Promoting universal eye health coverage through integrating eye care into primary health care system in rural Xinjiang, China
| ISRCTN | ISRCTN94275003 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94275003 |
- Submission date
- 16/05/2025
- Registration date
- 19/05/2025
- Last edited
- 16/05/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Eye Diseases
Plain English Summary
Background and study aims
Vision impairment and blindness are significant health challenges in rural areas of Xinjiang, China, where access to eye care is limited. This study aims to test a new approach, the iREACHES model, which combines health system strengthening (HSS) and behavioral economics (BE) strategies to improve access to eye care services. We will evaluate whether the model helps more people use primary eye care (PEC) services and get timely referrals for specialist care when needed.
Who can participate?
Adults aged 18 years or older who live in the rural communities served by the participating township health centers (THCs) in Shawan County and Jinghe County, Xinjiang, and have lived there for at least six months. Participants must be able to give informed consent and must not have received eye treatment in the two weeks prior to the study.
What does the study involve?
Participants will receive improved eye care services at their local health centers. The intervention includes better training for healthcare providers, community education about eye health, and more effective referral pathways to specialist care when necessary. Some participants will receive the new eye care model earlier than others as the program is gradually introduced.
What are the possible benefits and risks of participating?
The potential benefits include better access to eye care services, improved vision-related quality of life, and greater awareness of eye health. There is a minimal risk of discomfort during eye examinations or sharing personal health information, but all procedures will follow ethical guidelines to ensure participant safety.
Where is the study run from?
The study will be conducted in township health centers (THCs) in Shawan County and Jinghe County, located in rural Xinjiang, China.
When is the study starting and how long is it expected to run for?
September 2024 to May 2026
Who is funding the study?
The study is funded by the Peking University (China)
Who is the main contact?
For more information, please contact the Principal Investigator at Peking University.
Xiaochen Ma, Assistant Professor
xma@hsc.pku.edu.cn
Contact information
Principal Investigator
38 Xueyuan Road, Haidian District
Beijing
100191
China
| Phone | +(86)010-82805706 |
|---|---|
| xma@hsc.pku.edu.cn |
Public, Scientific
38 Xueyuan Road, Haidian District
Beijing
100191
China
| Phone | +(86)18868113171 |
|---|---|
| dongxd@hsc.pku.edu.cn |
Study information
| Study design | Multicenter interventional stepped-wedge cluster randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Community |
| Study type | Diagnostic, Prevention, Screening, Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Promoting universal eye health coverage through integrating eye care into primary health care in rural Xinjiang, China: a stepped wedge cluster randomized trial and macroeconomic modelling study |
| Study acronym | iREACHES |
| Study hypothesis | The primary hypothesis of this study is that the iREACHES model, which integrates health system strengthening (HSS) and behavioral economics (BE) strategies, will significantly improve: (1) Utilization of primary eye care (PEC) services at township health centers (THCs) in rural Xinjiang compared to usual care; and (2) Referral efficiency to secondary eye care (SEC) at county hospitals for conditions requiring specialized treatment. |
| Ethics approval(s) |
1. Approved 12/05/2025, Peking University Institutional Review Board Office (38 Xueyuan Road, Haidian District, Beijing, 100191, China; +(86)010-82805751; llwyh@bjmu.edu.cn), ref: IRB00001052-25041 2. Approved 05/12/2024, Medical Ethics Management Committee of Jinghe County People's Hospital (No. 19 Jianshe Road, Jinghe County, Bortala Mongol Autonomous Prefecture, Xinjiang, 833300, China; +(86)0909-5332366; 1214995717@qq.com), ref: JHIRB2024001 3. Approved 31/12/2024, Medical Ethics Committee of Shawan People's Hospital (62 Century Avenue South Road, Shawan City, Tacheng Prefecture, Xinjiang, 834700, China; +(86)0993-6011362; 15981701234@163.com), ref: SWIRB2024001 |
| Condition | The study focuses on improving access to primary eye care (PEC) and referral efficiency for secondary eye care (SEC) to address vision impairment and blindness among rural residents in Xinjiang, China. |
| Intervention | The study will implement the iREACHES model, which integrates Health System Strengthening (HSS) and Behavioral Economics (BE) strategies, in 16 township health centers (THCs) across two rural counties in Xinjiang. The intervention will include: Systemic Integration of Eye Care: Incorporating eye disease screening into routine health examinations and strengthening referral pathways. Capacity Building: Training healthcare providers through a "train-the-trainer" model and equipping THCs with essential diagnostic tools. Strengthening Continuity of Care: Enhancing the coordination between primary and secondary eye care within the County-level Tight Medical Alliances (CTMAs). Improving Eye Health Literacy: Conducting community education campaigns and employing behavioral nudges to encourage eye care utilization. Participants will be randomized at the cluster level using a stepped-wedge design, with one cluster transitioning from control to intervention every three months. Usual care will serve as the control, comprising routine health services without the iREACHES-specific interventions. The duration of the intervention will be 12 months, and data collection will take place at three-month intervals to monitor primary and secondary outcomes. |
| Intervention type | Mixed |
| Primary outcome measure | 1. Utilization of PEC services at township health centers is measured using healthcare facility records at baseline and 12 months post-intervention 2. Number of appropriate referrals to secondary eye care at county hospitals is measured using referral logs and hospital health information systems at baseline and 12 months post-intervention |
| Secondary outcome measures | 1. Availability of trained personnel, diagnostic tools, and screening capabilities at PHC level is measured using facility audits and healthcare provider surveys at baseline and 12 months post-intervention 2. Community knowledge about eye health is measured using structured interviews and community surveys at baseline and 12 months post-intervention 3. Vision-related quality of life is measured using the NEI VFQ-25 at baseline and 12 months post-intervention 4. General health-related quality of life is measured using the EQ-5D-5L at baseline and 12 months post-intervention |
| Overall study start date | 01/09/2024 |
| Overall study end date | 31/05/2026 |
Eligibility
| Participant type(s) | Resident |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | The target number of participants for this multicenter stepped-wedge cluster randomized controlled trial (SW-CRT) is 1,120 individuals, with 14 clusters (township health centers) and 80 participants per cluster. |
| Participant inclusion criteria | 1. Adults aged 18 years or older 2. Residents of rural communities served by the participating township health centers (THCs) in Shawan County and Jinghe County, Xinjiang 3. Individuals who have resided in the local community for at least six months prior to the study 4. Individuals who are willing and able to provide informed consent 5. Individuals who have not received ophthalmological treatment within two weeks prior to the study 6. Individuals without severe cognitive impairments or other conditions that would hinder their ability to provide informed consent |
| Participant exclusion criteria | 1. Individuals who have received ophthalmological treatment within two weeks prior to the study 2. Individuals with severe cognitive impairments that hinder the ability to provide informed consent 3. Individuals with medical conditions that may interfere with participation or outcome assessment 4. Individuals who do not reside in the rural areas served by the selected township health centers (THCs) in Shawan County or Jinghe County, Xinjiang 5. Individuals under 18 years of age 6. Individuals who have not lived in the local community for at least six months prior to the study |
| Recruitment start date | 20/05/2025 |
| Recruitment end date | 20/05/2026 |
Locations
Countries of recruitment
- China
Study participating centres
Beijing
100191
China
Bortala Mongol Autonomous Prefecture, Xinjiang
833300
China
Tacheng Prefecture, Xinjiang
834700
China
Sponsor information
University/education
38 Xueyuan Road, Haidian District
Beijing
100191
China
| Phone | +(86)010-82805684 |
|---|---|
| cchds@pku.edu.cn | |
| Website | https://www.pku.edu.cn |
"ROR" |
https://ror.org/02v51f717 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- 北京大学, PKU
- Location
- China
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analyzed during the current study will be available upon request from the Principal Investigator at Peking University. Requests for data access should be directed to Xiaochen Ma, Assistant Professor China Center for Health Development Studies, Peking University, Beijing, China. xma@hsc.pku.edu.cn. Data Types to Be Shared The shared data will include de-identified individual participant data (IPD) related to eye care service utilization, referral efficiency, and vision-related quality of life (VRQoL), collected during the trial. Availability Timeline Data will be available starting six months after publication of the primary results and will remain accessible for a period of five years. Access Criteria and Mechanism Data will be shared with researchers affiliated with academic or public health institutions who provide a methodologically sound proposal. Data access will be granted for the purpose of replicating results, conducting meta-analyses, or exploring secondary research questions related to rural eye care and health systems strengthening. Ethical and Legal Considerations The data will be anonymized to protect participant confidentiality, and data sharing will comply with ethical guidelines and data protection regulations. Participants will provide informed consent, including their agreement to data sharing under these conditions. Mechanism for Data Access Approved researchers will be required to sign a data-sharing agreement outlining the terms of use, including prohibition of data re-identification and commitment to publish findings in peer-reviewed journals. |
Editorial Notes
16/05/2025: Trial's existence confirmed by Peking University Institutional Review Board Office.
