Risk reduction intervention of cardiovascular disease in China
| ISRCTN | ISRCTN58988083 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58988083 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/10/2012
- Registration date
- 19/10/2012
- Last edited
- 05/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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
Contact information
Scientific
Dalla Lana School of Public Health, University of Toronto
582-155 College Street
Toronto
M5T 3M7
Canada
| Phone | +1 416 978 2020 |
|---|---|
| xiaolin.wei@utoronto.ca |
Scientific
No. 3399
Binsheng Road
Binjiang District
Hangzhou
310051
China
| Phone | +86 0571 87115005 |
|---|---|
| myu@cdc.zj.cn |
Study information
| Study design | Prospective open-labeled cluster randomised controlled trial with blinded data analysis |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Cardiovascular disease risk reduction in China: a pilot and clustered randomized controlled trial in Zhejiang |
| 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(s) | 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 |
| 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 |
| Primary outcome measure | 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 study start date | 01/03/2012 |
| Overall study end date | 31/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30,000 |
| Total final enrolment | 28130 |
| 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 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
Study participating centres
Dongguan Street
Shangyu District
Shaoxing
312352
China
Gaibei Town
Shangyu District
Shaoxing
312369
China
Yangpu Town
Shangyu District
Shaoxing
312364
China
Changtang Town
Shangyu District
Shaoxing
312352
China
Zhangzhen Town
Shangyu District
Shaoxing
312363
China
Fenghui Town
Shangyu District
Shaoxing
312361
China
Shangyu District
Shaoxing
312371
China
Shangyu District
Shaoxing
312352
China
Daoxu Town
Shangyu District
Shaoxing
312379
China
Shangzhai Town
Dingzhai County
Shangyu District
Shaoxing
312373
China
Xiaoyue Town
Shangyu District
Shaoxing
312367
China
Shangyu District
Shaoxing
312362
China
Shangpu Town
Shangyu District
Shaoxing
312375
China
Lianghu Town
Shangyu District
Shaoxing
312399
China
Songxia Town
Shangyu District
Shaoxing
312365
China
Donglian Village
Xietang Town
Shangyu District
Shaoxing
312369
China
Baiguan Street
Shangyu District
Shaoxing
312399
China
Yiting Town
Shangyu District
Shaoxing
312353
China
Xiaguan Town
Shangyu District
Shaoxing
312351
China
Sanjie Town
Shengzhou
Shaoxing
312452
China
Tongyuan County
Shengzhou
Shaoxing
312471
China
Xiawang Village
Xiawang Town
Shengzhou
Shaoxing
312454
China
Sanjiang Street
Shengzhou
Shaoxing
312499
China
Shihuang Town
Shengzhou
Shaoxing
312471
China
Shengzhou
Shaoxing
312432
China
Xianyan Town
Shengzhou
Shaoxing
312459
China
Shengzhou
Shaoxing
312499
China
Shengzhou
Shaoxing
312472
China
Beizhang Town
Shengzhou
Shaoxing
312458
China
Pukou Street
Shengzhou
Shaoxing
312451
China
Shengzhou
Shaoxing
312464
China
Wangyuan County
Shengzhou
Shaoxing
312472
China
Jinting Town
Shengzhou
Shaoxing
312458
China
Guimen County
Shengzhou
Shaoxing
312466
China
Zhuxi County
Shengzhou
Shaoxing
312472
China
Linan County
Shengzhou
Shaoxing
312465
China
Shengzhou
Shaoxing
312455
China
Yahuang County
Shengzhou
Shaoxing
312471
China
Chongren Town
Shengzhou
Shaoxing
312473
China
Shengzhou
Shaoxing
312467
China
Huangshan Town
Zhuji
Shaoxing
311809
China
Chenzhai Town
Zhuji
Shaoxing
311823
China
Zhibu Town
Zhuji
Shaoxing
311827
China
Jiangzao Town
Zhuji
Shaoxing
311822
China
Zhaojia Town
Zhuji
Shaoxing
311819
China
Ruanshi Town
Zhuji
Shaoxing
311826
China
Wuxie Town
Zhuji
Shaoxing
311807
China
Zhuji
Shaoxing
311899
China
Lipu Town
Zhuji
Shaoxing
312300
China
Zhuji
Shaoxing
311825
China
Lingbei Town
Zhuji
Shaoxing
311823
China
Ciwu Town
Zhuji
Shaoxing
311815
China
Jieting Town
Zhuji
Shaoxing
311805
China
Cao Tower Town
Zhuji
Shaoxing
311812
China
Zhuji
Shaoxing
311899
China
Donghe Town
Zhuji
Shaoxing
311833
China
Zhuji
Shaoxing
311899
China
Datang Town
Zhuji
Shaoxing
311801
China
Zhuji
Shaoxing
311803
China
Anhua Town
Zhuji
Shaoxing
311821
China
Yingdianjie Town
Zhuji
Shaoxing
311817
China
East Baihu Town
Zhuji
Shaoxing
311818
China
Wnagjiajin Town
Zhuji
Shaoxing
311813
China
Shanxiahu Town
Zhuji
Shaoxing
311804
China
No.16 Zhenganxi Road
Zhuji
Shaoxing
311835
China
Fengqiao Town
Zhuji
Shaoxing
311811
China
Tongshan Town
Zhuji
Shaoxing
311808
China
Sponsor information
Research organisation
101 Clarendon Road
Leeds
LS2 9LJ
United Kingdom
| Website | http://www.leeds.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/024mrxd33 |
Government
No. 3399
Binsheng Road
Binjiang District
Hangzhou
310051
China
| Website | http://www.cdc.zj.cn/ |
|---|
Funders
Funder type
University/education
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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) |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 25/10/2013 | Yes | No | |
| Results article | results | 16/08/2017 | 26/02/2021 | Yes | No |
| Results article | 01/07/2021 | 05/07/2021 | Yes | No |
Editorial Notes
05/07/2021: Publication reference added.
26/02/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
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"
