Guangdong Uptake of Surgery Trial (GUSTO)

February 1, 2012 updated by: Congdon Nathan, Sun Yat-sen University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
434

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Zhongshan Ophthalmic Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Decision to Undergo Cataract Surgery (Surgery Acceptance)
Time Frame: within 6 months after screening examination
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Attendance at Hospital for Pre-operative Examination
Time Frame: within 6 months after screening 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
Knowledge That Cataract Can be Treated
Time Frame: Assessed during day of screening examination
Measured as a percentage of subjects who correctly answer the question in a questionnaire.
Assessed during day of screening examination
Belief That Surgery Will be Painful
Time Frame: Assessed during day of screening examination
Measured as a percentage of subjects who agree with the statement in a questionnaire.
Assessed during day of screening examination
Belief That Vision Will Improve "a Lot" Following Surgery
Time Frame: Assessed during day of screening examination
Measured as a percentage of subjects who agree with the statement in a questionnaire.
Assessed during day of screening examination
Belief That Surgeons at the Hospital Are "Highly Skilled"
Time Frame: Assessed during day of screening examination
Measured as a percentage of subjects who agree with the statement in a questionnaire.
Assessed during day of screening examination
Belief That Doctors and Nurses at the Hospital Have "Very Good" Attitudes
Time Frame: Assessed during day of screening examination
Measured as a percentage of subjects who agree with the statement in a questionnaire.
Assessed during day of screening examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Helen Keller International
Swarthmore College

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZOC-123

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