Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Prof Dongfu Qian
ORCID ID
http://orcid.org/0000-0002-7704-1068
Contact details
Nanjing Medical University
No. 101 Longmian Ave
Nanjing
211166
China
+86 (0)25 8686 2951
dqian@njmu.edu.cn
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
No. 71473130
Study information
Scientific title
Vertical integrated service model: an educational intervention for chronic disease for patients and healthcare professionals in rural China
Acronym
Study hypothesis
1. 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
Nanjing Medical University Ethics Committee, 02/08/2015, ref: 300
Study design
Cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Community
Trial type
Other
Patient information sheet
Not available in English, please use the contact details to request a patient information sheet
Condition
Optimising care for adult patients with type 2 diabetes or primary hypertension
Intervention
The 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 type
Behavioural
Phase
Drug names
Primary outcome measure
For 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 measures
For 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 trial start date
01/01/2015
Overall trial end date
30/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
1,980
Participant exclusion criteria
1. 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
Recruitment start date
01/01/2015
Recruitment end date
01/02/2015
Locations
Countries of recruitment
China
Trial participating centre
Nanchengji Health Center
223341
China
Trial participating centre
Yangzhuang Health Center
223305
China
Trial participating centre
Xindu Health Center
223302
China
Trial participating centre
Lingqiao Health Center
223306
China
Trial participating centre
Zhaoji Health Center
223343
China
Trial participating centre
Yuanji Health Center
223303
China
Trial participating centre
Wangxing Health Center
223307
China
Trial participating centre
Sanshu Health Center
223333
China
Trial participating centre
Qiqiao Health Center
211302
China
Trial participating centre
Zhuanqiang Health Center
211305
China
Trial participating centre
Yangjiang Health Center
211313
China
Trial participating centre
Dongba Health Center
211301
China
Trial participating centre
Chunxi Health Center
211399
China
Trial participating centre
Gubai Health Center
211316
China
Trial participating centre
Gucheng Health Center
211304
China
Trial participating centre
Yaxi Health Center
211303
China
Trial participating centre
Dongxing Health Center
214533
China
Trial participating centre
Xieqiao Health Center
214513
China
Trial participating centre
Houhe Health Center
214525
China
Trial participating centre
Chengnan Health Center
214599
China
Trial participating centre
Huifeng Health Center
214532
China
Trial participating centre
Gushan Health Center
214522
China
Sponsor information
Organisation
Nanjing Medical University
Sponsor details
No. 101 Longmian Ave
Nanjing
211166
China
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Natural Science Fund of China
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned 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 plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Dongfu Qian (dqian@njmu.edu.cn)
Intention to publish date
30/12/2019
Participant level data
Available on request
Basic results (scientific)
Publication list
2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30029653
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31357408 (added 31/07/2019)