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Guangdong Uptake of Surgery Trial (GUSTO)

This study has been completed.
Sponsor:
Collaborators:
Swarthmore College
Helen Keller International
Information provided by (Responsible Party):
Congdon Nathan, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01123928
First received: May 12, 2010
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

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.

Condition Intervention
Cataract
Behavioral: Video and counseling for cataract patients

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effect of Counseling in Cataract Screening: Guangdong Uptake of Surgery Trial

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Decision to Undergo Cataract Surgery (Surgery Acceptance) [ Time Frame: within 6 months after screening examination ] [ Designated as safety issue: No ]
    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 [ Time Frame: within 6 months after screening examination ] [ Designated as safety issue: No ]
    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 [ Time Frame: Assessed during day of screening examination ] [ Designated as safety issue: No ]
    Measured as a percentage of subjects who correctly answer the question in a questionnaire.

  • Belief That Surgery Will be Painful [ Time Frame: Assessed during day of screening examination ] [ Designated as safety issue: No ]
    Measured as a percentage of subjects who agree with the statement in a questionnaire.

  • Belief That Vision Will Improve "a Lot" Following Surgery [ Time Frame: Assessed during day of screening examination ] [ Designated as safety issue: No ]
    Measured as a percentage of subjects who agree with the statement in a questionnaire.

  • Belief That Surgeons at the Hospital Are "Highly Skilled" [ Time Frame: Assessed during day of screening examination ] [ Designated as safety issue: No ]
    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 [ Time Frame: Assessed during day of screening examination ] [ Designated as safety issue: No ]
    Measured as a percentage of subjects who agree with the statement in a questionnaire.


Enrollment: 434
Study Start Date: July 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Counseling
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
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.
No Intervention: Non-counseling

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01123928

Locations
China, Guangdong
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, China
Sponsors and Collaborators
Sun Yat-sen University
Swarthmore College
Helen Keller International
Investigators
Principal Investigator: Nathan Congdon, MD, MPH Zhongshan Ophthalmic Center
Principal Investigator: Mingguang He, PHD, MPH Zhongshan Ophthalmic Center
Principal Investigator: David Friedman, MD, MPH Johns Hopkins University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Congdon Nathan, Dr. Nathan Congdon, MD, MPH, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01123928     History of Changes
Other Study ID Numbers: ZOC-123
Study First Received: May 12, 2010
Results First Received: December 28, 2011
Last Updated: February 1, 2012
Health Authority: United States: Institutional Review Board
China: Ethics Committee

Keywords provided by Sun Yat-sen University:
cataract
counseling
surgical uptake
follow-up

Additional relevant MeSH terms:
Cataract
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on November 24, 2014