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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
Results First Received: December 28, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Cataract
Intervention: Behavioral: Video and counseling for cataract patients

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from 32 outreach screening sessions in various villages and townships of Guangdong province from June 2010 to November 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
(none)

Reporting Groups
  Description
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.
Non-counseling Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.

Participant Flow:   Overall Study
    Counseling     Non-counseling  
STARTED     212     222  
COMPLETED     212     222  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Non-counseling Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
Total Total of all reporting groups

Baseline Measures
    Counseling     Non-counseling     Total  
Number of Participants  
[units: participants]
  212     222     434  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     29     19     48  
>=65 years     183     203     386  
Age  
[units: years]
Mean ± Standard Deviation
  73.4  ± 8.7     75.5  ± 8.0     74.5  ± 8.4  
Gender  
[units: participants]
     
Female     128     121     249  
Male     84     101     185  
Region of Enrollment  
[units: participants]
     
China     212     222     434  



  Outcome Measures
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1.  Primary:   Decision to Undergo Cataract Surgery (Surgery Acceptance)   [ Time Frame: within 6 months after screening examination ]

2.  Secondary:   Attendance at Hospital for Pre-operative Examination   [ Time Frame: within 6 months after screening examination ]

3.  Secondary:   Knowledge That Cataract Can be Treated   [ Time Frame: Assessed during day of screening examination ]

4.  Secondary:   Belief That Surgery Will be Painful   [ Time Frame: Assessed during day of screening examination ]

5.  Secondary:   Belief That Vision Will Improve "a Lot" Following Surgery   [ Time Frame: Assessed during day of screening examination ]

6.  Secondary:   Belief That Surgeons at the Hospital Are "Highly Skilled"   [ Time Frame: Assessed during day of screening examination ]

7.  Secondary:   Belief That Doctors and Nurses at the Hospital Have "Very Good" Attitudes   [ Time Frame: Assessed during day of screening examination ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
One of the six participating hospitals did not adhere to protocol, and thus total number of subjects analyzed was smaller than originally anticipated.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Nathan Congdon
Organization: Zhongshan Ophthalmic Center
phone: 13925056342
e-mail: ncongdon1@gmail.com


Publications:
Publications automatically indexed to this study:

Responsible Party: Congdon Nathan, 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