ChiCTR2300068920 版本V1.2 版本创建时间2023/05/21 07:13:18 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：

 ChiCTR2300068920 

最近更新日期：

Date of Last Refreshed on：

 2023-05-13 21:52:48 

注册时间：

Date of Registration：

 2023-03-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

低龄痴呆患者原发性进行性失语症的患病率及语言治疗对改善词汇检索和减轻护理负担的有效性

Public title：

Prevalence of Primary Progressive Aphasia in Younger Onset Dementia and Effectiveness of a Speech Therapy on Improving Lexical Retrieval and Reducing Caregiving Burden

注册题目简写：

English Acronym：

研究课题的正式科学名称：

低龄痴呆患者原发性进行性失语症的患病率及语言治疗对改善词汇检索和减轻护理负担的有效性

Scientific title：

Prevalence of Primary Progressive Aphasia in Younger Onset Dementia and Effectiveness of a Speech Therapy on Improving Lexical Retrieval and Reducing Caregiving Burden

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：

Bel Wong 

研究负责人：

Professor Timothy KWOK 

Applicant：

Bel Wong 

Study leader：

Professor Timothy KWOK 

申请注册联系人电话：

Applicant telephone：

 +852 26366323

研究负责人电话：

Study leader's
telephone：

+852 35053145

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：

 bel.wong@jccpa.org.hk

研究负责人电子邮件：

Study leader's E-mail：

 tkwok@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：

香港沙田亚公角街27号

研究负责人通讯地址：

香港新界沙田区香港中文大学医学院医学及药物治疗学系

Applicant address：

27 A Kung Kok Street, Shatin, Hong Kong

Study leader's address：

The Chinese University of Hong Kong, Shatin, 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：

Jockey Club Centre for Positive Ageing

Applicant's institution：

Jockey Club Centre for Positive Ageing

研究负责人所在单位：

香港中文大学医学院医学及药物治疗学系

Affiliation of the Leader：

Department of Medicine and Therapeutics, Faculty of Medicine, the Chinese University of Hong Kong

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2022.567-T

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：

 2022-12-12 00:00:00

伦理委员会联系人：

Envy Lee

Contact Name of the ethic committee：

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, 30-32 Yincheng Street, Shatin, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 26466653

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：

香港中文大学医学院医学及药物治疗学系

Primary sponsor：

Department of Medicine and Therapeutics, Faculty of Medicine, the Chinese University of Hong Kong

研究实施负责（组长）单位地址：

香港新界沙田区香港中文大学医学院医学及药物治疗学系

Primary sponsor's address：

The Chinese University of Hong Kong, Shatin, 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)：

香港中文大学医学院医学及药物治疗学系

具体地址：

新界沙田区

Institution
hospital：

Department of Medicine and Therapeutics, Faculty of Medicine, the Chinese University of Hong Kong

Address：

Shatin

经费或物资来源：

NA

Source(s) of funding：

NA

研究疾病：

痴呆  

Target disease：

Dementia

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

单臂 

Study design：

Single arm 

研究目的：

1. 探讨香港年轻痴呆患者中原发性进行性失语(PPA)的患病率。 2. 建立三层言语语言治疗提高词汇检索和减轻照顾负担的研究和临床证据。  

Objectives of Study：

1. To investigate prevalence of primary progressive aphasia (PPA) in younger onset dementia population in Hong Kong. 2. To establish research and clinical evidence of a three-tier speech-and-language therapy on improving lexical retrieval and reducing caregiving burden.

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. 患病率研究参与者(n=250)： (1) 由专家或全科医生诊断较早发病的痴呆症； (2) 年龄在40 - 65岁之间。 2. PPA阳性的参与者(n=83)： (1) 由专家或全科医生诊断较早发病的痴呆症； (2) 以广东话为母语，在参加建议研究前，60%的日常交流以广东话进行10年以上； (3) 年龄在40 - 65岁之间； (4) 接受过至少6年的正规教育； (5) 原发性进展性失语症(CLAP)中文评估中至少一项测试未通过，诊断可能为阳性的原发性进展性失语症(PPA)。 3. 承担PPA可能呈阳性的痴呆患者照顾者角色的参与者进行小组干预(n=83)。 4. 为老年人或认知障碍者提供服务的保健工作者进行群体干预(以知识转移为目的)(n=20)。

Inclusion criteria

1. Participants for prevalence study (n=250): (1) Diagnosis of younger onset dementia by specialists or general practitioners; (2) Aged between 40 – 65 years. 2. Participants with positive PPA (n=83): (1) Diagnosis of younger onset dementia by specialists or general practitioners; (2) Native Cantonese speaker, speaking Cantonese for more than 10 years for 60% of daily communication before joining the proposed study; (3) Aged between 40 – 65 years; (4) Received at least 6 years of formal education; (5) Diagnosis of possible positive primary progressive aphasia (PPA) by failing at least one subtest in the Chinese Language Assessment in Primary Progressive Aphasia (CLAP) for group intervention. 3. Participants with roles of Caregivers of participants with dementia with possible positive PPA for group intervention (n=83). 4. Participants who are Healthcare workers providing services for elderly or people with cognitive impairment for group intervention (participation for knowledge transfer purpose) (n=20).

排除标准：

1. 伴有重大脑部疾病(包括但不限于CVA、PD、脑肿瘤或TBI)。 2. 双耳听力水平> 35 dB HL/ dB SPL(未配备助听器)。 3. 视力低于6/12至6/18。中度-视力低于6/18至6/60(未经晶状体矫正)。 4. 无言语输出(静音)。 5. 学习障碍或儿童发育障碍史，包括但不限于自闭症谱系障碍/广泛性儿童发育障碍、阿斯伯格综合症、多动症或唐氏综合症。

Exclusion criteria：

1. Concomitant major brain disease (including but not limited to CVA, PD, brain tumour, or TBI). 2. Hearing levels > 35 dB HL/ dB SPL on both ears (not fitted with hearing aids). 3. Visual acuity worse than 6/12 to 6/18. Moderate –visual acuity worse than 6/18 to 6/60 (not corrected by lens). 4. No verbal language output (mute). 5. History of learning disabilities or pediatric development disorders including but not limited to autism spectrum disorders/pervasive childhood developmental disorders, Aspergers syndrome, ADHD, or Downs syndrome.

研究实施时间：

Study execute time：

从 From 2023-03-01 00:00:00至 To 2025-09-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-03-01 00:00:00 至 To 2025-09-30 00:00:00

干预措施：

Interventions：

组别：

原发性进行性失语症组

样本量：

 83

Group：

Group of primary progressive aphasia

Sample size：

干预措施：

语言治疗

干预措施代码：

Intervention：

Speech therapy

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)：

 Jockey Club Centre for Positive Ageing 

单位级别：

 NA 

Institution
hospital：

Jockey Club Centre for Positive Ageing

Level of the institution：

NA

测量指标：

Outcomes：

指标中文名：

词汇检索的准确性

指标类型：

主要指标

Outcome：

accuracy of lexical retrieval

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

NA

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

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 40 岁 years
最大 Max age 65 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）：

No randomization, this is one-arm study with only intervention group.

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

No randomization, this is one-arm study with only intervention group.

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：

No randomization, this is one-arm study with only intervention group.

Blinding：

No randomization, this is one-arm study with only intervention group.

是否共享原始数据：

IPD sharing

否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）：

NA

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

NA

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：

Data collection for the intervention will be conducted by researchers at The Education University of Hong Kong trained by Co-I. The primary and secondary outcomes for PwYOD and PPA and their caregivers will be collected by five time-points: (1) before Tier 1 treatment, (2) after Tier 1 treatment and before Tier 2 treatment, (3) after Tier 2 treatment and before Tier 3 treatment, (4) one week after Tier 3 treatment, and (5) four weeks after Tier 3 treament. The time for data collection of PwYOD with PPA will be around 100 minutes, that for the caregivers will be around 10 minutes. Videos / audios will be taken for data collection after collecting informed consent from the participants. Data collection for the healthcare workers will be conducted with a self-administered survey after Tier 1 and Tier 2 treatments.

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

Data collection for the intervention will be conducted by researchers at The Education University of Hong Kong trained by Co-I. The primary and secondary outcomes for PwYOD and PPA and their caregivers will be collected by five time-points: (1) before Tier 1 treatment, (2) after Tier 1 treatment and before Tier 2 treatment, (3) after Tier 2 treatment and before Tier 3 treatment, (4) one week after Tier 3 treatment, and (5) four weeks after Tier 3 treament. The time for data collection of PwYOD with PPA will be around 100 minutes, that for the caregivers will be around 10 minutes. Videos / audios will be taken for data collection after collecting informed consent from the participants. Data collection for the healthcare workers will be conducted with a self-administered survey after Tier 1 and Tier 2 treatments.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-03-01 20:53:55