GUSTO: Guangdong Uptake of Surgery Trial

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01123928
• Collaborator: Swarthmore College (Other), Helen Keller International (Other)
• Enrollment: 434
• Location: 1
• Arms: 2
• Duration (Months): 11
• Patients Per Site Per Month: 39.4

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Cataract	Behavioral: Video and counseling for cataract patients	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 434 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: The Effect of Counseling in Cataract Screening: Guangdong Uptake of Surgery Trial
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Decision to Undergo Cataract Surgery (Surgery Acceptance) [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.

Secondary Outcome Measures

1. Attendance at Hospital for Pre-operative Examination [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.

2. Knowledge That Cataract Can be Treated [Assessed during day of screening examination]

   Measured as a percentage of subjects who correctly answer the question in a questionnaire.

3. Belief That Surgery Will be Painful [Assessed during day of screening examination]

   Measured as a percentage of subjects who agree with the statement in a questionnaire.

4. Belief That Vision Will Improve "a Lot" Following Surgery [Assessed during day of screening examination]

   Measured as a percentage of subjects who agree with the statement in a questionnaire.

5. Belief That Surgeons at the Hospital Are "Highly Skilled" [Assessed during day of screening examination]

   Measured as a percentage of subjects who agree with the statement in a questionnaire.

6. Belief That Doctors and Nurses at the Hospital Have "Very Good" Attitudes [Assessed during day of screening examination]

   Measured as a percentage of subjects who agree with the statement in a questionnaire.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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, 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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• Tan L. Increasing the volume of cataract surgery: an experience in rural China. Community Eye Health. 2006 Dec;19(60):61-3.

• Responsible Party: Congdon Nathan, Dr. Nathan Congdon, MD, MPH, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT01123928
• Other Study ID Numbers: ZOC-123
• First Posted: May 14, 2010
• Last Update Posted: Feb 3, 2012
• Last Verified: Feb 1, 2012

• Keywords provided by Congdon Nathan, Dr. Nathan Congdon, MD, MPH, Sun Yat-sen University: cataract; counseling; surgical uptake; follow-up
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 32 outreach screening sessions in various villages and townships of Guangdong province from June 2010 to November 2010.

Arm/Group Title	Counseling	Non-counseling
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	212	222
COMPLETED	212	222
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Counseling	Non-counseling	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	212	222	434
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	29 13.7%	19 8.6%	48 11.1%
>=65 years	183 86.3%	203 91.4%	386 88.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	73.4 (8.7)	75.5 (8.0)	74.5 (8.4)
Sex: Female, Male (Count of Participants)
Female	128 60.4%	121 54.5%	249 57.4%
Male	84 39.6%	101 45.5%	185 42.6%
Region of Enrollment (participants) [Number]
China	212 100%	222 100%	434 100%

Outcome Measures

1. Primary Outcome

Title	Decision to Undergo Cataract Surgery (Surgery Acceptance)
Description	Measured as a percentage of subjects who decide to undergo cataract surgery within 6 months after screening (positive) out of total subjects.
Time Frame	within 6 months after screening examination

Outcome Measure Data

Analysis Population Description

All participants who completed the study were analyzed.

Arm/Group Title	Counseling	Non-counseling
Arm/Group Description	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.	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.
Measure Participants	212	222
Number [percentage of participants]	31.1 14.7%	34.2 15.4%

2. Secondary Outcome

Title	Attendance at Hospital for Pre-operative Examination
Description	Measured as a percentage of people who presented to the hospital within 6 months after screening (positive) out of total subjects.
Time Frame	within 6 months after screening examination

Outcome Measure Data

Analysis Population Description

All participants who completed the study were analyzed.

Arm/Group Title	Counseling	Non-counseling
Arm/Group Description	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.	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.
Measure Participants	212	222
Number [percentage of participants]	40.1 18.9%	41.4 18.6%

3. Secondary Outcome

Title	Knowledge That Cataract Can be Treated
Description	Measured as a percentage of subjects who correctly answer the question in a questionnaire.
Time Frame	Assessed during day of screening examination

Outcome Measure Data

Analysis Population Description

Analysis was conducted for all participants who responded to this question in the survey.

Arm/Group Title	Counseling	Non-counseling
Arm/Group Description	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.	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.
Measure Participants	212	222
Number [percentage of respondents]	87.7	79.7

4. Secondary Outcome

Title	Belief That Surgery Will be Painful
Description	Measured as a percentage of subjects who agree with the statement in a questionnaire.
Time Frame	Assessed during day of screening examination

Outcome Measure Data

Analysis Population Description

Analysis was conducted for all participants who responded to this question in the survey.

Arm/Group Title	Counseling	Non-counseling
Arm/Group Description	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.	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.
Measure Participants	212	222
Number [percentage of respondents]	48.1	57.7

5. Secondary Outcome

Title	Belief That Vision Will Improve "a Lot" Following Surgery
Description	Measured as a percentage of subjects who agree with the statement in a questionnaire.
Time Frame	Assessed during day of screening examination

Outcome Measure Data

Analysis Population Description

Analysis was conducted for all participants who responded to this question in the survey.

Arm/Group Title	Counseling	Non-counseling
Arm/Group Description	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.	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.
Measure Participants	212	222
Number [percentage of respondents]	62.0	54.0

6. Secondary Outcome

Title	Belief That Surgeons at the Hospital Are "Highly Skilled"
Description	Measured as a percentage of subjects who agree with the statement in a questionnaire.
Time Frame	Assessed during day of screening examination

Outcome Measure Data

Analysis Population Description

Analysis was conducted for all participants who responded to this question in the survey.

Arm/Group Title	Counseling	Non-counseling
Arm/Group Description	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.	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.
Measure Participants	212	222
Number [percentage of respondents]	74.1	79.4

7. Secondary Outcome

Title	Belief That Doctors and Nurses at the Hospital Have "Very Good" Attitudes
Description	Measured as a percentage of subjects who agree with the statement in a questionnaire.
Time Frame	Assessed during day of screening examination

Outcome Measure Data

Analysis Population Description

Analysis was conducted for all participants who responded to this question in the survey.

Arm/Group Title	Counseling	Non-counseling
Arm/Group Description	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.	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.
Measure Participants	212	222
Number [percentage of respondents]	81.9	82.9

Adverse Events

Arm/Group Title	Counseling		Non-counseling
Arm/Group Description	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.		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.
All Cause Mortality
	Counseling		Non-counseling
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Counseling		Non-counseling
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/212 (0%)		0/222 (0%)
Other (Not Including Serious) Adverse Events
	Counseling		Non-counseling
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/212 (0%)		0/222 (0%)

Limitations/Caveats

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

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.