Guangdong Uptake of Surgery Trial

Cataract Clinical Trial

— GUSTO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01123928
• Other study ID #: ZOC-123
• Status: Completed
• Phase: N/A
• First received: May 12, 2010
• Last updated: February 1, 2012
• Start date: July 2010
• Est. completion date: June 2011

Study information

• Verified date: February 2012
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardChina: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is:

1. 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;

2. To assess short-term impact of the educational intervention on knowledge about cataract and attitudes toward locally-available surgical services.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 434
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cataract

Intervention

Behavioral:
• Video and counseling for cataract patients
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.

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Sun Yat-sen University	Helen Keller International, Swarthmore College

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

Tan L. Increasing the volume of cataract surgery: an experience in rural China. Community Eye Health. 2006 Dec;19(60):61-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No