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

May 12, 2010
February 1, 2012
July 2010
June 2011   (final data collection date for primary outcome measure)
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.
Decision to undergo cataract surgery (surgery acceptance) [ Time Frame: within 30 days after pre-operative examination ] [ Designated as safety issue: No ]
As measured by patient's decision to undergo cataract surgery (positive) or refusal of surgery (negative).
Complete list of historical versions of study NCT01123928 on ClinicalTrials.gov Archive Site
  • 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.
  • attendance at hospital for pre-operative examination [ Time Frame: within 30 days after scheduled examination date ] [ Designated as safety issue: No ]
  • attendance at follow-up examinations [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
  • predictors of surgery acceptance [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
    predictors assessed by Barriers Questionnaire
  • predictors of pre-operative examination attendance [ Time Frame: within 30 days after scheduled examination date ] [ Designated as safety issue: No ]
    predictors assessed by Barriers Questionnaire
  • predictors of follow-up attendance [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
    predictors assessed by Barriers Questionnaire
  • patient satisfaction with surgery [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
    As measured by a short questionnaire.
Not Provided
Not Provided
 
Guangdong Uptake of Surgery Trial
The Effect of Counseling in Cataract Screening: Guangdong Uptake of Surgery Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Cataract
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.
  • 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.
    Intervention: Behavioral: Video and counseling for cataract patients
  • No Intervention: Non-counseling

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
434
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01123928
ZOC-123
No
Congdon Nathan, Sun Yat-sen University
Sun Yat-sen University
  • Swarthmore College
  • Helen Keller International
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
Sun Yat-sen University
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP