Impact of a Printed Decision Aid on Cataract Surgery Choice
1 other identifier
interventional
696
1 country
11
Brief Summary
The purpose of the study is to explore whether a decision aid booklet is more effective than the usual booklet for patients to make an informed choice on cataract surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2018
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2018
CompletedFirst Posted
Study publicly available on registry
May 15, 2018
CompletedStudy Start
First participant enrolled
May 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2019
CompletedDecember 26, 2018
December 1, 2018
6 months
April 12, 2018
December 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Informed choice about cataract surgery
Informed choice is measured as the proportion of participants who make an informed choice about whether to receive cataract surgery as soon as possible or not. For the individual, making an informed choice is defined as (i) having adequate knowledge and (ii) expressing intentions that are consistent with （iii）one's attitudes. Knowledge will be measured by assessing participants' understanding of the numerical and conceptual information in the booklets, using items modified from previous screening decision aid trials (Hersch 2015). Attitudes towards cataract surgery will be assessed using a theory-based generic screening attitudes scale (Dormandy 2006). A single item will measure intentions about having cataract surgery as soon as possible (or not), using a set of 5 response options (Gwyn 2003; Watson 2006).
2 weeks
Secondary Outcomes (10)
Perceived importance of cataract surgery benefit/harms
2 weeks
Perceived personal chances of surgical benefit/harms
2 weeks
Decisional conflict
2 weeks
Decisional confidence
2 weeks
Time perspective
2 weeks
- +5 more secondary outcomes
Study Arms (2)
A decision aid booklet
EXPERIMENTALA decision aid booklet about cataract surgery choice
An usual booklet
ACTIVE COMPARATORAn usual booklet about cataract and cataract surgery
Interventions
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.
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
You may qualify if:
- Definite diagnosis of age-related cataract;
- The best corrected visual acuity (BCVA) is above 20/60;
- 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);
- Willing to know about cataract and cataract surgery;
- Being able to afford cataract surgery;
- Willing to participate in the study and provide the informed content.
You may not qualify if:
- Having received cataract surgery;
- Having hearing disorders;
- Having mental disorders;
- Having ocular disorders other than cataract;
- Having surgery contraindication;
- Unwilling to participate in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yingfeng Zheng, M.D. Ph.D.
Zhongshan Ophthalmic Center, Sun Yat-sen Univeristy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical investigator
Study Record Dates
First Submitted
April 12, 2018
First Posted
May 15, 2018
Study Start
May 16, 2018
Primary Completion
October 30, 2018
Study Completion
October 30, 2019
Last Updated
December 26, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share