研究实施时间：

Study execute time：

从 From 2023-01-09 00:00:00至 To 2023-09-18 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2023-01-09 00:00:00 至 To 2023-09-18 00:00:00  

干预措施：

Interventions：

组别：

任何程度永久視力損害患者

样本量：

150

Group：

Subjects with any degree of permanent vision loss

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 香港 

市(区县)：

  

Country：

China 

Province：

Hong Kong 

City：

 

单位(医院)：

香港中文大學眼科中心 

单位级别：

 

Institution
hospital：

CUHK Eye Centre

Level of the institution：

测量指标：

Outcomes：

指标中文名：

Quality of life and daily functional ability after experiencing visual loss

指标类型：

主要指标

Outcome：

Quality of life and daily functional ability after experiencing visual loss

Type：

Primary indicator

测量时间点：

1次隨訪

测量方法：

美國全國眼科學院視覺功能問卷 – 25

Measure time point of outcome：

1 visit

Measure method：

National Eye Institute Visual Functioning Questionnaire 25 (CHI-VFQ-25)

指标中文名：

堅毅力

指标类型：

主要指标

Outcome：

Participants’ level of grit

Type：

Primary indicator

测量时间点：

1次隨訪

测量方法：

Short Grit Scale (Grit – S)

Measure time point of outcome：

1 visit

Measure method：

Short Grit Scale (Grit – S)

指标中文名：

應對方式

指标类型：

主要指标

Outcome：

Participants’ coping styles

Type：

Primary indicator

测量时间点：

1次隨訪

测量方法：

問題處理?式調查

Measure time point of outcome：

1 visit

Measure method：

Brief Cope

指标中文名：

焦慮和抑鬱程度

指标类型：

主要指标

Outcome：

Participants’ level of anxiety and depression

Type：

Primary indicator

测量时间点：

1次隨訪

测量方法：

Hospital Anxiety and Depression Scale (HADS)

Measure time point of outcome：

1 visit

Measure method：

Hospital Anxiety and Depression Scale (HADS)

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

N/A

Randomization Procedure (please state who generates the random number sequence and by what method)：

N/A

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Blinding：

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

N/A

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

N/A

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

Patient data would be handled with utmost care taking care not to breach patient's privacy in any form. The data would be stored in secure cabinets and/or computers which would be password operated. To protect patient privacy, all research data would be handled in line with HA / Hospital’s policy in handling / storage / destruction of patients’ medical records. Electronic data would be saved in secured computer of the hospital with restricted access. USB Device would not be used for patient information nor personal data. Personal data (name, HKID, OPD / hospital numbers, address and any other personal identifiable information) would not be recorded on the project’s data sheets or electronic files. A study code would be used instead. The document of electronic file containing the linkage information between the study code and the identity of the patient would not contain any other information and would be kept separate from the study data files or data sheets with the same stringent security as the medical record. Any documents or electronic files containing personal identifiable information would be considered as part of the medical record and would be dealt with the same stringent regulations of security according to the hospital policies. All the investigators would be responsible for data handling and protection. All identifiable personal data will be anonymised and will follow the HA policy on handling of patient data privacy.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Patient data would be handled with utmost care taking care not to breach patient's privacy in any form. The data would be stored in secure cabinets and/or computers which would be password operated. To protect patient privacy, all research data would be handled in line with HA / Hospital’s policy in handling / storage / destruction of patients’ medical records. Electronic data would be saved in secured computer of the hospital with restricted access. USB Device would not be used for patient information nor personal data. Personal data (name, HKID, OPD / hospital numbers, address and any other personal identifiable information) would not be recorded on the project’s data sheets or electronic files. A study code would be used instead. The document of electronic file containing the linkage information between the study code and the identity of the patient would not contain any other information and would be kept separate from the study data files or data sheets with the same stringent security as the medical record. Any documents or electronic files containing personal identifiable information would be considered as part of the medical record and would be dealt with the same stringent regulations of security according to the hospital policies. All the investigators would be responsible for data handling and protection. All identifiable personal data will be anonymised and will follow the HA policy on handling of patient data privacy.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-01-05 16:28:58