Guangdong Uptake of Surgery Trial (GUSTO)
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Video and counseling for cataract patients
Sponsored by
About this trial
This is an interventional prevention trial for Cataract focused on measuring cataract, counseling, surgical uptake, follow-up
Eligibility Criteria
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.
Sites / Locations
- Zhongshan Ophthalmic Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Counseling
Non-counseling
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Knowledge That Cataract Can be Treated
Measured as a percentage of subjects who correctly answer the question in a questionnaire.
Belief That Surgery Will be Painful
Measured as a percentage of subjects who agree with the statement in a questionnaire.
Belief That Vision Will Improve "a Lot" Following Surgery
Measured as a percentage of subjects who agree with the statement in a questionnaire.
Belief That Surgeons at the Hospital Are "Highly Skilled"
Measured as a percentage of subjects who agree with the statement in a questionnaire.
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.
Full Information
NCT ID
NCT01123928
First Posted
May 12, 2010
Last Updated
February 1, 2012
Sponsor
Sun Yat-sen University
Collaborators
Swarthmore College, Helen Keller International
1. Study Identification
Unique Protocol Identification Number
NCT01123928
Brief Title
Guangdong Uptake of Surgery Trial
Acronym
GUSTO
Official Title
The Effect of Counseling in Cataract Screening: Guangdong Uptake of Surgery Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Swarthmore College, Helen Keller International
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
cataract, counseling, surgical uptake, follow-up
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
434 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-counseling
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Video and counseling for cataract patients
Intervention Description
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.
Primary Outcome Measure Information:
Title
Decision to Undergo Cataract Surgery (Surgery Acceptance)
Description
Measured as a percentage of subjects who decide to undergo cataract surgery within 6 months after screening (positive) out of total subjects.
Time Frame
within 6 months after screening examination
Secondary Outcome Measure Information:
Title
Attendance at Hospital for Pre-operative Examination
Description
Measured as a percentage of people who presented to the hospital within 6 months after screening (positive) out of total subjects.
Time Frame
within 6 months after screening examination
Title
Knowledge That Cataract Can be Treated
Description
Measured as a percentage of subjects who correctly answer the question in a questionnaire.
Time Frame
Assessed during day of screening examination
Title
Belief That Surgery Will be Painful
Description
Measured as a percentage of subjects who agree with the statement in a questionnaire.
Time Frame
Assessed during day of screening examination
Title
Belief That Vision Will Improve "a Lot" Following Surgery
Description
Measured as a percentage of subjects who agree with the statement in a questionnaire.
Time Frame
Assessed during day of screening examination
Title
Belief That Surgeons at the Hospital Are "Highly Skilled"
Description
Measured as a percentage of subjects who agree with the statement in a questionnaire.
Time Frame
Assessed during day of screening examination
Title
Belief That Doctors and Nurses at the Hospital Have "Very Good" Attitudes
Description
Measured as a percentage of subjects who agree with the statement in a questionnaire.
Time Frame
Assessed during day of screening examination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Congdon, MD, MPH
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mingguang He, PHD, MPH
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Friedman, MD, MPH
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center
City
Guangzhou
State/Province
Guangdong
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
17515966
Citation
Tan L. Increasing the volume of cataract surgery: an experience in rural China. Community Eye Health. 2006 Dec;19(60):61-3. No abstract available.
Results Reference
background
PubMed Identifier
1904845
Citation
Ellwein LB, Lepkowski JM, Thulasiraj RD, Brilliant GE. The cost effectiveness of strategies to reduce barriers to cataract surgery. The Operations Research Group. Int Ophthalmol. 1991 May;15(3):175-83. doi: 10.1007/BF00153924.
Results Reference
background
PubMed Identifier
22789919
Citation
Liu T, Congdon N, Yan X, Jin L, Wu Y, Friedman D, He M. A randomized, controlled trial of an intervention promoting cataract surgery acceptance in rural China: the Guangzhou Uptake of Surgery Trial (GUSTO). Invest Ophthalmol Vis Sci. 2012 Aug 13;53(9):5271-8. doi: 10.1167/iovs.12-9798.
Results Reference
derived
PubMed Identifier
22661464
Citation
Barry MP, Dagnelie G; Argus II Study Group. Use of the Argus II retinal prosthesis to improve visual guidance of fine hand movements. Invest Ophthalmol Vis Sci. 2012 Aug 1;53(9):5095-101. doi: 10.1167/iovs.12-9536.
Results Reference
derived
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Guangdong Uptake of Surgery Trial
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