Research on the construction and effect evaluation of health literacy intervention measures for Yi nationality residents in Liangshan Prefecture
| ISRCTN | ISRCTN11299863 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11299863 |
- Submission date
- 26/05/2022
- Registration date
- 01/06/2022
- Last edited
- 15/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Improving urban and rural residents' health literacy helps to improve their ability to identify and solve their own health problems. It is an important strategy and measure to improve people's health and one of the main indicators of the Healthy China 2030 Plan. However, at present, the health literacy level of Residents in Liangshan Yi Autonomous Prefecture is still at a low level (only 11.62%), and the health literacy level of residents in some Yi autonomous counties is only about 1%. Improving the health literacy of the Yi nationality residents is a key issue to be urgently solved. The main aim of this study is to propose a set of health literacy interventions for Yi nationality residents in Liangshan Yi Autonomous Prefecture and improve the health literacy of local residents. This study also hopes to propose a set of electronic questionnaire quality control systems and artificial intelligence-based quality control methods to provide a tool reference for future field interventions and investigations in underdeveloped areas.
Who can participate?
Yi residents aged 15-64 years old who have lived in Meigu County and Yanyuan County of Liangshan Yi Autonomous Prefecture for more than half a year, whose native place is Liangshan Yi Autonomous Prefecture
What does the study involve?
Interventions are proposed to include key steps such as project preparation, core mobilization, internal radiation and competitive incentives, with Contracted Family Doctor Services as a comparison. Project preparation refers to organizing experts and responsible persons of health education and chronic non-communicable disease prevention to establish advisory committees, providing health knowledge support, health skills support, information technology support, financial support, etc for the sponsors of each family branch. Core mobilization refers to the recruitment, screening and training of various sponsors. Internal radiation refers to health literacy education, including nutrition education, carried out by the sponsor of each branch to other members of the branch using health literacy pamphlets in accordance with the operation manual. Finally, to inspect and test the actual mastery of health literacy in the subjects, the traditional Yi festival activities such as "Sai Shuo" are used to carry out health literacy knowledge competitions in families and branches on a regular basis. The residents' health literacy level in the Healthy Liangshan Performance Evaluation Index is taken as the main outcome. Questionnaires and physical examination information will be collected at the 1st, 3rd, 6th, 9th and 12th months.
What are the possible benefits and risks of participating?
Residents participating in the study can improve their health literacy through the interventions. However, since the study will last for a long time, there may be a risk of disclosure of personal information. In view of this, the researchers will use strict data management measures. They will not collect individually identifiable data and will replace it with numbers to reduce the risk of disclosure, so there will be no risk to residents’ privacy.
Where is the study run from?
West China School of Public Health and West China Fourth Hospital, Sichuan University (China)
When is the study starting and how long is it expected to run for?
January 2020 to May 2023
Who is funding the study?
1. National Natural Science Foundation of China (China)
2. Chongqing Science and Technology Program (China)
3. Liangshan Community Diagnosis Project (China)
Who is the main contact?
Dr Tao Zhang
statzhangtao@scu.edu.cn
Contact information
Scientific
Department of Epidemiology and Health Statistics
West China School of Public Health and West China Fourth Hospital, Sichuan University
Chengdu
610041
China
| Phone | +86 (0)15908141271 |
|---|---|
| scdxzhangtao@163.com |
Public
Department of Epidemiology and Health Statistics
West China School of Public Health and West China Fourth Hospital, Sichuan University
Chengdu
610041
China
| Phone | +86 (0)15908141271 |
|---|---|
| scdxzhangtao@163.com |
Study information
| Study design | Stepped-wedge cluster randomized trial using an open cohort design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Study on the construction and effect evaluation of health literacy intervention measures for Yi nationality residents in Liangshan Prefecture based on the joint model of "Contracted Family Doctor Services + Family Branch System": research of stepped-wedge cluster randomized controlled trial |
| Study objectives | Study objectives: 1. Based on the traditional ICCC framework and the unique Family Branch System of Liangshan Yi Autonomous Prefecture, propose a set of health literacy interventions for the Yi nationality residents in Liangshan Yi Autonomous Prefecture to improve the health literacy of local residents. 2. Propose a set of electronic questionnaire quality control system construction and artificial intelligence-based quality control method to provide a tool reference for future field intervention and investigation in underdeveloped areas. 3. Improve the statistical analysis method of stepped-wedge design, and propose a hybrid model-based main hierarchical causal inference method to solve the common non-compliance problems in the stepped-wedge design, which will not only improve the accuracy of the intervention effect evaluation, but also promote the development of statistical methodology for stepped-wedge studies. |
| Ethics approval(s) | Approved 26/05/2022, Ethics Committee of West China Fourth Hospital and West China School of Public Health, Sichuan University (No. 16, section 3, Renmin South Road, Wuhou District, Chengdu, Sichuan, China; +86 (0)28 85508845; hxgwsylunli@163.com), ref: Gwll2022068 |
| Health condition(s) or problem(s) studied | Residents’ health literacy |
| Intervention | Taking residents aged 15-64 years in Liangshan Yi Autonomous Prefecture as the research object, based on the joint model of "Contracted Family Doctor Services + Family Branch System", members of family branches are recruited as the intervention group for the health literacy intervention, and the routine "Contracted Family Doctor Services" in Liangshan Yi Autonomous Prefecture are used as the control measure. Meigu County and Yanyuan County of Liangshan Yi Autonomous Prefecture carry out various forms of health education activities for residents' health literacy every year, and this study will appropriately enrich health literacy promotion programs in normal management work. In addition, the study areas have inconvenient transportation, low overall education level and relatively closed information. Therefore, it is difficult for subjects to perceive the transition from the non-intervention state to the intervention state, which ensures the implementation of a blinded method for subjects to some extent. The designed interventions are intended to include key steps such as project preparation, core mobilization, internal radiation and competitive incentives. Project preparation refers to organizing experts and responsible persons of health education and chronic non-communicable disease prevention to establish advisory committees, providing health knowledge support, health skills support, information technology support, financial support, etc for the sponsors of each family branch. Core mobilization refers to the recruitment, screening and training of various sponsors. Internal radiation refers to health literacy education, including nutrition education, carried out by the sponsor of each branch to other members of the branch using health literacy pamphlets in accordance with the operation manual. Finally, to inspect and test the actual mastery of health literacy in the subjects, the traditional Yi festival activities such as "Sai Shuo" are used to carry out health literacy knowledge competitions in families and branches on a regular basis. R 4.0.5 is used to generate random numbers, and a unique number will be assigned to the family branches recruited in Meigu county and Yanyuan County respectively to generate sampling framework. Using simple random sampling, six branches are selected from Meigu county and Yanyuan County respectively, and divided into four groups by independent complete randomization. In the next stage, 50 random samples of eligible individuals will be selected in each branch according to gender and age stratification, and the sampling work will be carried out by statistical members of the research group. The intervention will be initiated 3 months after the start of the trial in groups 1 and 2, and 6 months after the start of the trial in groups 3 and 4. The study period is 1 year, from May 2022 to May 2023, with follow-up for the last 3 months. |
| Intervention type | Other |
| Primary outcome measure | Health literacy of residents measured using the 2020 Residents Health Literacy Monitoring Questionnaire at the 1st, 3rd, 6th, 9th and 12th months of the experiment |
| Secondary outcome measures | Measured at the 1st, 3rd, 6th, 9th and 12th months of the experiment: 1. Smoking and drinking status of the residents measured by questionnaire 2. Height and weight measured using a height and weight measurement instrument 3. Blood pressure measured using a blood pressure meter 4. Blood sugar measured by venous blood drawing |
| Overall study start date | 20/01/2020 |
| Completion date | 25/05/2023 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | This study needs 12 clusters, which means 12 experimental family branches, 50 subjects in each cluster, 600 subjects in total. |
| Key inclusion criteria | 1. Native place is Liangshan Yi Autonomous Prefecture 2. Have lived in Meigu County or Yanyuan County of Liangshan Yi Autonomous Prefecture for more than half a year 3. Yi nationality residents living in compact communities aged 15-64 years 4. Voluntarily participate in the project |
| Key exclusion criteria | 1. Pregnant women 2. People with serious disabilities who cannot be examined 3. Mental patients |
| Date of first enrolment | 01/06/2022 |
| Date of final enrolment | 26/02/2023 |
Locations
Countries of recruitment
- China
Study participating centre
615700
China
Sponsor information
Government
83 Shuangqing Road
Haidian District
Beijing
100085
China
| Phone | +86 (0)62327195 |
|---|---|
| fmr@nsfc.gov.cn | |
| Website | http://www.scst.gov.cn/ |
"ROR" |
https://ror.org/01h0zpd94 |
Government
Productivity Building
2 Xingai Avenue
Yubei District
Chongqing
401147
China
| Phone | +86 (0)23 67605835 |
|---|---|
| kjxc@kjj.cq.gov.cn |
Hospital/treatment centre
Second Section
Hangkong Avenue
Xichang
615000
China
| Phone | +86 (0)13881506956 |
|---|---|
| liaoqiang411@163.com |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
- Location
- China
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication(s) in high-impact peer-reviewed journal(s) |
| IPD sharing plan | The datasets analyzed during the current study will be available from Tao Zhang (statzhangtao@scu.edu.cn) on reasonable request. Upon reasonable request by other researchers, raw data (Excel file) will be made available after the publication of the scientific reports and with the agreement of all program board members. Data can be used for scientific peer-review or meta-analytic procedures. Data will be collected with participants' informed consent and would be fully anonymised. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 13/08/2022 | 15/08/2022 | Yes | No |
Editorial Notes
15/08/2022: Publication reference added.
31/05/2022: Trial's existence confirmed by the Liangshan Prefecture Center for Disease Control and Prevention.
