Guangdong Uptake of Surgery Trial

Study Overview
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Brief Summary
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The purpose of this study is: To determine whether an educational intervention designed based on studies in the area is effective in increasing acceptance of surgery and presentation to the hospital, when adjusting for a number of potential determinants of service uptake; To assess short-term impact of the educational intervention on knowledge about cataract and attitudes toward locally-available surgical services.

Detailed Description
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China is home to the 18% of the world's blind people, an estimated 6.6 million. In China, cataract is the leading cause of blindness. In Guangdong, current counseling measures for patients diagnosed with cataract are minimal and often lack adequate descriptions of what cataract is, what causes cataract, and benefits/risks of surgery. A counseling session for cataract patients and family members, conducted by a trained nurse during outreach screening, may increase subsequent attendance at pre-operative examination, acceptance of cataract surgery, and attendance at follow-up examinations. An integral part of this counseling is a short movie consisting of testimony from a former cataract patient who underwent surgery (pseudophakic motivator). The use of pseudophakic motivators have been shown to be effective in increasing surgical uptake. In addition, a previously validated Barriers Questionnaire will be used to assess predictors of of hospital attendance, surgery acceptance, and follow-up attendance in the categories of cost, transportation, knowledge, and concerns about quality.

Official Title
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The Effect of Counseling in Cataract Screening: Guangdong Uptake of Surgery Trial

Conditions
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Cataract

Intervention / Treatment
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* Behavioral: Video and counseling for cataract patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: thought by the examiner to have age-related or myopic cataract in one or both eyes pinhole-corrected visual acuity less than or equal to 6/18. Exclusion Criteria: traumatic cataract inability to give informed consent due to dementia or other reasons.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Counseling<br>Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session. | Behavioral: Video and counseling for cataract patients<br>* Intervention includes: (1) a 5-10 min video consisting of testimony from a previous cataract patient and a doctor; (2) a 10-15 min pre-operative counseling session with a trained nurse, and (3) a 5 min post-operative counseling session with a trained nurse.<br>|
| No Intervention: Non-counseling<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decision to Undergo Cataract Surgery (Surgery Acceptance) | Measured as a percentage of subjects who decide to undergo cataract surgery within 6 months after screening (positive) out of total subjects. | within 6 months after screening examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attendance at Hospital for Pre-operative Examination | Measured as a percentage of people who presented to the hospital within 6 months after screening (positive) out of total subjects. | within 6 months after screening examination | 
| Knowledge That Cataract Can be Treated | Measured as a percentage of subjects who correctly answer the question in a questionnaire. | Assessed during day of screening examination | 
| Belief That Surgery Will be Painful | Measured as a percentage of subjects who agree with the statement in a questionnaire. | Assessed during day of screening examination | 
| Belief That Vision Will Improve a Lot Following Surgery | Measured as a percentage of subjects who agree with the statement in a questionnaire. | Assessed during day of screening examination | 
| Belief That Surgeons at the Hospital Are Highly Skilled | Measured as a percentage of subjects who agree with the statement in a questionnaire. | Assessed during day of screening examination | 
| Belief That Doctors and Nurses at the Hospital Have Very Good Attitudes | Measured as a percentage of subjects who agree with the statement in a questionnaire. | Assessed during day of screening examination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cataract, counseling, surgical uptake, follow-up