Condition category
Circulatory System
Date applied
12/10/2012
Date assigned
19/10/2012
Last edited
05/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cardiovascular disease (CVD, disease of the heart and/or blood vessels) remains one of the main causes of death worldwide. One of the main factors contributing to CVD is raised blood pressure (hypertension), which is responsible for 5 in 10 deaths from coronary heart disease and 6 in 10 deaths from stroke. China has more than 160 million hypertensive patients, and the death rate for stroke is 4-6 times higher than Japan and the USA, while the amount of stroke and hypertension sufferers is far higher in rural areas (country) compared with urban areas (cities). In 2010, an initial study was conducted in two township hospitals of Zhejiang Province, China to understand the latest situation of CVD control and explore the feasibility of a program to lower the risk of CVD. Based on the feedback of this study, we propose to develop and test a package of cardiovascular risk reduction programs in Zhejiang China. The aim of this study is to explore the effectiveness and cost-effectiveness of a comprehensive CVD risk reduction program.

Who can participate?
Adults aged 50-74 years who have high blood pressure and live in the study area.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group continue to receive standard care for the duration of the study. Those in the second group take part in the CVD risk reduction program. This involves being prescribed a combination of drugs, including anti-hypertensives (drugs which lower blood pressure), low dose aspirin (Which thins the blood and prevents blood clots, lowering the risk of stroke) and a statin (which lowers cholesterol). Participants also receive support for taking their medication properly, attending appointments and making healthy lifestyle changes; and health education (including advice on smoking cessation, reduction of salt, sugar and oil in their diet, and physical exercise). The number of participants to have a CVD event (such as heart attack or stroke) is collected from Zhejiang provincial CVD surveillance system and double checked by interviewing patients at 12, 24 and 36 months. A sampling survey is also conducted at the start of the study and then after 12, 24 and 36 months to find out more about the patients' background, lifestyle and health.

What are the possible benefits and risks of participating?
Participants may benefit from a lower risk of developing CVD. Risks of participating are very low as the doses of drugs used will be modified on an individual basis. Any negative side effects of the drugs will be closely monitored by family doctors and village doctors.

Where is the study run from?
All township hospitals in 3 counties of Zhejiang province, apart from the hosptial that took part in the pilot study (China)

When is the study starting and how long is it expected to run for?
March 2012 to December 2017

Who is funding the study?
1. Comdis Health Services Delivery Research Consortium (UK)
2. Zhejiang Provincial Centre for Disease Control and Prevention (China)

Who is the main contact?
Professor Xiaolin Wei
xiaolin.wei@utoronto.ca

Trial website

Contact information

Type

Scientific

Primary contact

Prof Xiaolin Wei

ORCID ID

Contact details

Dalla Lana School of Public Health
University of Toronto
582-155 College Street
Toronto
M5T 3M7
Canada
+1 416 978 2020
xiaolin.wei@utoronto.ca

Type

Scientific

Additional contact

Dr Min Yu

ORCID ID

Contact details

No. 3399
Binsheng Road
Binjiang District
Hangzhou
310051
China
+86 0571 87115005
myu@cdc.zj.cn

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Cardiovascular disease risk reduction in China: a pilot and clustered randomized controlled trial in Zhejiang

Acronym

Study hypothesis

This systematic cardiovascular disease (CVD) risk reduction programme can reduce CVD events of the population in the intervention group compared with the usual care; the programme is cost effective, friendly to implement and scale up.

Ethics approval

1. University of Leeds Research Ethics Committee, 08/10/2012, ref: HSLTLM/12/010
2. Ethics Committee of Zhejiang Provincial Centre for Disease Control and Prevention, 18/06/2012

Study design

Prospective open-labeled cluster randomised controlled trial with blinded data analysis

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cardiovascular diseases

Intervention

Interventions as of 29/07/2016:
1. Prescribing a combination of drugs: anti-hypertensives, low dose aspirin and a statin;
2. Adherence support on drug compliance, attendance at appointments and healthy lifestyle change;
3. Health education: advice on smoking cessation, reduction of salt, sugar and oil in their diet, and physical exercise.

Previous interventions as of 06/12/2012:
1. Prescribing a combination of drugs: anti-hypertensives, low dose aspirin and a statin
2. Adherence support for drug compliance, attendance and healthy lifestyle change
3. Health Education: smoking cessation, salt, sugar and oil reduction
4. Community-based health intervention:
4.1. Banners and chalked messages
4.2. Peer education by residents with CVD risk
5. Implementation strategies, embedded within the primary care delivery system
The intervention will be designed as job descriptions of family doctors and implemented within the primary care delivery system in Zhejiang China

Previous interventions until 06/12/2012:
1. Health Education: smoking cessation, salt, sugar and oil reduction
2. Proven Drugs: anti-hypertensive's, low dose aspirin, folic acid and a statin
3. Adherence support for drug compliance, attendance and healthy lifestyle change
4. Implementation strategies, embedded within the primary care delivery system
The intervention will be designed as job descriptions of family doctors in the rural areas and implemented within the primary care delivery system in rural Zhejiang China

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Current primary outcome measure as of 06/12/2012:
The major CVD event rates of the residents in study areas

Previous primary outcome measure until 06/12/2012:
The percentage of end events in CVD morbidity and mortality

Secondary outcome measures

Current secondary outcome measures as of 29/07/2016:
1. Mean systolic and diastolic blood pressures of participants
2. Time to the first reported CVD event, mortality, and morbidity of CVD events during the trial period of 36 months
3. Mean change in glycated hemoglobin (HbA1c)
4. Mean change in serum TC and low density lipoprotein
5. Adherence to booked appointments, using the denominator of all participants registered, including defaulters
6. Self-reported adherence to drugs and healthy lifestyle change, for example, smoking cessation rates (for participants who smoke at randomization, the percentage who smoke less than one cigarette a week at 24 months after randomization)
7. Cost-effectiveness
8. Feasibility measures

Previous secondary outcome measures until 06/12/2012:
1. Mean systolic and diastolic blood pressure
2. CVD risk scores
3. Prescription rate of intervention drugs
4. Serum total cholesterol, low density lipid cholesterol (LDL)
5. Smoking cessation rates
6. Adherence to booked appointments and self-reported adherence to healthy lifestyle change and drugs

Overall trial start date

01/03/2012

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Inclusion criteria as of 29/07/2016:
Township hospitals:
1. Have family doctors who provide care according to the essential public health tasks requested by the government and who agree to follow the allocated treatment
2. Are willing to participate in the trial or pilot study

High CVD risk subjects:
1. Adults aged 50-74 years who have provided informed consent
2. Have been diagnosed as hypertension with a calculated 10-year CVD risk of 20% or higher, or have a recorded medical history of diabetes
3. Hold permanent residency in the study area

Previous inclusion criteria as of 06/12/2012:
Township hospitals:
1. Have family doctors who provide care according to the essential public health tasks requested by the government and who agree to follow the allocated treatment
2. Are willing to participate in the trial or pilot study

High CVD risk subjects:
1. Adults aged 60 years and above who have provided informed consent
2. Hold permanent residency in the study area
3. Have a calculated 10-year CVD risk of 20% or higher
4. Have a recorded medical history of diabetes, hyperlipidaemia, coronary heart disease, ischaemic or haemorrhagic cerebro-vascular disease, or peripheral vascular disease.

Previous inclusion criteria until 06/12/2012:
Township hospitals:
1. Located in rural Zhejiang
2. Have family doctors who provide care according to the essential public health tasks requested by the government and who agree to follow the allocated treatment
3. Are willing to participate in the trial or pilot study

High CVD risk subjects:
1. Adults aged 40-74 years who have provided informed consent
2. Hold permanent residency in the study area
3. Have a calculated 10-year CVD risk of 20% or higher, including those having a recorded medical history of hypertension (>140/90)
4. Diabetes, hyperlipidaemia, coronary heart disease, ischaemic or haemorrhagiccerebro-vascular disease, or peripheral vascular disease, or those without CVD symptoms.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30,000

Participant exclusion criteria

Current exclusion criteria as of 06/12/2012:
1. People with known mental illnesses or other severe diseases or disabilities which mean they cannot communicate with township doctors well or regularly
2. Those not living in the community or will move away in the next two years
3. People who have shown serious adverse effects to the recommended drugs
4. Patients who decline to participate in the trial will be excluded

Previous exclusion criteria until 06/12/2012:
1. People with known mental illnesses or other severe diseases or disabilities which mean they cannot communicate with township doctors well or regularly
2. Those not living in the community or will move away in the next three years after recruitment
3. People who have shown serious adverse effects to the recommended drugs
4. Pregnant or breastfeeding women
5. Patients who decline to participate in the trial will be excluded

Recruitment start date

01/09/2013

Recruitment end date

31/05/2014

Locations

Countries of recruitment

China

Trial participating centre

Dongguan community health center
No.5 Hospital Road Dongguan Street Shangyu District
Shaoxing
312352
China

Trial participating centre

Gaibei Township Hospital
Sihe Village Gaibei Town Shangyu District
Shaoxing
312369
China

Trial participating centre

Tangpu Township Hospital
Xin Street Yangpu Town Shangyu District
Shaoxing
312364
China

Trial participating centre

Changtang Township Hospital
No.37 Changtangshang Street Changtang Town Shangyu District
Shaoxing
312352
China

Trial participating centre

Zhangzhen Township Hospital
No.30 Huayuan Road Zhangzhen Town Shangyu District
Shaoxing
312363
China

Trial participating centre

Fenghui Township Hospital
Dongmen Community Fenghui Town Shangyu District
Shaoxing
312361
China

Trial participating centre

Yonghe Township Hospital
Yonghe village Shangyu District
Shaoxing
312371
China

Trial participating centre

Caoe Community Health Center
No.301 Lianfeng Road Shangyu District
Shaoxing
312352
China

Trial participating centre

Lingnan Township Hospital
Fengshuping Village Daoxu Town Shangyu District
Shaoxing
312379
China

Trial participating centre

Dingzhai Township Hospital
No.111 Xiaxi Road Shangzhai Town Dingzhai County Shangyu District
Shaoxing
312373
China

Trial participating centre

Xiaoyue Township Hospital
No.134 Yuedong Road Xiaoyue Town Shangyu District
Shaoxing
312367
China

Trial participating centre

Chenxi Township Hospital
Damiao,Chenxi County Shangyu District
Shaoxing
312362
China

Trial participating centre

Shangpu Township Hospital
.Shangpu Village Shangpu Town Shangyu District
Shaoxing
312375
China

Trial participating centre

Lianghu Township Hospital
Lianghu Nerghborhood Committee Lianghu Town Shangyu District
Shaoxing
312399
China

Trial participating centre

Songxia Township Hospital
No.328 Baisong Road Songxia Town Shangyu District
Shaoxing
312365
China

Trial participating centre

Xietang Township Hospital
Jinsheng Street Donglian Village Xietang Town Shangyu District
Shaoxing
312369
China

Trial participating centre

Baiguan Community Health Center
No.137 Mid Renmin Road Baiguan Street Shangyu District
Shaoxing
312399
China

Trial participating centre

Yiting Township Hospital
Xinyiting Village Yiting Town Shangyu District
Shaoxing
312353
China

Trial participating centre

Xiaguan Township Hospital
No.28 Shuren Road Xiaguan Town Shangyu District
Shaoxing
312351
China

Trial participating centre

Sanjie Township Central Hospital
No.60 Qingchun Road Sanjie Town Shengzhou
Shaoxing
312452
China

Trial participating centre

Tongyuan Township Hospital
Gangxia Village Tongyuan County Shengzhou
Shaoxing
312471
China

Trial participating centre

Xiawang Township Hospital
No.1 Fupai Road Xiawang Village Xiawang Town Shengzhou
Shaoxing
312454
China

Trial participating centre

Sanjiang Community Health Center
No.32 Shangtang South Road Sanjiang Street Shengzhou
Shaoxing
312499
China

Trial participating centre

Shihuang Township Hospital
No.1 Zhenxi Road Shihuang Town Shengzhou
Shaoxing
312471
China

Trial participating centre

Shanhu Community Health Center
No.23 Donghou Street Shengzhou
Shaoxing
312432
China

Trial participating centre

Xianyan Township Hospital
Xianyan Village Xianyan Town Shengzhou
Shaoxing
312459
China

Trial participating centre

Lushan Community Health Center
No.143 Changan Road Shengzhou
Shaoxing
312499
China

Trial participating centre

Gulai Township Hospital
No.43 Wenwei Road Shengzhou
Shaoxing
312472
China

Trial participating centre

Beizhang Township Hospital
Beizhang Village Beizhang Town Shengzhou
Shaoxing
312458
China

Trial participating centre

Pukou Community Health Center
No.3 Wenhua Road Pukou Street Shengzhou
Shaoxing
312451
China

Trial participating centre

Ganlin Township Central Hospital
No.2 Damiao Road Shengzhou
Shaoxing
312464
China

Trial participating centre

Wangyuan Township Hospital
No.289 Wnagyuan Village Wangyuan County Shengzhou
Shaoxing
312472
China

Trial participating centre

Jinting Township Hospital
Jinxi Village Jinting Town Shengzhou
Shaoxing
312458
China

Trial participating centre

Guimen Township Hospital
Guimen Village Guimen County Shengzhou
Shaoxing
312466
China

Trial participating centre

Zhuxi Township Hospital
Zhuxi Village Zhuxi County Shengzhou
Shaoxing
312472
China

Trial participating centre

Linan Township Hospital
Xiaye Village Linan County Shengzhou
Shaoxing
312465
China

Trial participating centre

Huangyi Township Central Hospital
Huangze Town Shengzhou
Shaoxing
312455
China

Trial participating centre

Yahuang Township Hospital
Yahuang Village Yahuang County Shengzhou
Shaoxing
312471
China

Trial participating centre

Chongren Township Central Hospital
Lingtang Road Chongren Town Shengzhou
Shaoxing
312473
China

Trial participating centre

Changle Township Central Hospital
Changle Town Shengzhou
Shaoxing
312467
China

Trial participating centre

Huangshan Township Hospital
No.291 Xiashi Village Huangshan Town Zhuji
Shaoxing
311809
China

Trial participating centre

Chenzhai Township Hospital
Chen Residence Chenzhai Town Zhuji
Shaoxing
311823
China

Trial participating centre

Zhibu Township Hospital
Zhibu Village Zhibu Town Zhuji
Shaoxing
311827
China

Trial participating centre

Jiangzao Township Hospital
Jiangzao Village Jiangzao Town Zhuji
Shaoxing
311822

Trial participating centre

Zhaojia Township Hospital
Zhaoyi Village Zhaojia Town Zhuji
Shaoxing
311819
China

Trial participating centre

Ruanshi Township Hospital
No.142 Nanbin Road Ruanshi Town Zhuji
Shaoxing
311826
China

Trial participating centre

Wuxie Township Hospital
No.19 Wuxie Road Wuxie Town Zhuji
Shaoxing
311807
China

Trial participating centre

Jiyang Community Health Center
No.98 Zhugong Road Zhuji
Shaoxing
311899
China

Trial participating centre

Lipu Township Hospital
No.102 Shuidong Road Lipu Town Zhuji
Shaoxing
312300
China

Trial participating centre

Paitou Community Health Center
Paitou Town Zhuji
Shaoxing
311825
China

Trial participating centre

Lingbei Township Hospital
No.110 Zhuyuanfang Lingbei Town Zhuji
Shaoxing
311823
China

Trial participating centre

Ciwu Township Hospital
No.13 Xiusong Road Ciwu Town Zhuji
Shaoxing
311815
China

Trial participating centre

Jieting Township Hospital
Jieting Village Jieting Town Zhuji
Shaoxing
311805
China

Trial participating centre

Caota Township Hospital
No.30 Fuzhou East Road Cao Tower Town Zhuji
Shaoxing
311812
China

Trial participating centre

Huandong Community Health Center
No 580 Ji East Road Zhuji
Shaoxing
311899
China

Trial participating centre

Donghe Township Hospital
Dongyi Donghe Town Zhuji
Shaoxing
311833
China

Trial participating centre

Taozhu Community Health Center
No.317 County Road Zhuji
Shaoxing
311899
China

Trial participating centre

Datang Township Hospital
Qingfang North Road Datang Town Zhuji
Shaoxing
311801
China

Trial participating centre

Majian Township Hospital
No.5 Majian Town Zhuji
Shaoxing
311803
China

Trial participating centre

Anhua Township Hospital
Xin Street Development Area Anhua Town Zhuji
Shaoxing
311821

Trial participating centre

Yingdian Community Health Center
No.7 Jiankang Road Yingdianjie Town Zhuji
Shaoxing
311817
China

Trial participating centre

Dongbaihu Township Hospital
Chencai Village East Baihu Town Zhuji
Shaoxing
311818
China

Trial participating centre

Wangjiajing Township Hospital
No.50 Shinan Road Wnagjiajin Town Zhuji
Shaoxing
311813
China

Trial participating centre

Shanxiahu Township Hospital
Licha Road Shanxiahu Town Zhuji
Shaoxing
311804
China

Trial participating centre

Diankou Township Hospital
Diankou Township Hospital No.16 Zhenganxi Road Zhuji
Shaoxing
311835
China

Trial participating centre

Fengqiao Township Hospital
Youyi Plaza Zone Fengqiao Town Zhuji
Shaoxing
311811
China

Trial participating centre

Tongshan Township Hospital
.No.2 Xin Street Tongshan Town Zhuji
Shaoxing
311808
China

Sponsor information

Organisation

University of Leeds

Sponsor details

101 Clarendon Road
Leeds
LS2 9LJ
United Kingdom

Sponsor type

Research organisation

Website

Organisation

Zhejiang Provincial Center for Disease Control

Sponsor details

No. 3399
Binsheng Road
Binjiang District
Hangzhou
310051
China

Sponsor type

Government

Website

http://www.cdc.zj.cn/

Funders

Funder type

University/education

Funder name

Comdis Health Services Delivery Research Consortium

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Zhejiang Provincial Center for Disease Control

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of five papers in in high-impact peer reviewed journals:
1. Baseline evaluation of medication adherence (to be published during the trial)
2. Interim analysis of secondary outcomes (to be published during the trial)
3. Qualitative paper on process evaluation of the trial (to be published about one year after the trial end)
4. Paper on costing study (to be published about one year after the trial end)
5. Paper on final outcomes of the trial (to be published about one year after the trial end)

Intention to publish date

31/12/2017

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24160442

Publication citations

  1. Protocol

    Wei X, Zou G, Gong W, Yin J, Yu Y, Walley J, Zhang Z, King R, Chen K, Chong MK, Zee BC, Liu S, Tang J, Griffiths S, Yu M, Cardiovascular disease risk reduction in rural China: a clustered randomized controlled trial in Zhejiang., Trials, 2013, 14, 354, doi: 10.1186/1745-6215-14-354.

Additional files

Editorial Notes

05/08/2016: The trial participating centres have been added to the record. 26/07/2016: The overall trial end date has been updated from 31/12/2015 to 31/12/2017. The recruitmend dates have been updated from 01/03/2013 - 01/05/2013 to 01/09/2013 - 31/05/2014. In addition, the interventions, outcomes measures and inclusion criteria have been updated. Fianlly, "China Global Health Research and Development" has been removed from the list of study sponsors. 06/12/2012: The following changes were made to the record: 1. The overall trial end date was updated from 01/06/2015 to 31/12/2015 2. The target number of participants was updated from 8000 to 30,000 3. The public title was previously "Risk reduction intervention of cardiovascular disease in rural China" 4. The scientific title was previously "Cardiovascular disease risk reduction in rural China: a pilot and clustered randomized controlled trial in Zhejiang"