Condition category
Nutritional, Metabolic, Endocrine
Date applied
22/03/2017
Date assigned
04/04/2017
Last edited
24/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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?
Professor 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 measures

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

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

Trial participating centre

Yangzhuang Health Center
223305

Trial participating centre

Xindu Health Center
223302

Trial participating centre

Lingqiao Health Center
223306

Trial participating centre

Zhaoji Health Center
223343

Trial participating centre

Yuanji Health Center
223303

Trial participating centre

Wangxing Health Center
223307

Trial participating centre

Sanshu Health Center
223333

Trial participating centre

Qiqiao Health Center
211302

Trial participating centre

Zhuanqiang Health Center
211305

Trial participating centre

Yangjiang Health Center
211313

Trial participating centre

Dongba Health Center
211301

Trial participating centre

Chunxi Health Center
211399

Trial participating centre

Gubai Health Center
211316

Trial participating centre

Gucheng Health Center
211304

Trial participating centre

Yaxi Health Center
211303

Trial participating centre

Dongxing Health Center
214533

Trial participating centre

Xieqiao Health Center
214513

Trial participating centre

Houhe Health Center
214525

Trial participating centre

Chengnan Health Center
214599

Trial participating centre

Huifeng Health Center
214532

Trial participating centre

Gushan Health Center
214522

Sponsor information

Organisation

Nanjing Medical University

Sponsor details

No. 101 Longmian Ave
Nanjing
211166
China

Sponsor type

University/education

Website

http://english.njmu.edu.cn/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes