ChiCTR2000040453 版本V1.0 版本创建时间2021/03/01 09:33:51 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：

 ChiCTR2000040453 

最近更新日期：

Date of Last Refreshed on：

 2020-11-28 13:08:30 

注册时间：

Date of Registration：

 2020-11-28 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Effectiveness of pharmacist led brief educational intervention for adherence to antibiotics therapy lower respiratory tract infections and unnecessary storage of household antibiotics (EATSA) in post conflicted rural areas of Pakistan: Study protocols for randomized controlled trial

Public title：

Effectiveness of pharmacist led brief educational intervention for adherence to antibiotics therapy lower respiratory tract infections and unnecessary storage of household antibiotics (EATSA) in post conflicted rural areas of Pakistan: Study protocols for randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Effectiveness of pharmacist led brief educational intervention for adherence to antibiotics therapy lower respiratory tract infections and unnecessary storage of household antibiotics

Scientific title：

Effectiveness of pharmacist led brief educational intervention for adherence to antibiotics therapy lower respiratory tract infections and unnecessary storage of household antibiotics

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：

Faiz Ullah Khan 

研究负责人：

Prof Yu Fang 

Applicant：

Faiz Ullah Khan 

Study leader：

Prof Yu Fang 

申请注册联系人电话：

Applicant telephone：

 +92 30 35646227

研究负责人电话：

Study leader's
telephone：

+86 18591970591

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：

 faizkhan@stu.xjtu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 yufang@mail.xjtu.edu.cn

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 https://www.researchgate.net/profile/Faiz_Khan12

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 https://www.researchgate.net/profile/Yu_Fang10

申请注册联系人通讯地址：

Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmacy, Xi'an Jiaotong University, Xi'an, Shaanxi, China

研究负责人通讯地址：

Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmacy, Xi'an Jiaotong University, Xi'an, Shaanxi, China

Applicant address：

Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmacy, Xi'an Jiaotong University, Xi'an, Shaanxi, China

Study leader's address：

Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmacy, Xi'an Jiaotong University, Xi'an, Shaanxi, 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：

西安交通大学

Applicant's institution：

Xi'an Jiaotong University

研究负责人所在单位：

西安交通大学

Affiliation of the Leader：

Xi'an Jiaotong University

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：

 2020-1341

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：

西安交通大学医学部生物医学伦理委员会

Name of the ethic committee：

Biomedical Ethics Committee of Xi'an Jiaotong University

伦理委员会批准日期：

Date of approved by ethic committee：

 2020-11-23 00:00:00

伦理委员会联系人：

陈腾

Contact Name of the ethic committee：

Chen Teng

伦理委员会联系地址：

安交通大学医学部生物医学伦理委员会

Contact Address of the ethic committee：

Biology scientific research ethics approval, Health Science Center, Xi'an Jiaotong University

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：

西安交通大学

Primary sponsor：

Xi'an Jiaotong University

研究实施负责（组长）单位地址：

Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmacy, Xi'an Jiaotong University, Xi'an, Shaanxi, China

Primary sponsor's address：

Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmacy, Xi'an Jiaotong University, Xi'an, Shaanxi, 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)：

陕西

市(区县)：

西安

Country：

China

Province：

Shaanxi

City：

Xi'an

单位(医院)：

西安交通大学

具体地址：

Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmacy

Institution
hospital：

Xi'an Jiaotong University

Address：

Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmacy

经费或物资来源：

西安交通大学

Source(s) of funding：

Xi'an Jiaotong University

研究疾病：

下呼吸道感染  

Target disease：

Lower Respiratory Infections

研究疾病代码：

LRTIs

Target disease code：

LRTIs

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：

随机抽样 

Study design：

Randomly Sampling 

研究目的：

Primary objective; The main objective of the current trial, to test the adherence of treatment for LRTIs in local/rural villages of Swat, Pakistan. The secondary objective; to assess improvement through educating the household consumers about the household storage of antibiotics and to reduce the unnecessary storage of antibiotics at homes.  

Objectives of Study：

Primary objective; The main objective of the current trial, to test the adherence of treatment for LRTIs in local/rural villages of Swat, Pakistan. The secondary objective; to assess improvement through educating the household consumers about the household storage of antibiotics and to reduce the unnecessary storage of antibiotics at homes.

药物成份或治疗方案详述：

Two arms single-blind individual randomized parallel control trial will be conducted along with usual care and intervention care groups. Patients will be equally assigned to receive either pharmacist-led education interventions at community pharmacies and fallow or in a control group. Initial recruitment to assess the patient belief about medications (BMQ) and antibiotics resistance knowledge will be observed through the WHO public awareness surveys questionnaire (PAS-QA). The primary outcome is a combined treatment cure rate and adherence by eight-item Morisky Medication Adherence Scale and pill count, and follow up visits. Secondary outcomes include the household storage of antibiotics, patient disease, and participant's satisfaction and feasibility with the education interventions.  

Description for medicine or protocol of treatment in detail：

Two arms single-blind individual randomized parallel control trial will be conducted along with usual care and intervention care groups. Patients will be equally assigned to receive either pharmacist-led education interventions at community pharmacies and fallow or in a control group. Initial recruitment to assess the patient belief about medications (BMQ) and antibiotics resistance knowledge will be observed through the WHO public awareness surveys questionnaire (PAS-QA). The primary outcome is a combined treatment cure rate and adherence by eight-item Morisky Medication Adherence Scale and pill count, and follow up visits. Secondary outcomes include the household storage of antibiotics, patient disease, and participant's satisfaction and feasibility with the education interventions.  

纳入标准：

Patients reported with LRTIs at the pharmacy initially will screen for the inclusion criteria on full consent. The eligibility criteria for the given study include poor adherence to prescribed antibiotics for LRTIs, adult patients household member (age > 18 years) irrespective of gender who can speak and understand languages; Urdu/Pushto or English. The study population has no other comorbidity and not being a part of or involved in any study/trial related to respiratory tract infections or antibiotics during the past four months. Participants who can attend the visits of trials, others having sight/vision, hearing or cognitive impairments, and unable to answers the questionnaire independently will be excluded.

Inclusion criteria

Patients reported with LRTIs at the pharmacy initially will screen for the inclusion criteria on full consent. The eligibility criteria for the given study include poor adherence to prescribed antibiotics for LRTIs, adult patients household member (age > 18 years) irrespective of gender who can speak and understand languages; Urdu/Pushto or English. The study population has no other comorbidity and not being a part of or involved in any study/trial related to respiratory tract infections or antibiotics during the past four months. Participants who can attend the visits of trials, others having sight/vision, hearing or cognitive impairments, and unable to answers the questionnaire independently will be excluded.

排除标准：

The participants other than the inclusion criteria will be excluded.

Exclusion criteria：

The participants other than the inclusion criteria will be excluded.

研究实施时间：

Study execute time：

从 From 2021-12-15 00:00:00至 To 2021-06-15 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-12-01 00:00:00 至 To 2020-03-15 00:00:00

干预措施：

Interventions：

组别：

1

样本量：

 200

Group：

1

Sample size：

干预措施：

Educational intervention

干预措施代码：

Intervention：

Educational intervention

Intervention code：

组别：

2

样本量：

 200

Group：

2

Sample size：

干预措施：

Usual Care

干预措施代码：

Intervention：

Usual Care

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 陕西 

市(区县)：

 西安 

Country：

China

Province：

Shaanxi

City：

Xi’an

单位(医院)：

 西安交通大学 

单位级别：

 大学 

Institution
hospital：

Xi'an Jiaotong University

Level of the institution：

University

国家：

 巴基斯坦

省(直辖市)：

 Khyber Pakhtunkhwa 

市(区县)：

 Swat 

Country：

Pakistan

Province：

Khyber Pakhtunkhwa

City：

Swat

单位(医院)：

 Saidu Group of Teaching Hospital Swat 

单位级别：

 三级医院 

Institution
hospital：

Saidu Group of Teaching Hospital Swat

Level of the institution：

Tertiary Care Hospital

测量指标：

Outcomes：

指标中文名：

The trial comprises pharmacist-led to deliver educational interventions and combination to improve treatment outcomes for patients with LRTIs.

指标类型：

主要指标

Outcome：

The trial comprises pharmacist-led to deliver educational interventions and combination to improve treatment outcomes for patients with LRTIs.

Type：

Primary indicator

测量时间点：

测量方法：

MMAS-8, BMQ questionaire

Measure time point of outcome：

Measure method：

MMAS-8, BMQ questionaire

指标中文名：

Theory-based approach is effective to reduced household storage of antibiotics.

指标类型：

次要指标

Outcome：

Theory-based approach is effective to reduced household storage of antibiotics.

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 60 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）：

A biostatistician independent/blinded to households and trial size creates a random allocation order while using a computer-based produced random digit number. For every household recruited, sample 1:1 is used to allocate houses into control and interventional groups.

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

A biostatistician independent/blinded to households and trial size creates a random allocation order while using a computer-based produced random digit number. For every household recruited, sample 1:1 is used to allocate houses into control and interventional groups.

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 of the present intervention is impossible, due to its educational nature. Though, to reserve a certain level of blinding to keep and protect the bias sources some measures have been taken. Detailed information related to blinding has been shown in Table 3.

Blinding：

Blinding of the present intervention is impossible, due to its educational nature. Though, to reserve a certain level of blinding to keep and protect the bias sources some measures have been taken. Detailed information related to blinding has been shown in Table 3.

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）：

After trial completion

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

After trial completion

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：

According to the defined protocols for data management and monitoring will be implied to be obtained from a quality, genuine, and guaranteed information. Qualitative community pharmacies data will be completed on paper assessment study booklet with participants assigned codes will be stored at the principal investigator field office every day. The principal investigator will check the data, with all the identified quarries to resolved promptly and in case any discrepancies would resolve by a third data entry person. After creating the electronic files all the data will password protected and only authorized persons will access the database and be backed up every day. Qualitative data will be kept and stored in paper forms in the field office within locked file cabinets. The participant's information will be kept confidential and to maintain qualitative data secrecy. All the data forms will be stored and saved in lock filing cabinets as the trained pharmacists know the intervention’s privacy. The healthcare authorities, trained pharmacists, and field staff will monitor the trail progress on daily basis.

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

According to the defined protocols for data management and monitoring will be implied to be obtained from a quality, genuine, and guaranteed information. Qualitative community pharmacies data will be completed on paper assessment study booklet with participants assigned codes will be stored at the principal investigator field office every day. The principal investigator will check the data, with all the identified quarries to resolved promptly and in case any discrepancies would resolve by a third data entry person. After creating the electronic files all the data will password protected and only authorized persons will access the database and be backed up every day. Qualitative data will be kept and stored in paper forms in the field office within locked file cabinets. The participant's information will be kept confidential and to maintain qualitative data secrecy. All the data forms will be stored and saved in lock filing cabinets as the trained pharmacists know the intervention’s privacy. The healthcare authorities, trained pharmacists, and field staff will monitor the trail progress on daily basis.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2020-11-28 13:08:31