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The effectiveness of pictorial Chronic Obstructive Pulmonary Disease (COPD) action plan on reducing hospital readmissions in elderly patients with COPD in Hong Kong: A randomized controlled trial
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注册号：

Registration number：

 ChiCTR1900026235 

最近更新日期：

Date of Last Refreshed on：

 2019-09-28 08:53:08 

注册时间：

Date of Registration：

 2019-09-28 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

The effectiveness of pictorial Chronic Obstructive Pulmonary Disease (COPD) action plan on reducing hospital readmissions in elderly patients with COPD in Hong Kong: A randomized controlled trial

Public title：

The effectiveness of pictorial Chronic Obstructive Pulmonary Disease (COPD) action plan on reducing hospital readmissions in elderly patients with COPD in Hong Kong: A randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

The effectiveness of pictorial Chronic Obstructive Pulmonary Disease (COPD) action plan on reducing hospital readmissions in elderly patients with COPD in Hong Kong: A randomized controlled trial

Scientific title：

The effectiveness of pictorial Chronic Obstructive Pulmonary Disease (COPD) action plan on reducing hospital readmissions in elderly patients with COPD in Hong Kong: A randomized 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：

申请注册联系人：

Ho Choi Yin Cherry 

研究负责人：

Ho Choi Yin Cherry 

Applicant：

Ho Choi Yin Cherry 

Study leader：

Ho Choi Yin Cherry 

申请注册联系人电话：

Applicant telephone：

 +852 60293710

研究负责人电话：

Study leader's
telephone：

+86 60293710

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：

 hocherry1016@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 hocherry1016@gmail.com

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：

中國香港特別行政區新界沙田上水中心5座5樓D層

研究负责人通讯地址：

中國香港特別行政區新界沙田上水中心5座5樓D層

Applicant address：

Flat D, 5/F, Block 5, Sheung Shui Centre, Sheung Shui, N.T., Hong Kong SAR, China

Study leader's address：

Flat D, 5/F, Block 5, Sheung Shui Centre, Sheung Shui, N.T. Hong Kong SAR, 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：

香港聯合醫院護理學校

Applicant's institution：

School of Nursing, Union Hospital

研究负责人所在单位：

香港聯合醫院護理學校

Affiliation of the Leader：

School of Nursing, Union Hospital

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：

 KC/KE-19-0082/ER-1

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：

Research Ethics Commitee

Name of the ethic committee：

Research Ethics Commitee

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-08-21 00:00:00

伦理委员会联系人：

Ms Chim Wai Ping

Contact Name of the ethic committee：

Ms Chim Wai Ping

伦理委员会联系地址：

中國香港特別行政區九龍加士居道30號伊莉莎白女王醫院

Contact Address of the ethic committee：

Queen Elizabeth Hospital, 30 Gascoigne Road, Kowloon, Hong Kong SAR, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 35068151

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 amychim@ha.org.hk

研究实施负责（组长）单位：

香港聯合醫院護理學校

Primary sponsor：

School of Nursing, Union Hospital

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上水中心5座5樓D層

Primary sponsor's address：

Flat D, 5/F, Block 5, Sheung Shui Centre, Sheung Shui, N.T., Hong Kong SAR, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Self

Source(s) of funding：

self-finance

研究疾病：

慢性阻塞性肺疾病  

Target disease：

Chronic Obstructive Pulmonary Disease

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

The objectives of this study are: i. To improve the patients recall of treatment regime; ii. To improve the patients comprehension of treatment regime; iii. To improve the patients health-related quality of life; iv. To improve the patients adherence to action plan; v. To improve the patients symptom control; vi. To reduce the patients unplanned emergency department visits; vii. To reduce the patients unplanned hospital readmissions; viii. To reduce the patients length of unplanned hospital stay; ix. To reduce the patients mortality rate.  

Objectives of Study：

The objectives of this study are: i. To improve the patients recall of treatment regime; ii. To improve the patients comprehension of treatment regime; iii. To improve the patients health-related quality of life; iv. To improve the patients adherence to action plan; v. To improve the patients symptom control; vi. To reduce the patients unplanned emergency department visits; vii. To reduce the patients unplanned hospital readmissions; viii. To reduce the patients length of unplanned hospital stay; ix. To reduce the patients mortality rate.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

i. Are discharged to residential care homes;
ii. Have chronic lung disease other than COPD (e.g. pneumoconiosis, pulmonary fibrosis).

Exclusion criteria：

i. Are discharged to residential care homes;
ii. Have chronic lung disease other than COPD (e.g. pneumoconiosis, pulmonary fibrosis).






iii. Have psychiatric problems;


iv. Are already using a self-management plan;


v. Are cognitive impaired (Abbreviated Mental Test Score <6);


vi. Are recruited in the Validation of illustration of Pictorial Action Plan;


vii. Illiterate.

研究实施时间：

Study execute time：

从 From 2019-10-02 00:00:00至 To 2021-04-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2019-10-01 00:00:00 至 To 2019-11-30 00:00:00

干预措施：

Interventions：

组别：

Experimental group

样本量：

 84

Group：

Experimental group

Sample size：

干预措施：

pictorial Chronic Obstructive Pulmonary Disease (COPD) action plan

干预措施代码：

Intervention：

pictorial Chronic Obstructive Pulmonary Disease (COPD) action plan

Intervention code：

组别：

Control group

样本量：

 84

Group：

Control group

Sample size：

干预措施：

written action plan

干预措施代码：

Intervention：

written action plan

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

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)：

 聯合醫院 

单位级别：

  

Institution
hospital：

United Christina Hospital

Level of the institution：

测量指标：

Outcomes：

指标中文名：

Recall and Comprehension

指标类型：

次要指标

Outcome：

Recall and Comprehension

Type：

Secondary indicator

测量时间点：

Post-test and follow-up test (6 months)

测量方法：

Validated Questionnaires

Measure time point of outcome：

Post-test and follow-up test (6 months)

Measure method：

Validated Questionnaires

指标中文名：

Average Length of Hospital Stay

指标类型：

次要指标

Outcome：

Average Length of Hospital Stay

Type：

Secondary indicator

测量时间点：

post 6 months

测量方法：

Computerized record

Measure time point of outcome：

post 6 months

Measure method：

Computerized record

指标中文名：

Adherence to inhalation technique

指标类型：

次要指标

Outcome：

Adherence to inhalation technique

Type：

Secondary indicator

测量时间点：

immediate after intervention

测量方法：

validated checklist

Measure time point of outcome：

immediate after intervention

Measure method：

validated checklist

指标中文名：

COPD assessment Test

指标类型：

次要指标

Outcome：

COPD assessment Test

Type：

Secondary indicator

测量时间点：

post test and follow up at 6 months

测量方法：

validated questionnaire

Measure time point of outcome：

post test and follow up at 6 months

Measure method：

validated questionnaire

指标中文名：

Unplanned emergency department visit

指标类型：

次要指标

Outcome：

Unplanned emergency department visit

Type：

Secondary indicator

测量时间点：

post 6 months

测量方法：

computerized record

Measure time point of outcome：

post 6 months

Measure method：

computerized record

指标中文名：

Hospital Readmission

指标类型：

主要指标

Outcome：

Hospital Readmission

Type：

Primary indicator

测量时间点：

6 months after intervention

测量方法：

computerized record

Measure time point of outcome：

6 months after intervention

Measure method：

computerized record

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 65 岁 years
最大 Max age 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）：

A statistician using computer generates random codes and block randomization will be adopted by a ratio 1:1.

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

A statistician using computer generates random codes and block randomization will be adopted by a ratio 1:1.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Doule Blind. Patients will be blinded and the outcomes will be evaluated by research assistant. Then the researcher can be blinded.

Blinding：

Doule Blind. Patients will be blinded and the outcomes will be evaluated by research assistant. Then the researcher can be blinded.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

publication

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

publication

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：

A research team member will take an envelope contain grouping identifier (I or C) to allocate recruited subjects to either intervention or control group. Intervention group will receive pictorial COPD action plan and control group received written action plan. Action plan will be individualized according to discharge prescription by the physician. Education will be provided to both groups by research team members. Everything in the both groups will be the same except the intervention group will receive a pictorial action plan while control group will receive a written action plan. Data will be collected on the date of being discharged at the interview room in the ward of the study hospital and at follow up after 6 months by phone interview. Subjects’ socio-demographic and clinical data will be collected by custom-designed questionnaire, subjects’ clinical charts and computerized hospital records at baseline. The data include age, gender, marital status, living arrangement, The forced expiratory volume-one second (FEV1), the volume of air that can forcibly be blown out in first 1 second after full inspiration, will be measured by spirometry which will be provided by respiratory team in the study hospital. Health literacy assessment will be also performed by Chinese Health Literacy Scale for Chronic Care(CHLCC) at baseline. It is developed based on Bloom’s Taxonomy. It could be completed in average 7 minutes. It have good internal reliability (Cronbach’s = 0.91) and good test-retest reliability (intraclass correlation coefficient= 0.77). Recall and comprehension will be assessed by validated questionnaire. Post-test will be conducted immediately after intervention and at 6-month by follow up. Adherence to action plan will be assessed by validated checklists. Post- test will be conducted immediately after intervention and at 6-month follow up. Health-related quality of life and symptoms control will be assessed by the COPD Assessment Test(CAT) at baseline and 6-month follow up. Hospital services utilization in past 6 months, including unplanned hospital readmissions, unplanned emergency department visits and the length of unplanned hospital, will be obtained by computerized hospital records and self-reporting at baseline and 6-month follow-up.

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

A research team member will take an envelope contain grouping identifier (I or C) to allocate recruited subjects to either intervention or control group. Intervention group will receive pictorial COPD action plan and control group received written action plan. Action plan will be individualized according to discharge prescription by the physician. Education will be provided to both groups by research team members. Everything in the both groups will be the same except the intervention group will receive a pictorial action plan while control group will receive a written action plan. Data will be collected on the date of being discharged at the interview room in the ward of the study hospital and at follow up after 6 months by phone interview. Subjects’ socio-demographic and clinical data will be collected by custom-designed questionnaire, subjects’ clinical charts and computerized hospital records at baseline. The data include age, gender, marital status, living arrangement, The forced expiratory volume-one second (FEV1), the volume of air that can forcibly be blown out in first 1 second after full inspiration, will be measured by spirometry which will be provided by respiratory team in the study hospital. Health literacy assessment will be also performed by Chinese Health Literacy Scale for Chronic Care(CHLCC) at baseline. It is developed based on Bloom’s Taxonomy. It could be completed in average 7 minutes. It have good internal reliability (Cronbach’s = 0.91) and good test-retest reliability (intraclass correlation coefficient= 0.77). Recall and comprehension will be assessed by validated questionnaire. Post-test will be conducted immediately after intervention and at 6-month by follow up. Adherence to action plan will be assessed by validated checklists. Post- test will be conducted immediately after intervention and at 6-month follow up. Health-related quality of life and symptoms control will be assessed by the COPD Assessment Test(CAT) at baseline and 6-month follow up. Hospital services utilization in past 6 months, including unplanned hospital readmissions, unplanned emergency department visits and the length of unplanned hospital, will be obtained by computerized hospital records and self-reporting at baseline and 6-month follow-up.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2019-09-28 08:53:08
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