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社区康复干预对听力障碍人群生命质量的影响及成本效果评价
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注册号:

Registration number:

ChiCTR1900024739 

最近更新日期:

Date of Last Refreshed on:

2020-03-02 

注册时间:

Date of Registration:

2019-07-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

社区康复干预对听力障碍人群生命质量的影响及成本效果评价 

Public title:

Impact and cost-effectiveness evaluation of community-based rehabilitative interventions on quality of life among adults with hearing loss 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

社区康复干预对听力障碍人群生命质量的影响及成本效果评价 

Scientific title:

Impact and cost-effectiveness evaluation of community-based rehabilitative interventions on quality of life among adults with hearing loss 

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:

叶欣 

研究负责人:

何平 

Applicant:

Xin Ye 

Study leader:

Ping He 

申请注册联系人电话:

Applicant telephone:

+86 18813198597 

研究负责人电话:

Study leader's telephone:

+86 13911160537 

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:

yexinxin@pku.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

phe@pku.edu.cn 

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:

北京市海淀区学院路38号树华楼 

研究负责人通讯地址:

北京市海淀区学院路38号树华楼 

Applicant address:

Shuhua Building, 38 Xueyuan Road, Haidian District, Beijing, China 

Study leader's address:

Shuhua Building, 38 Xueyuan Road, Haidian District, Beijing, 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:

北京大学中国卫生发展研究中心 

Applicant's institution:

PKU China Center for Health Development Studies 

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:

IRB00001052-19046 

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:

北京大学生物医学伦理委员会 

Name of the ethic committee:

Peking University Biomedical Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

主任委员 

Contact Name of the ethic committee:

Director of the Committee 

伦理委员会联系地址:

北京市海淀区学院路38号 

Contact Address of the ethic committee:

38 Xueyuan Road, Haidian District, Beijing, China 

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:

北京大学 

Primary sponsor:

Peking University 

研究实施负责(组长)单位地址:

北京市海淀区学院路38号树华楼 

Primary sponsor's address:

Shuhua Building, 38 Xueyuan Road, Haidian District, Beijing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京大学

具体地址:

北京市海淀区学院路38号树华楼

Institution
hospital:

Peking University

Address:

PKU China Center for Health Development Studies

经费或物资来源:

国家自然科学基金 

Source(s) of funding:

Natural Science Foundation of China 

研究疾病:

听力障碍 

Target disease:

Hearing Loss 

研究疾病代码:

 

Target disease code:

 

研究类型:

卫生服务研究 

Study type:

Health services reaserch 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

本研究的总目的是研究以社区为基础的康复服务干预对听力障碍人群生命质量的影响,为制定适应我国听障人群特点的听力康复干预策略提供依据。具体目的包括: (1)确定助听器干预对改善成人听力损失患者的生活质量是否有效; (2) 确定助听器治疗是否具有成本效益,包括改善与健康相关的生活质量;减少住院和门诊次数;恢复生产力等。 

Objectives of Study:

The main purpose of this study is to explore the impact of community-based rehabilitation interventions on quality of life among people with hearing loss, so as to provide basis for the formulation of hearing rehabilitation intervention strategies adapted to the people with hearing loss in China. Specific objectives include the following: (1) determine whether hearing aids intervention is effective in improving the quality of life in adults with hearing loss; (2) determine whether hearing aids treatment is cost-effective, including improving the health-related quality of life; decreasing inpatient and outpatient visits; and recovering productivity. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1)16岁及以上人群; 2)临床诊断有听力障碍,并需要佩戴助听器; 3) 研究期间在本地; 4) 社区居住; 5)中文流利。 

Inclusion criteria

1. Age 16 years old and above; 2. Diagnosed with some degree of hearing loss and are required to wear a hearing aid; 3. Plans to stay in the geographic area for study duration; 4. Community-dwelling; 5. Fluent Chinese speaker. 

排除标准:

1)无读写能力; 2)有认知、心理、语言或行动障碍; 3)自报过去1年使用过助听器; 4)不愿意每天佩戴助听器; 5)有使用助听器的医疗禁忌(如耳漏); 6)双耳有无法治愈的传导性听力损失,相邻两个或以上频率的气骨间隙>15dB。 

Exclusion criteria:

1. Inability to read or write; 2. Cognitive, mental, language or movement disability diagnosis; 3. Self-reported use of a hearing aid in the past 1 year; 4. Unwilling to wear hearing aids on daily basis; 5. Medical contraindication to use of hearing aids (e.g., draining ear); 6. Conductive hearing loss with air-bone gap >15 dB in two or more contiguous frequencies in both ears that cannot be resolved. 

研究实施时间:

Study execute time:

From2019-07-01To 2020-08-01 

征募观察对象时间:

Recruiting time:

From2019-07-01To 2019-08-01 

干预措施:

Interventions:

组别:

Case series

样本量:

464

Group:

Case series

Sample size:

干预措施:

验配并佩戴助听器

干预措施代码:

Intervention:

Fitting and wearing a hearing aid

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

山东 

市(区县):

 

Country:

China 

Province:

Shandong 

City:

 

单位(医院):

山东省临沂市 

单位级别:

 

Institution
hospital:

Linyi City, Shandong Province  

Level of the institution:

 

测量指标:

Outcomes:

指标中文名:

生命质量

指标类型:

主要指标 

Outcome:

Quality of Life

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

认知功能

指标类型:

次要指标 

Outcome:

Cognitive Function

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抑郁

指标类型:

次要指标 

Outcome:

Depressive Symptoms

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生命质量的各个维度

指标类型:

次要指标 

Outcome:

Sub-dimensions of 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:

身体活动能力

指标类型:

次要指标 

Outcome:

Activities of Daily Living

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

工具性身体活动能力

指标类型:

次要指标 

Outcome:

Instrumental Activities of Daily Living

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

慢性病

指标类型:

次要指标 

Outcome:

Chronic Diseases

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

社会支持

指标类型:

次要指标 

Outcome:

Social Support

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院

指标类型:

次要指标 

Outcome:

Hospitalization

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

跌倒

指标类型:

次要指标 

Outcome:

Fall

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

直接医疗成本

指标类型:

次要指标 

Outcome:

Direct Medical Costs

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

间接医疗成本

指标类型:

次要指标 

Outcome:

Indirect Medical Costs

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生产力损失

指标类型:

次要指标 

Outcome:

Loss of Productivity

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 16 years
最大 Max age 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):

不参与数据收集或分析的研究人员将使用随机序列生成器(http://www.random.org)将参与者随机分配到治疗组或对照组。

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

A researcher who is not involved in data collection or analysis will use a random sequence generator (http://www.random.org) to allocate participants in a random sequence to the treatment or control group.

盲法:

Blinding:

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

2022年1月公开;方式:申请公开

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

Share in Jan. 2022; Method: application

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:

每个受试者通过调查问卷采集数据,并被赋予唯一编码。数据录入采用相应的数据库系统双人双机录入。调查问卷在按要求完成后,按编号的顺序归档保存,并填有检索目录等,以备查考。电子数据文件包括数据库、检查程序、分析程序、分析结果、编码本和说明文件等,应分类保存,并有多个备份保存于不同磁盘或记录介质上,以防止损坏。

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

The data of each subject is collected through a questionnaire and is given a unique code. Data entry adopts the corresponding database system of double machine entry. After questionnaires are completed, they will be filed and saved in the order of number with the index for reference. Electronic data files, including databases, inspection procedures, analysis procedures, analysis results, coding and documentation, should be classified and saved, and there are multiple backups saved on different disks or recording media to prevent damage.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-07-26
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