Impact of a Printed Decision Aid on Cataract Surgery Choice
NCT ID: NCT03525015
Last Updated: 2018-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
696 participants
INTERVENTIONAL
2018-05-16
2019-10-30
Brief Summary
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Detailed Description
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We will conduct a randomized controlled trial for cataract patients aged 50-80 years. We will randomly assign participants to either the intervention using a decision aid booklet or the one using a usual cataract booklet. The primary outcome is informed choice (defined as adequate knowledge and consistency between attitudes and intentions) 2 weeks after intervention.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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A decision aid booklet
A decision aid booklet about cataract surgery choice
A decision aid booklet about cataract surgery choice
Potential participants receive a decision aid booklet with information about cataract surgery choice, and outcome data will be gathered using standardized questions in a structured interview after 2 weeks and 1 year.
An usual booklet
An usual booklet about cataract and cataract surgery
An usual booklet about cataract and cataract surgery
Potential participants receive an usual booklet with information about cataract and cataract surgery, and outcome data will be gathered using standardized questions in a structured interview after 2 weeks and 1 year.
Interventions
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A decision aid booklet about cataract surgery choice
Potential participants receive a decision aid booklet with information about cataract surgery choice, and outcome data will be gathered using standardized questions in a structured interview after 2 weeks and 1 year.
An usual booklet about cataract and cataract surgery
Potential participants receive an usual booklet with information about cataract and cataract surgery, and outcome data will be gathered using standardized questions in a structured interview after 2 weeks and 1 year.
Eligibility Criteria
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Inclusion Criteria
2. The best corrected visual acuity (BCVA) is above 20/60;
3. Cataract opacity meets any of the following criterion based on lens opacity classification system (LOCS) III: nuclear color and nuclear opalescence is greater than or equal to grade 2 (NO2/NC2); cortical opacity is greater than or equal to grade 2 (C2); posterior subcapsular opacity is greater than or equal to grade 2 (P2);
4. Willing to know about cataract and cataract surgery;
5. Being able to afford cataract surgery;
6. Willing to participate in the study and provide the informed content.
Exclusion Criteria
2. Having hearing disorders;
3. Having mental disorders;
4. Having ocular disorders other than cataract;
5. Having surgery contraindication;
6. Unwilling to participate in this study.
50 Years
80 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Yingfeng Zheng
Clinical investigator
Principal Investigators
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Yingfeng Zheng, M.D. Ph.D.
Role: STUDY_DIRECTOR
Zhongshan Ophthalmic Center, Sun Yat-sen Univeristy
Locations
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Dashi Community Health Center
Guangzhou, , China
Donghuan Community Health Center
Guangzhou, , China
Huangcun Community Health Center
Guangzhou, , China
Huaying Community Health Center
Guangzhou, , China
Qiaonan Community Health Center
Guangzhou, , China
Shawan Community Health Center
Guangzhou, , China
Shibi Community Health Center
Guangzhou, , China
Shiqiao Community Health Center
Guangzhou, , China
Xiayuan Community Health Center
Guangzhou, , China
Yuancun Community Health Center
Guangzhou, , China
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Yurong Hu
Role: primary
Qiuling Xia
Role: primary
Shaochun Wang
Role: primary
Haifeng Wang
Role: primary
Weijian Chen
Role: primary
Yu Wong
Role: primary
Feiming Fan
Role: primary
Zhenhong Chen
Role: primary
Jiang Tan
Role: primary
Baoli Liu
Role: primary
Yizhi Liu
Role: primary
Other Identifiers
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2017KYPJ066
Identifier Type: -
Identifier Source: org_study_id