Assessing the effects of an educational intervention for chronic disease management in rural China

ISRCTN ISRCTN13319989
DOI https://doi.org/10.1186/ISRCTN13319989
Secondary identifying numbers No. 71473130
Submission date
22/03/2017
Registration date
04/04/2017
Last edited
03/07/2025
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
China is facing a serious situation with the increasing prevalence of chronic (long-term) diseases. According to the report published by National Health and Family Planning Commission in 2015, 19% of the population in China suffers from different kinds of chronic diseases. Moreover, the country’s previous strategy for chronic disease management has focused on the much more costly hospital care, instead of primary care and self-management in rural areas. High health expenses still prevail, which may also increase the economic burden on patients and influence health care seeking behavior. Hence, new strategies are needed to improve treatment of chronic diseases in rural areas. Currently, different outcomes have been used to test the effects of chronic disease management strategies. Despite an increasing number of studies focusing on type 2 diabetes (T2DM) and high blood pressure (hypertension) management in China, most have been performed in urban areas. Moreover, most researchers test physical outcomes, but other important outcomes such as the patient’s perspective, health care seeking behaviour, and the knowledge of healthcare professionals are ignored. The aim of this study is to improve the care of patients with T2DM and hypertension in rural areas through an educational intervention directed at healthcare professionals, to shift the care of patients with T2DM and hypertension from hospital to primary care services.

Who can participate?
Patients aged 35-75 with T2DM or primary hypertension and health care professionals from the participating counties, townships and village clinics

What does the study involve?
The participating areas are divided into different groups according to economic status and health development, and then two areas are randomly selected from each group: one to the intervention group and one to the control group. Patients in the intervention areas receive services including lectures about self-management strategies, follow-up interviews, physical examination, and special medical services (such as medical treatment, transfer treatment, return visits, and clinical care). The healthcare professionals in the intervention groups are provided with professional development including training lessons, regular meetings, team communications, technical checks, and new performance appraisal. For patients and healthcare professionals in the control areas, current routine health services continue as usual. The patients' blood glucose, blood pressure, health status, satisfaction with health services, health insurance, understanding of diabetes, health seeking behaviour, and out-of-pocket costs of care are assessed before and after the intervention. The health care professionals' knowledge about chronic disease management and their general perceptions about the intervention are assessed before and after the intervention.

What are the possible benefits and risks of participating?
Patients in the intervention areas benefit from receiving information and guidance in issues related to chronic diseases and self-management. Health care professionals who are participating in the intervention may benefit from the possibility of being offered a promotion. Moreover, the intervention contains a performance appraisal, including a bonus and professional development for healthcare professionals. A potential risk for the patients is the leak of information as some sensitive data is collected. In order to reduce the risk of a leak, all members of the research team are asked to sign a confidentiality agreement. There are no risks for healthcare professionals participating in the study.

Where is the study run from?
The study is conducted in three counties in Jiangsu province (Gaochun, Jingjiang, Huaiyin) together with the township health centers and villages clinics in those townships. In total, 22 township health centers are involved in the study. The whole process is led by the research team and coordinated by the local health bureau.

When is the study starting and how long is it expected to run for?
January 2015 to December 2018

Who is funding the study?
The National Natural Science Fund of China

Who is the main contact?
Prof. Dongfu Qian
dqian@njmu.edu.cn

Contact information

Prof Dongfu Qian
Scientific

Nanjing Medical University
No. 101 Longmian Ave
Nanjing
211166
China

ORCiD logoORCID ID 0000-0002-7704-1068
Phone +86 (0)25 8686 2951
Email dqian@njmu.edu.cn

Study information

Study designCluster randomised controlled trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)Community
Study typeOther
Participant information sheet Not available in English, please use the contact details to request a patient information sheet
Scientific titleVertical integrated service model: an educational intervention for chronic disease for patients and healthcare professionals in rural China
Study objectives1. The education-based intervention will have a positive effect on the patients’ physical health and their understanding of their chronic disease.
2. The educational intervention will improve the professionalism and understanding of chronic disease management for local healthcare professionals.
Ethics approval(s)Nanjing Medical University Ethics Committee, 02/08/2015, ref: 300
Health condition(s) or problem(s) studiedOptimising care for adult patients with type 2 diabetes or primary hypertension
InterventionThe project is an interventional study conducted in three counties in Jiangsu Province, China. The selection of intervention and control groups is done by the local (township level) health bureaus. They will firstly divide the townships into different groups according to economic status and health development, and then randomly select two townships (one as intervention, one as control) from each group.

The educational intervention will be conducted by a service team which has been assembled by the local health bureau in each county.

Patients in the intervention group will receive the following services:
1. Lectures mainly focusing on prevention and self-management strategies for chronic disease, nutrition and physical activity, proper health behaviours, and psychological counselling
2. Periodical follow-up interviews along with an annual physical examination
3. Special medical service, including helping patients with medical treatment, transfer treatment, return visit, and clinical care, etc

Healthcare professionals in the intervention group will receive the following services:
1. Training lessons for the village GPs.
2. Regular meetings to discuss their work progress
3. Team communications about analysing patients’ conditions or formulating personalized therapeutic regimens
4. Technical checks to inspect the patients’ disease monitoring schemes, prevention and treatment plans
5. New performance appraisal for doctors and nurses containing two parts:
5.1. Bonus for those who do well in the project
5.2. Opportunities for professional development for outstanding doctors or nurses

For patients and healthcare professionals in the control areas, current routine health services will continue as usual and there will be no service team.

The intervention will last for one year in two counties and for two years in the third county. During this period, the county level and township level health bureaus will be responsible for administrating the whole process. The research team will conduct periodical quality controls.
Intervention typeBehavioural
Primary outcome measureFor patients:
1. Physiological measures (blood glucose/glycosylated haemoglobin (HbAlC)/blood pressure), collected during the medical examination
2. Health status, measured using the generic health-related quality of life instrument EQ-5D
3. Satisfaction with health services, health insurance, understanding of diabetes, health seeking behaviour and patients’ out-of-pocket costs of care, assessed using a questionnaire
Measured at baseline and follow-up (12 months after start of intervention)
Secondary outcome measuresFor healthcare professionals:
1. Knowledge about the current epidemiological situation of chronic disease in their own village, assessed through a knowledge test
2. The general procedure of diagnosing and registering chronic disease, assessed through in-depth interviews
3. The chronic disease management situation before and after intervention, assessed through in-depth interviews
4. Their general perceptions about the intervention, assessed through in-depth interviews
Measured at baseline and follow-up (12 months after start of intervention)
Overall study start date01/01/2015
Completion date30/12/2018

Eligibility

Participant type(s)Patient
Age groupMixed
SexBoth
Target number of participants1,980
Key inclusion criteria1. Diagnosed with type 2 diabetes (FBG ≥7.0 mmol/l, and/or 2hPBG ≥11.1 mmol/l) or primary hypertension (SBP ≥140mmHg, and/or DBP ≥90mmHg) and has been on medications for more than one month
2. Aged 35-75
3. Lived in the intervention/control areas for more than two years (no records of moving within the last year)
4. Has no plan of moving from the intervention/control areas or no long-term travelling plans (more than one year)
5.Has his/her records on the chronic disease management information system of township health center or village clinic, and has accepted the chronic disease service provided by township health center or village clinic
6. Willing to participate in this project and has a preferable compliance, cognition and receptivity
Key exclusion criteria1. Has serious complications of diabetes or hypertension (for example, diabetic foot III/IV, diabetic retinopathy IV or higher, diabetic nephropathy IV/V, hypertension III)
2. Has been diagnosed with secondary hypertension
3. Has been diagnosed with any other serious disease, such as terminal stages of cancer, AIDS, etc
4. Pregnant women or patients with psychiatric problems
Date of first enrolment01/01/2015
Date of final enrolment01/02/2015

Locations

Countries of recruitment

  • China

Study participating centres

Nanchengji Health Center
223341
China
Yangzhuang Health Center
223305
China
Xindu Health Center
223302
China
Lingqiao Health Center
223306
China
Zhaoji Health Center
223343
China
Yuanji Health Center
223303
China
Wangxing Health Center
223307
China
Sanshu Health Center
223333
China
Qiqiao Health Center
211302
China
Zhuanqiang Health Center
211305
China
Yangjiang Health Center
211313
China
Dongba Health Center
211301
China
Chunxi Health Center
211399
China
Gubai Health Center
211316
China
Gucheng Health Center
211304
China
Yaxi Health Center
211303
China
Dongxing Health Center
214533
China
Xieqiao Health Center
214513
China
Houhe Health Center
214525
China
Chengnan Health Center
214599
China
Huifeng Health Center
214532
China
Gushan Health Center
214522
China

Sponsor information

Nanjing Medical University
University/education

No. 101 Longmian Ave
Nanjing
211166
China

Website http://english.njmu.edu.cn/
ROR logo "ROR" https://ror.org/059gcgy73

Funders

Funder type

Government

National Natural Science Fund of China

No information available

Results and Publications

Intention to publish date30/12/2019
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publications in high-impact peer reviewed journals as well as Chinese core journals (in total 6-10 papers). Moreover, 4-8 policy advisory reports to different Chinese governmental departments as well as 4 research reports will be provided.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Dongfu Qian (dqian@njmu.edu.cn)

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 20/07/2018 Yes No
Results article results 26/07/2019 31/07/2019 Yes No
Results article 20/03/2020 06/06/2023 Yes No
Results article 02/07/2025 03/07/2025 Yes No

Editorial Notes

03/07/2025: Publication reference added.
06/06/2023: Publication reference added.
31/07/2019: Publication reference added.
07/02/2019: Publication reference added.