Effective and low-cost management of cardiovascular risks at primary healthcare settings in Anhui, China.
| ISRCTN | ISRCTN87887485 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87887485 |
| Sponsor | National Natural Science Foundation of China |
| Funder | National Natural Science Foundation of China |
- Submission date
- 27/01/2026
- Registration date
- 28/01/2026
- Last edited
- 28/01/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Cardiovascular diseases are a major and growing health problem, causing illness, deaths, and high healthcare costs. In China, primary healthcare clinics play an important role in preventing and managing these conditions, but they face challenges such as limited training, lack of support, and few incentives. This study aims to test whether a new, cost‑effective system can help clinicians provide better care and help patients manage their health more effectively.
Who can participate?
People can take part if they live permanently in the communities served by the 32 selected clinics in Anhui Province, are aged 18 or older, and have been diagnosed with hypertension, diabetes, high cholesterol, or any cardiovascular disease. All full‑time clinicians responsible for chronic disease care in these clinics will also participate.
What does the study involve?
The study will include 32 clinics. Half will continue with their usual care, and the other half will use the new care approach. Participants in both groups will have health assessments at the start of the study, after 12 months, and after 24 months.
In clinics using the new approach, clinicians will follow a step‑by‑step system to decide what support each patient needs. This may include advice on diet, exercise, stopping smoking, reducing alcohol, managing stress, and monitoring blood pressure, blood sugar, cholesterol, or weight. Patients may also receive personalised leaflets to support self‑management at home.
What are the possible benefits and risks of participating?
Participants may benefit from receiving more personalised support to manage their health, which could help improve their cardiovascular risk factors. There are no known major risks. Some people may find the extra assessments or lifestyle discussions time‑consuming, but these are expected to be minimal.
Where is the study run from?
The study is being carried out in Anhui Province, China.
When is the study starting and how long is it expected to run for?
The study will run from March 2026 to March 2028.
Who is funding the study?
The study is funded by the National Natural Science Foundation of China.
Who is the main contact?
Associate Professor Xingrong Shen
Email: xinrongshen@sina.com
Contact information
Public, Scientific, Principal investigator
81 Meishan Road
Hefei
230032
China
 ORCID ID |
0000-0002-9708-9659 |
|---|---|
| Phone | +86 0551-65116395 |
| xinrongshen@sina.com |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Open (masking not used) | |
| Control | Active | |
| Assignment | Parallel | |
| Purpose | Prevention | |
| Scientific title | Cost-effectiveness-oriented management(CEOM) of cardiovascular risks at primary healthcare settings in Anhui, China | |
| Study objectives | The current trial aims to test the efficacy of an integrated and Cost-effectiveness-oriented intervention to overcome the main existing problems and thus improve CVD risk and harm management at primary healthcare settings in Anhui, China. | |
| Ethics approval(s) |
Approved 07/03/2023, Anhui Medical University Biomedical Ethics Committee (Anhui Medical University, 81 Meishan Road, Hefei, Anhui, 230032, China; +86 0551-65161053; renzhenhua@ahmu.edu.cn), ref: 83230358 | |
| Health condition(s) or problem(s) studied | Cardiovascular disease | |
| Intervention | Participants randomized to the intervention arm will implement an integrated and Cost-effectiveness-oriented management (CEOM) of CVD risks and harms using algorithm or model assisted: standardization of clinical diagnosis and treatment procedures according to guidelines and expert consensus; and promotion of personalized self-management based on the changing health and behavioral conditions of the individual participants under concern. Randomization will be conducted after the baseline but before the intervention by an independent statistician using the "Sealed Envelope" web-based system. He/she will employ a stratified randomization method by county. More specifically, he/she will randomly assign the two selected village clinics from each county in a 1:1 ratio to either the intervention or control group. While blinding of village clinicians and patients is not feasible due to the nature of the intervention, the statisticians will be kept blinded throughout the analysis process. | |
| Intervention type | Behavioural | |
| Primary outcome measure(s) |
Incremental Cost-effectiveness ratio (ICER) calculated using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) instrument and cost-utility survey data at baseline and at 12 and 24 months after baseline. | |
| Key secondary outcome measure(s) |
1. Patient knowledge, attitude, and practice (KAP) regarding nutrition/diet, physical activity, smoking and alcohol abstinence, emotional and sleep problems, self‑monitoring, health service use, and treatment adherence is measured using a structured questionnaire at baseline, 12 months, and 24 months | |
| Completion date | 30/03/2028 |
Eligibility
| Participant type(s) | Health professional, Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | Clinicians: 1. Hold a valid medical license and work full-time at the participating clinics 2. Are directly responsible for the routine management and clinical care of CVD-related cases 3. Agree to participate in the study and sign the informed consent form Patients: 1. Age ≧18 years 2. Have clinical diagnosis of CVD-related conditions (including hypertension, diabetes, coronary heart diseases, stroke sequelae, etc.) 3. Are permanent residents (living in the site villages for >6 months a year) 4. Are willing and able to participate and complete the pre-set surveys (e.g., EQ-5D-5L); 5) have signed the informed consent form |
| Key exclusion criteria | Clinicians 1. Will retire or plan to leave their current practice within the next 24 months 2. Are participants in other interventional studies which may confound the results of the current trial Patients: 1. Plan to move out of the selected site villages within the next 24 months 2. Are participants in other interventions that may confound the results of the current trial |
| Date of first enrolment | 01/03/2026 |
| Date of final enrolment | 30/03/2026 |
Locations
Countries of recruitment
- China
Study participating centre
Hefei
230032
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan |
Editorial Notes
27/01/2026: Trial's existence confirmed by Anhui Medical University Biomedical Ethics Committee.
