ChiCTR2100050869 版本V1.2 版本创建时间2022/05/08 22:41:50 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：

ChiCTR2100050869 

最近更新日期：

Date of Last Refreshed on：

2022-05-08 22:41:17 

注册时间：

Date of Registration：

2021-09-05 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Effectiveness of Home-based Family Caregiver-delivered Aromatherapy Programme for the Management of Behavioural and Psychological Symptoms of Dementia for Older Persons with Dementia

Public title：

Effectiveness of Home-based Family Caregiver-delivered Aromatherapy Programme for the Management of Behavioural and Psychological Symptoms of Dementia for Older Persons with Dementia

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Effectiveness of Home-based Family Caregiver-delivered Aromatherapy Programme for the Management of Behavioural and Psychological Symptoms of Dementia for Older Persons with Dementia

Scientific title：

Effectiveness of Home-based Family Caregiver-delivered Aromatherapy Programme for the Management of Behavioural and Psychological Symptoms of Dementia for Older Persons with Dementia

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：

Li Siu Yin 

研究负责人：

Li Siu Yin 

Applicant：

Li Siu Yin 

Study leader：

Li Siu Yin 

申请注册联系人电话：

Applicant telephone：

+852 68799737

研究负责人电话：

Study leader's telephone：

+852 68799737

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：

lisiuyin@link.cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

lisiuyin@link.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：

Tsuen Wan, N.T., Hong Kong, China

研究负责人通讯地址：

Tsuen Wan, N.T., Hong Kong, China

Applicant address：

Tsuen Wan, N.T., Hong Kong, China

Study leader's address：

Tsuen Wan, N.T., 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：

香港中文大學

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學

Affiliation of the Leader：

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：

2021.335

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：

2021-08-05 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：

中國香港特別行政區新界沙田銀城街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, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+852 35053935

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

Primary sponsor：

The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

中國香港特別行政區新界沙田銀城街香港中文大學

Primary sponsor's address：

The Chinese University of Hong Kong, Shatin, Hong Kong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中國

省(直辖市)：

香港特別行政區

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

香港中文大學

具体地址：

新界沙田銀城街

Institution
hospital：

The Chinese University of Hong Kong

Address：

Shatin, N.T., Hong Kong

经费或物资来源：

No

Source(s) of funding：

No

Target disease：

Dementia

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：

The objectives of the study are to evaluate the effectiveness of the programme in the following: 1. reducing Older persons with dementia (PWD)'s severity of BPSD symptoms, 2. improving PWD's quality of life (QoL), 3. decreasing family caregivers' distress, and 4. decreasing family caregivers' burden.  

Objectives of Study：

The objectives of the study are to evaluate the effectiveness of the programme in the following: 1. reducing Older persons with dementia (PWD)'s severity of BPSD symptoms, 2. improving PWD's quality of life (QoL), 3. decreasing family caregivers' distress, and 4. decreasing family caregivers' 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：

The PWD must satisfy the following criteria to be included in the study:
1. Aged 60 years or above;
2. Residing at home;
3. With a diagnosis of dementia of any type and stage of severity;
4. Presenting with at least one symptom of BPSD in the previous one month before the study;
5. Able to communicate in Cantonese or Mandarin.
The caregivers must satisfy the following criteria to be included in the study:
1. Family members, partners, or relatives living with PWD;
2. Provide unpaid daily care to PWD at home;
3. Literate in Chinese and able to communicate in Cantonese or Mandarin.

Inclusion criteria

The PWD must satisfy the following criteria to be included in the study:
1. Aged 60 years or above;
2. Residing at home;
3. With a diagnosis of dementia of any type and stage of severity;
4. Presenting with at least one symptom of BPSD in the previous one month before the study;
5. Able to communicate in Cantonese or Mandarin.
The caregivers must satisfy the following criteria to be included in the study:
1. Family members, partners, or relatives living with PWD;
2. Provide unpaid daily care to PWD at home;
3. Literate in Chinese and able to communicate in Cantonese or Mandarin.

排除标准：

PWD and their family caregivers are excluded from the study if either of them have:
1. Allergy or discomfort after using Lavender essential oil;
2. Other neurological or psychological diseases besides BPSD;
3. The following conditions: pregnancy, breastfeeding, hypotension, exacerbation of asthma, dyspnoea, epilepsy, or glucose-6-phosphate dehydrogenase deficiency;
4. Current use of the following drugs: anticoagulant Warfarin, antiplatelet Aspirin, central nervous system depressant, or anticonvulsant;
5. Hate the smell of Lavender or Lavender essential oil;
6. PWD have received aromatherapy in the past one month;
7. A change in family caregiver within 1 month before the study or during the study period.

Exclusion criteria：

PWD and their family caregivers are excluded from the study if either of them have:
1. Allergy or discomfort after using Lavender essential oil;
2. Other neurological or psychological diseases besides BPSD;
3. The following conditions: pregnancy, breastfeeding, hypotension, exacerbation of asthma, dyspnoea, epilepsy, or glucose-6-phosphate dehydrogenase deficiency;
4. Current use of the following drugs: anticoagulant Warfarin, antiplatelet Aspirin, central nervous system depressant, or anticonvulsant;
5. Hate the smell of Lavender or Lavender essential oil;
6. PWD have received aromatherapy in the past one month;
7. A change in family caregiver within 1 month before the study or during the study period.

研究实施时间：

Study execute time：

从 From 2021-08-26 00:00:00至 To 2022-09-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2021-08-26 00:00:00 至 To 2021-09-10 00:00:00  

干预措施：

Interventions：

组别：

Intervention Group

样本量：

88

Group：

Intervention Group

Sample size：

干预措施：

Home-based aromatherapy programme

干预措施代码：

Intervention：

Home-based aromatherapy programme

Intervention code：

组别：

Control group

样本量：

88

Group：

Control group

Sample size：

干预措施：

Conventional

干预措施代码：

Intervention：

Conventional

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

测量指标：

Outcomes：

指标中文名：

PWD's severity of BPSD

指标类型：

主要指标

Outcome：

PWD's severity of BPSD

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

PWD's quality of life

指标类型：

次要指标

Outcome：

PWD's quality of 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：

Family caregivers' distress

指标类型：

次要指标

Outcome：

Family caregivers' distress

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Family caregivers' burden

指标类型：

次要指标

Outcome：

Family caregivers' burden

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：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 60 岁 years
最大 Max age 100 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

The recruited PWD-family caregiver pairs will be randomly allocated into intervention or control group in 1:1 ratio by sealed envelope randomization. Every time when a PWD-family caregiver pair is recruited and consented to enter the study, an envelope will be randomly drawn by a person not involved in

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

The recruited PWD-family caregiver pairs will be randomly allocated into intervention or control group in 1:1 ratio by sealed envelope randomization. Every time when a PWD-family caregiver pair is recruited and consented to enter the study, an envelope will be randomly drawn by a person not involved in.

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：

Not stated

Blinding：

Not stated

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）：

On request

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

On 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：

On request

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

On request

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-09-05 20:25:42