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Correcting Myopia Among Secondary School Children to Increase Academic High School Attendance Rates in Rural Communities (SWISH)

Primary Purpose

Refractive Errors

Status
Not yet recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Spectacles
Sponsored by
Queen's University, Belfast
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Errors focused on measuring Refractive error, Myopia, Academic high school attendance, Education attainment, Spectacle wear compliance, Mental health well-being, Progression of shortsightedness

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Year 1 and 2 classes (likely age 12-15 years) at the recruited schools
  • Have uncorrected (without glasses) visual acuity of ≤6/12 in either eye;
  • Refractive error meets cut-offs shown to be associated with significantly greater improvement in visual acuity when corrected (myopia ≤-0.75 diopters (D), hyperopia ≥2.00 D, or astigmatism (non-spherical refractive error) ≥1.00 D);
  • Visual acuity can be improved to >6/12 in both eyes with glasses.

Exclusion Criteria:

  • Presence of visually-significant ocular condition besides refractive error

Sites / Locations

  • Ningxia University
  • Centre for Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Children at Intervention schools will receive free spectacles of a design they select, based on the child's measured refractive power and dispensed at school by the study optometrist. Additionally, teachers (but not children) in eligible classes will be informed that if 80% spectacle compliance as measured across three separate unannounced inspections was achieved, they will be given an incentive of an conditional cash transfer. The cash transfer will be deposited into the teacher's bank accounts directly.

Children at Control schools will receive a glasses prescription and letter to the parents informing them of the refractive status of their child, with free glasses provided only at the end of the trial. No teacher incentive will be offered. Service offered to the Control group exceeds standard care, in that no school-based programs of vision screening and refraction currently exist in the study area, or in most of rural China.

Outcomes

Primary Outcome Measures

Academic high school attendance
Proportion of children who continue to academic high school as opposed to vocational high school or no additional schooling, assessed by systematically contacting parents, teachers and students to ascertain enrolment status

Secondary Outcome Measures

Compliance with spectacle wear
Actual presence of spectacles on the child's face (rather than having glasses at school) at the time of an unannounced examination.
Mathematics score
Scores at the end of each school year on a study-specific mathematics test, adjusting for baseline score.
Blackboard use
Frequency of blackboard versus textbook use in the major subjects (Maths, Chinese, English) on a questionnaire administered to teachers, and answered as "all", "most", "about half", little" or "none" of teaching.
Cost effectiveness of intervention.
Calculated as ratio of incremental cost to proportion of children who continue to academic high school as opposed to vocational high school or no schooling. Incremental cost is the difference of costs between implementation of intervention and control. Intervention costs will comprise the screening test, glasses (including replacements) and teacher incentives.
Depression and Anxiety
Depression and anxiety score measured with Anxiety Stress Scale (DASS). The score range for depression, anxiety and stress are 0-42, with higher score indicates more severe mental health problems.
Self Esteem
Self-esteem score measured with the Rosenberg Self-esteem Scale. The scores range from 0-30, with higher scores indicate higher self-esteem.
Emotional and behavioral problems
Emotional and behavioral problems score using the Strengths and Difficulties Questionnaire (SDQ), with difficulties score ranges from 0 to 40, Prosocial scale ranges from 0-10, with higher score indicates severe mental health and behavioral problems.
Parent-proxy quality of life
Parent-proxy quality of life will be measured by using Pediatric Quality of Life Inventory™ Generic Core Scales, with scores range from 0-100. The higher score, the better the quality of life
Child self-reported quality of life
Child self-reported quality of life will be measured by using Pediatric Quality of Life Inventory™ Generic Core Scales, with scores range from 0-100. The higher score, the better the quality of life.
Progression of shortsightedness
The length of the eyeball (axial length) will be measured by using a biometry measuring device (A-Scan) after applying a drop of topical anaesthetic (proxymetacaine/proparacaine) in the right eye.

Full Information

First Posted
August 7, 2019
Last Updated
December 3, 2021
Sponsor
Queen's University, Belfast
Collaborators
Zhongshan Ophthalmic Center, Sun Yat-sen University, Stanford University, New England College of Optometry, Clearly, Ningxia Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04077086
Brief Title
Correcting Myopia Among Secondary School Children to Increase Academic High School Attendance Rates in Rural Communities
Acronym
SWISH
Official Title
SWISH (See Well to Stay In ScHool): Randomised Trial of Spectacle Distribution to Secondary School Children With Myopia to Increase Academic High School Attendance Rates in Rural Communities)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University, Belfast
Collaborators
Zhongshan Ophthalmic Center, Sun Yat-sen University, Stanford University, New England College of Optometry, Clearly, Ningxia Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Chinese children are some of the most short-sighted in the world, but only one in five children in poor areas who needs glasses has them. Our team has already shown in other trials that giving children free glasses leads to better grades and that free glasses have a bigger impact on grades than factors like parents' education level and the amount of money a family has. The effect on grades from glasses is greater than from other health services in school, like giving vitamins. Only about one in three children in rural western China goes on to a regular, non-vocational high school. The investigators would like to show the Chinese government strong evidence of what glasses can do to help children continue their education, in order to help convince the government to carry out national programs to provide free glasses for children who need them. Study Plan: The investigators will choose 130 middle schools at random in Ningxia, western China, and all children in Years 1 and 2 (one class each) at each school will go at random into one of two groups: either a group getting free glasses, with support from teachers to push them to wear the glasses ("Intervention") or a group getting just glasses prescriptions ("Control.") The main study outcome will be the proportion of children going on to academic (as opposed to vocational) high school, and the study is powered to detect a 10% difference in this figure between groups.The study will also assess children's test scores, whether they wear their glasses at school, and how often they use blackboards (which disadvantage short-sighted children) vs textbooks to learn from. These other outcomes will help us to better understand the causal pathway between vision and high school attendance. We will also study the total cost of providing glasses glasses and the teacher support to wear them per additional student attending academic high school. The hypothesis of this study is that providing glasses will increase academic high school attendance.
Detailed Description
Research question: Will providing free glasses to myopic rural Chinese students, with a teacher incentive to promote use, increase academic high school attendance? Design: Cluster-randomised controlled trial Rationale: Rural Chinese children have high myopia prevalence, but poor access to glasses. Our previous trials show giving free glasses significantly improves academic performance, with greater effect size than parental education or family income, equaling or exceeding other classroom-based medical interventions. Non-vocational (academic) high school attendance is only 30% in rural western China. Strong evidence of educational benefit from glasses is needed to spur adoption of national distribution programs. Methods: Children in Year 1 and 2 (1 class each) at 130 randomly-selected middle schools in Ningxia, western China, will be randomized by school to receive free glasses and a trial-proven teacher-based incentive to promote wear (Intervention) or prescriptions only (Control). The main outcome 2-3 years later will be high school attendance (powered to detect 10% difference between study groups); secondary outcomes of compliance, test scores and use of near versus distance classroom learning aids will elucidate biological plausibility of a causal pathway between myopia correction and learning. Local knowledge and attitudes about myopia and spectacle use and intervention cost-effectiveness will be studied. Statistical methods to be employed in the analysis and justification for the choice of sample size: Adjusted- and unadjusted-comparison of the difference between study groups Of academic high school attendance of mathematics test performance at endline (adjusted for baseline), of observed spectacle wear at un-announced examinations Sample size: Assuming 50% of children will fail vision screening, 70% of these needing glasses, with loss to follow-up=10%, α=0.05, intra-class correlation=0.15, explained variation by covariates=0.40, difference between the groups in the main study outcome=10%, high-school attendance rate in the Control group=30%, a sample size of 130 middle-schools (65 in each group) will provide power=85%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors
Keywords
Refractive error, Myopia, Academic high school attendance, Education attainment, Spectacle wear compliance, Mental health well-being, Progression of shortsightedness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Children in Year 1 and 2 at 130 randomly-selected middle-schools in Ningxia, western China, will be randomized by school to receive free glasses and a teacher-based incentive to promote wear, or prescriptions only.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Study personnel assessing trial outcomes will be masked as to children's study group assignment, which will be simplified by the fact that there will be participants with and without glasses at both Intervention and Control schools. It is not ethical in this setting to provide Control participants with placebo treatment (glasses with zero power lenses), but students, parents and teachers will not be informed of either the overall design of the study or the explicit treatment intervention assignment. Only one school will be selected in each township, minimizing the possibility of cross arm communication and contamination.
Allocation
Randomized
Enrollment
4800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Children at Intervention schools will receive free spectacles of a design they select, based on the child's measured refractive power and dispensed at school by the study optometrist. Additionally, teachers (but not children) in eligible classes will be informed that if 80% spectacle compliance as measured across three separate unannounced inspections was achieved, they will be given an incentive of an conditional cash transfer. The cash transfer will be deposited into the teacher's bank accounts directly.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Children at Control schools will receive a glasses prescription and letter to the parents informing them of the refractive status of their child, with free glasses provided only at the end of the trial. No teacher incentive will be offered. Service offered to the Control group exceeds standard care, in that no school-based programs of vision screening and refraction currently exist in the study area, or in most of rural China.
Intervention Type
Device
Intervention Name(s)
Spectacles
Other Intervention Name(s)
Glasses
Intervention Description
Intervention group children in middle school Years 1 and 2 will receive spectacles at the beginning of the academic year (September 2021). Assuming that the relevant effects of treatment (glasses wear) on the main study outcome are complete once examinations determining high school attendance are finished at the end of Middle School Year 3, Intervention participants will have undergone either 22 months (September 2021 to July 2023 for those recruited in Year 2) or 34 months (September 2021 to July 2024 for those recruited in Year 1) of treatment by the endpoint of the trial.
Primary Outcome Measure Information:
Title
Academic high school attendance
Description
Proportion of children who continue to academic high school as opposed to vocational high school or no additional schooling, assessed by systematically contacting parents, teachers and students to ascertain enrolment status
Time Frame
In September following completion of Year 3 of Middle School. This occurs after 24 months of participant followup for children recruited in middle school Year 2 and after 36 months of participant followup for those recruited in middle school year 1.
Secondary Outcome Measure Information:
Title
Compliance with spectacle wear
Description
Actual presence of spectacles on the child's face (rather than having glasses at school) at the time of an unannounced examination.
Time Frame
After 8, 20 and 32 months of participant followup
Title
Mathematics score
Description
Scores at the end of each school year on a study-specific mathematics test, adjusting for baseline score.
Time Frame
After 8, 20 and 32 months of participant followup)
Title
Blackboard use
Description
Frequency of blackboard versus textbook use in the major subjects (Maths, Chinese, English) on a questionnaire administered to teachers, and answered as "all", "most", "about half", little" or "none" of teaching.
Time Frame
After 20 and 32 months of participant followup
Title
Cost effectiveness of intervention.
Description
Calculated as ratio of incremental cost to proportion of children who continue to academic high school as opposed to vocational high school or no schooling. Incremental cost is the difference of costs between implementation of intervention and control. Intervention costs will comprise the screening test, glasses (including replacements) and teacher incentives.
Time Frame
At study closeout, after 24 months of participant followup for those recruited in middle school Year 2 and 36 months of participant followup for those recruited in Middle School Year 1.
Title
Depression and Anxiety
Description
Depression and anxiety score measured with Anxiety Stress Scale (DASS). The score range for depression, anxiety and stress are 0-42, with higher score indicates more severe mental health problems.
Time Frame
At baseline and12 month post-treatment
Title
Self Esteem
Description
Self-esteem score measured with the Rosenberg Self-esteem Scale. The scores range from 0-30, with higher scores indicate higher self-esteem.
Time Frame
At baseline and12 month post-treatment
Title
Emotional and behavioral problems
Description
Emotional and behavioral problems score using the Strengths and Difficulties Questionnaire (SDQ), with difficulties score ranges from 0 to 40, Prosocial scale ranges from 0-10, with higher score indicates severe mental health and behavioral problems.
Time Frame
At baseline and12 month post-treatment
Title
Parent-proxy quality of life
Description
Parent-proxy quality of life will be measured by using Pediatric Quality of Life Inventory™ Generic Core Scales, with scores range from 0-100. The higher score, the better the quality of life
Time Frame
At baseline and12 month post-treatment
Title
Child self-reported quality of life
Description
Child self-reported quality of life will be measured by using Pediatric Quality of Life Inventory™ Generic Core Scales, with scores range from 0-100. The higher score, the better the quality of life.
Time Frame
At baseline and12 month post-treatment
Title
Progression of shortsightedness
Description
The length of the eyeball (axial length) will be measured by using a biometry measuring device (A-Scan) after applying a drop of topical anaesthetic (proxymetacaine/proparacaine) in the right eye.
Time Frame
At baseline, 12 month and 24 month

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Year 1 and 2 classes (likely age 12-15 years) at the recruited schools Have uncorrected (without glasses) visual acuity of ≤6/12 in either eye; Refractive error meets cut-offs shown to be associated with significantly greater improvement in visual acuity when corrected (myopia ≤-0.75 diopters (D), hyperopia ≥2.00 D, or astigmatism (non-spherical refractive error) ≥1.00 D); Visual acuity can be improved to >6/12 in both eyes with glasses. Exclusion Criteria: Presence of visually-significant ocular condition besides refractive error
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nathan Congdon, MD, MPH
Phone
07748751393
Email
ncongdon1@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Congdon, MD, MPH
Organizational Affiliation
Queen's University, Belfast
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ningxia University
City
Yinchuan
State/Province
Xixia
ZIP/Postal Code
750021
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huiping Zhang, PhD
Phone
+86 13895191039
Email
zhp0329@sina.com
Facility Name
Centre for Public Health
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT12 6BJ
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathan Congdon, MD, MPH
Phone
02890976350
Ext
8929
Email
ncongdon1@gmail.com
First Name & Middle Initial & Last Name & Degree
Smit Gade
Phone
+7023679633
Email
gade@goodbusinesslab.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be made available on the websites of Queen's University Belfast and Stanford University
IPD Sharing Time Frame
Within 6 months of completing data analysis, available for 5 years.
IPD Sharing Access Criteria
Open

Learn more about this trial

Correcting Myopia Among Secondary School Children to Increase Academic High School Attendance Rates in Rural Communities

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