Guangdong Uptake of Surgery Trial

NCT01123928 | Completed Results

• 1 other identifier: ZOC-123
• Study Type: interventional
• Target: 434
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is:

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

Conditions

Cataract

Keywords

cataract; counseling; surgical uptake; follow-up

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Attendance at Hospital for Pre-operative Examination

  within 6 months after screening examination

• Knowledge That Cataract Can be Treated

  Assessed during day of screening examination

• Belief That Surgery Will be Painful

  Assessed during day of screening examination

• Belief That Vision Will Improve "a Lot" Following Surgery

  Assessed during day of screening examination

• Belief That Surgeons at the Hospital Are "Highly Skilled"

  Assessed during day of screening examination

Study Arms (2)

Counseling

EXPERIMENTAL

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

Non-counseling

NO INTERVENTION

Interventions

Video and counseling for cataract patients BEHAVIORAL

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.

Counseling

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• traumatic cataract
• inability to give informed consent due to dementia or other reasons.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Swarthmore College: collaborator
• Helen Keller International: collaborator

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

Location

Related Publications (4)

• 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.

  PMID: 17515966 BACKGROUND

• 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.

  PMID: 1904845 BACKGROUND

• 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.

  PMID: 22789919 DERIVED

• 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.

  PMID: 22661464 DERIVED

MeSH Terms

Conditions

Cataract

Interventions

Videotape Recording; Counseling

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

One of the six participating hospitals did not adhere to protocol, and thus total number of subjects analyzed was smaller than originally anticipated.

Results Point of Contact

• Title: Dr. Nathan Congdon
• Organization: Zhongshan Ophthalmic Center

ncongdon1@gmail.com

13925056342

Study Officials

• Nathan Congdon, MD, MPH

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Mingguang He, PHD, MPH

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• David Friedman, MD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Nathan Congdon, MD, MPH

Study Record Dates

• First Submitted: May 12, 2010
• First Posted: May 14, 2010
• Study Start: July 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: February 3, 2012
• Results First Posted: February 2, 2012

Record last verified: 2012-02

Locations

CN (1)