ChiCTR2300073090 版本V1.0 版本创建时间2023/06/30 17:04:53 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：

 ChiCTR2300073090 

最近更新日期：

Date of Last Refreshed on：

 2023-06-30 17:03:33 

注册时间：

Date of Registration：

 2023-06-30 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Public title：

Effects of a nurse-led supportive care programme for people with progressive neurological diseases on psycho-spiritual well-being

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Scientific title：

Effects of a nurse-led palliative care programme, ‘Cultivating Acceptance and Living Meaningfully with Progressive Neurological Diseases’ (CALM-Neuro), on psycho-spiritual well-being: A mixed-method randomised controlled trial

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：

UW22-727

申请注册联系人：

 

研究负责人：

 

Applicant：

Lily Man Lee CHAN 

Study leader：

Lily Man Lee CHAN 

申请注册联系人电话：

Applicant telephone：

 +852 3917 6329

研究负责人电话：

Study leader's
telephone：

+852 3917 6329

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：

 cmlily@connect.hku.hk

研究负责人电子邮件：

Study leader's E-mail：

 cmlily@connect.hku.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：

研究负责人通讯地址：

Applicant address：

5/F, Academic Building, 3 Sassoon Road, Pokfulam, Hong Kong, China

Study leader's address：

5/F, Academic Building, 3 Sassoon Road, Pokfulam, Hong Kong, China

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：

Applicant's institution：

The University of Hong Kong

研究负责人所在单位：

Affiliation of the Leader：

The 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：

 UW22-727

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：

Name of the ethic committee：

Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster (HKU/HA HKW IRB)

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-12-22 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

Ms Jenny Ng

伦理委员会联系地址：

Contact Address of the ethic committee：

Room 901, 9/F, Administration Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 2255 3923

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 hkwirb@ha.org.hk

研究实施负责（组长）单位：

Primary sponsor：

The University of Hong Kong

研究实施负责（组长）单位地址：

Primary sponsor's address：

5/F, Academic Building, 3 Sassoon Road, Pokfulam, Hong Kong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

省(直辖市)：

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

具体地址：

Institution
hospital：

The University of Hong Kong

Address：

5/F, Academic Building, 3 Sassoon Road, Pokfulam, Hong Kong, China

经费或物资来源：

Source(s) of funding：

Nethersole Institute of Continuing Holistic Health Education Research Grant 2022/2023

研究疾病：

 

Target disease：

Parkinson's disease and multiple sclerosis

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：

随机平行对照 

Study design：

Parallel 

研究目的：

 

Objectives of Study：

To examine the effects of CALM-Neuro on improving psychological well-being (primary outcome) and secondary outcomes (spiritual well-being, meaning in life, symptom burden, psychological flexibility and distress related to death and dying) among patients with PNDs (PD and MS), compared with Befriending activity as active control.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

Participants will receive five 90-minutes sessions of a nurse-led palliative care programme for PNDs, namely ‘Cultivating Acceptance and Living Meaningfully with Progressive Neurological Diseases’ (CALM-Neuro) or Befriending activity over three months.  

纳入标准：

Inclusion criteria

Subjects will be eligible for recruitment if they: (i) are diagnosed with MS or idiopathic PD, (ii) score ≥ 8 on the Hospital Anxiety and Depression Scale-Depression subscale (sensitivity and specificity of approximately 0.80), (iii) aged 18 or above, (iv) fluent Cantonese speaker and (v) able to sign an informed consent form.

排除标准：

Exclusion criteria：

Individuals will be excluded if they (i) have severe cognitive impairment as indicated by the Abbreviated Mental Test lower than 6 (sensitivity and specificity of 0.94–0.96), (ii) are currently receiving psychotherapy/other behavioural interventions in the preceding six months, (iii) have prior experience in ACT-based intervention, or (iv) have other contraindication or severe comorbidity that may limit their full participation (e.g. severe hearing or vision impairment).

研究实施时间：

Study execute time：

从 From 2023-07-03 00:00:00至 To 2025-07-03 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-07-03 00:00:00 至 To 2025-04-03 00:00:00

干预措施：

Interventions：

组别：

样本量：

 69

Group：

1

Sample size：

干预措施：

干预措施代码：

Intervention：

CALM-Neuro: Each CALM-Neuro session comprises two main parts. The therapist takes a supportive–expressive approach in encouraging the open expression of thoughts and emotions and exploring the four domains: including 1) symptom management and communication with health care providers; 2) changes in self and relations with close other; 3) spiritual well-being, sense of meaning and purpose; and 4) preparing for the future, sustaining hope and facing mortality. The session will troubleshoot the psychological inflexibility in the context of the client’s problems by incorporating the six core elements of ACT. The therapist will adopt the techniques of experiential exercises, mindfulness and metaphors.

Intervention code：

组别：

样本量：

 69

Group：

2

Sample size：

干预措施：

干预措施代码：

Intervention：

Befriending activity: The sessions will focus on discussion of neutral, everyday topics and events (e.g. hobbies, pets and current affairs) which are of interest to participants and are not laden with negative affect. The therapy does not involve problem-solving or exploration of emotions. The therapist is asked to be warm, engaging and welcoming

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

省(直辖市)：

  

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

  

单位级别：

  

Institution
hospital：

The University of Hong Kong

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

指标类型：

主要指标

Outcome：

psychological wellbeing

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

次要指标

Outcome：

spiritual wellbeing

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

次要指标

Outcome：

meaning in life

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

次要指标

Outcome：

symptom burden

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

次要指标

Outcome：

psychological flexibility

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

次要指标

Outcome：

distress and dying Distress scale

Type：

Secondary 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：

组织：

Sample Name：

N/A

Tissue：

N/A

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

N/A

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）：

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

All eligible participants will be assigned with a sequential participant number. A computer-generated randomization sequence will be generated, participants will be assigned to either one of the two groups by an independent research assistant.

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：

All outcome assessors will be blinded to subject allocation.

是否共享原始数据：

IPD sharing

是Yes

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）：

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

The data will be available upon request after the study period.

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

The study leader will be responsible for using a data management plan (DMP) to describe the use of data, and depositing a dataset in the University of Hong Kong Scholars Hub.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2023-06-30 17:03:33