ChiCTR2500112911 版本V1.0 版本创建时间2025/11/20 17:33:12 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：

 ChiCTR2500112911 

最近更新日期：

Date of Last Refreshed on：

 2025-11-20 17:32:56 

注册时间：

Date of Registration：

 2025-11-20 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Effectiveness of a Medical-Social Collaboration in Improving the Well-Being of People with Cognitive Impairment

Public title：

Effectiveness of a Medical-Social Collaboration in Improving the Well-Being of People with Cognitive Impairment

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Effectiveness of a Medical-Social Collaboration in Improving the Well-Being of People with Cognitive Impairment

Scientific title：

Effectiveness of a Medical-Social Collaboration in Improving the Well-Being of People with Cognitive Impairment

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：

Prof Timothy Kwok 

Applicant：

Bel Wong 

Study leader：

Prof Timothy Kwok 

申请注册联系人电话：

Applicant telephone：

 +852 2946 8191

研究负责人电话：

Study leader's
telephone：

+852 2636 6323

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：

No.27, A Kung Kok Street

研究负责人通讯地址：

No.27, A Kung Kok Street

Applicant address：

No.27, A Kung Kok Street

Study leader's address：

No.27, A Kung Kok Street

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：

Jockey Club Centre for Positive Ageing

Affiliation of the Leader：

Jockey Club Centre for Positive Ageing

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：

 2025.131-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：

The Joint CUHK-NTEC Clincial Research Ethics Committee

Name of the ethic committee：

The Joint CUHK-NTEC Clincial Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-05-13 00:00:00

伦理委员会联系人：

Amy Li

Contact Name of the ethic committee：

Amy Li

伦理委员会联系地址：

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

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：

 +852 3505 3935

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：

Jockey Club Centre for Positive Ageing

Primary sponsor：

Jockey Club Centre for Positive Ageing

研究实施负责（组长）单位地址：

No.27, A Kung Kok Street

Primary sponsor's address：

No.27, A Kung Kok Street

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

Jockey Club Centre for Positive Ageing

具体地址：

No.27, A Kung Kok Street

Institution
hospital：

Jockey Club Centre for Positive Ageing

Address：

No.27, A Kung Kok Street

经费或物资来源：

NA

Source(s) of funding：

NA

研究疾病：

dementia  

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：

 其它 

Study phase：

N/A

研究设计：

单臂 

Study design：

Single arm 

研究目的：

1. To investigate the effectiveness of a tailored intervention offered by an NGO in the hospital wards (medical-social collaboration) in improving the well-being of inpatients with cognitive impairment and their caregivers. 2. To examine the effectiveness of the intervention in reducing negative outcomes such as delirium, and facilitating ageing in place 3. To explore the feasibility of implementing this medical-social collaboration model.  

Objectives of Study：

1. To investigate the effectiveness of a tailored intervention offered by an NGO in the hospital wards (medical-social collaboration) in improving the well-being of inpatients with cognitive impairment and their caregivers. 2. To examine the effectiveness of the intervention in reducing negative outcomes such as delirium, and facilitating ageing in place 3. To explore the feasibility of implementing this medical-social collaboration model.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inpatients with cognitive impairment (N=250) 1. Aged 60 years old or above 2. People with ICD label of cognitive impairment, delirium, or confusion 3. Stayed in Shatin Hospital’s medicine and geriatrics wards Caregivers of inpatients with cognitive impairment (N=250) 1. Aged 18 years old or above 2. Caregivers of inpatient participants of this study Staff of Shatin Hospital (N=30) 1. Aged 18 years old or above 2. Staff of Shatin Hospital 3. Involved in this intervention programme, such as taking care of the participants, or offering intervention to them, or participating in the planning of the intervention of this programme

Inclusion criteria

Inpatients with cognitive impairment (N=250) 1. Aged 60 years old or above 2. People with ICD label of cognitive impairment, delirium, or confusion 3. Stayed in Shatin Hospital’s medicine and geriatrics wards Caregivers of inpatients with cognitive impairment (N=250) 1. Aged 18 years old or above 2. Caregivers of inpatient participants of this study Staff of Shatin Hospital (N=30) 1. Aged 18 years old or above 2. Staff of Shatin Hospital 3. Involved in this intervention programme, such as taking care of the participants, or offering intervention to them, or participating in the planning of the intervention of this programme

排除标准：

Inpatients with cognitive impairment (N=250) 1. Admission from elderly home 2. Unable to take part in intervention or research data collection 3. Not giving consent to research participation Caregivers of inpatients with cognitive impairment (N=250) 1. Unable to take part in intervention or research data collection 2. Not giving consent to research participation Staff of Shatin Hospital (N=30) 1. Not giving consent to research participation

Exclusion criteria：

Inpatients with cognitive impairment (N=250) 1. Admission from elderly home 2. Unable to take part in intervention or research data collection 3. Not giving consent to research participation Caregivers of inpatients with cognitive impairment (N=250) 1. Unable to take part in intervention or research data collection 2. Not giving consent to research participation Staff of Shatin Hospital (N=30) 1. Not giving consent to research participation

研究实施时间：

Study execute time：

从 From 2025-12-01 00:00:00至 To 2028-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-12-01 00:00:00 至 To 2028-06-30 00:00:00

干预措施：

Interventions：

组别：

Inpatients with cognitive impairment group

样本量：

 250

Group：

Inpatients with cognitive impairment group

Sample size：

干预措施：

Psychosocial intervention

干预措施代码：

Intervention：

Psychosocial intervention

Intervention code：

组别：

Caregiver group

样本量：

 250

Group：

Caregiver group

Sample size：

干预措施：

Caregiver support

干预措施代码：

Intervention：

Caregiver support

Intervention code：

组别：

Staff group

样本量：

 30

Group：

Staff group

Sample size：

干预措施：

None

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 Shatin Hospital 

单位级别：

 N/A 

Institution
hospital：

Shatin Hospital

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

quality of life

指标类型：

主要指标

Outcome：

quality of life

Type：

Primary indicator

测量时间点：

测量方法：

questionnaire

Measure time point of outcome：

Measure method：

questionnaire

指标中文名：

agitation

指标类型：

次要指标

Outcome：

agitation

Type：

Secondary indicator

测量时间点：

测量方法：

questionnaire

Measure time point of outcome：

Measure method：

questionnaire

指标中文名：

change of delirium

指标类型：

次要指标

Outcome：

change of delirium

Type：

Secondary indicator

测量时间点：

测量方法：

checking medical records

Measure time point of outcome：

Measure method：

checking medical records

指标中文名：

hospital length of stay

指标类型：

次要指标

Outcome：

hospital length of stay

Type：

Secondary indicator

测量时间点：

测量方法：

checking medical records

Measure time point of outcome：

Measure method：

checking medical records

指标中文名：

discharge destination

指标类型：

次要指标

Outcome：

discharge destination

Type：

Secondary indicator

测量时间点：

测量方法：

checking medical records

Measure time point of outcome：

Measure method：

checking medical records

指标中文名：

programme compliance

指标类型：

次要指标

Outcome：

programme compliance

Type：

Secondary indicator

测量时间点：

测量方法：

observation

Measure time point of outcome：

Measure method：

observation

指标中文名：

caregiving self-efficacy

指标类型：

次要指标

Outcome：

caregiving self-efficacy

Type：

Secondary indicator

测量时间点：

测量方法：

questionnaire

Measure time point of outcome：

Measure method：

questionnaire

指标中文名：

programme satisfaction

指标类型：

次要指标

Outcome：

programme satisfaction

Type：

Secondary indicator

测量时间点：

测量方法：

questionnaire

Measure time point of outcome：

Measure method：

questionnaire

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

None

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 18 岁 years
最大 Max age 100 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

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

No randomization

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

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）：

Upon request

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

Upon request

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：

The data of the well-being of the inpatient participatns, i.e. (a) QUALID-C, and (b) PAS will be collected in the format of interviews to ward staff by the researchers or the interveners. The ward staff will be interviewed by the researchers or the interveners about T0 baseline, i.e. past 7-day condition recall before 1st intervention session, and T1 post-intervention, i.e. 7-day condition after 2nd intervention session. The interview length would be within 10 minutes. The data of (c) change of delirium during hospital stay, (d) hospital length of stay, and (e) discharge destination of the inpatient participants will be collected through their medical records retrieved by the researchers from HA CMS or case records. The data of (f) programme compliance of the inpatient participants will be collected through in-intervention observation conducted by the researchers. The researchers will use a checklist designed based on dementia care mapping11 to record the behaviour and engagement of the inpatient participants as well as the engagement of the interveners during the intervention to meausre the programme compliance. A total of 12 intervention will be randomly selected for observation. The randomisation will be done by the rand() formula in Excel according to the intervention schedule. The data of (g) RSCSE and (h) programme satisfaction of the caregivers will be collected by means of caregiver online self-completion or in-person, phone, or online interviews by the interveners or the researchers, depending on the preference of the caregivers. RSCSE will be administed at two timepoints: T0 baseline, i.e. before the 1st intervnetion sesison, and T1 post-intervnetion, i.e. after the last caregiver supoprt sesison. Programme satisfiaction survey will be administered one-time at T1. The interview length would be within 10 minutes. The data of (h) programme satisfaction of the hospital staff will be collected by means of online self-completion or in-person interviews by the researchers, depending on the preference of the participants. The survey will be distributed to all targeted participants at two timepoints: (1) at the end of 1st year of intervention; and (2) at the end of the programme to maximise the completion coverage, the survey distributed at the two timepoints is the same, staff participants could choose to complete the survey at either one or both timepoints. The interview length would be within 10 minutes. Demographics data of the inpatient participants and caregiver participants will be collected from caregivers or CMS record for analysis purpose: patient age, patient sex, hospital length of stay, cognitive impairment type, principal diagnosis, comorbidity, medication, cognitive, mobility, and functional status during hospital admission and discharge, co-residing family members, CSSA/OALA usage; caregiver age, caregiver sex, whether caregiver lives with patient.

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

The data of the well-being of the inpatient participatns, i.e. (a) QUALID-C, and (b) PAS will be collected in the format of interviews to ward staff by the researchers or the interveners. The ward staff will be interviewed by the researchers or the interveners about T0 baseline, i.e. past 7-day condition recall before 1st intervention session, and T1 post-intervention, i.e. 7-day condition after 2nd intervention session. The interview length would be within 10 minutes. The data of (c) change of delirium during hospital stay, (d) hospital length of stay, and (e) discharge destination of the inpatient participants will be collected through their medical records retrieved by the researchers from HA CMS or case records. The data of (f) programme compliance of the inpatient participants will be collected through in-intervention observation conducted by the researchers. The researchers will use a checklist designed based on dementia care mapping11 to record the behaviour and engagement of the inpatient participants as well as the engagement of the interveners during the intervention to meausre the programme compliance. A total of 12 intervention will be randomly selected for observation. The randomisation will be done by the rand() formula in Excel according to the intervention schedule. The data of (g) RSCSE and (h) programme satisfaction of the caregivers will be collected by means of caregiver online self-completion or in-person, phone, or online interviews by the interveners or the researchers, depending on the preference of the caregivers. RSCSE will be administed at two timepoints: T0 baseline, i.e. before the 1st intervnetion sesison, and T1 post-intervnetion, i.e. after the last caregiver supoprt sesison. Programme satisfiaction survey will be administered one-time at T1. The interview length would be within 10 minutes. The data of (h) programme satisfaction of the hospital staff will be collected by means of online self-completion or in-person interviews by the researchers, depending on the preference of the participants. The survey will be distributed to all targeted participants at two timepoints: (1) at the end of 1st year of intervention; and (2) at the end of the programme to maximise the completion coverage, the survey distributed at the two timepoints is the same, staff participants could choose to complete the survey at either one or both timepoints. The interview length would be within 10 minutes. Demographics data of the inpatient participants and caregiver participants will be collected from caregivers or CMS record for analysis purpose: patient age, patient sex, hospital length of stay, cognitive impairment type, principal diagnosis, comorbidity, medication, cognitive, mobility, and functional status during hospital admission and discharge, co-residing family members, CSSA/OALA usage; caregiver age, caregiver sex, whether caregiver lives with patient.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-11-20 17:32:56