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| Name | Class |
|---|---|
| Swarthmore College | OTHER |
| Helen Keller International | OTHER |
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The purpose of this study is:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Counseling | Experimental | 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 | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video and counseling for cataract patients | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Decision to Undergo Cataract Surgery (Surgery Acceptance) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Attendance at Hospital for Pre-operative 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center | Guangzhou | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17515966 | Background | Tan L. Increasing the volume of cataract surgery: an experience in rural China. Community Eye Health. 2006 Dec;19(60):61-3. No abstract available. | |
| 1904845 | Background | 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. doi: 10.1007/BF00153924. |
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Subjects were recruited from 32 outreach screening sessions in various villages and townships of Guangdong province from June 2010 to November 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Non-counseling |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Decision to Undergo Cataract Surgery (Surgery Acceptance) | Measured as a percentage of subjects who decide to undergo cataract surgery within 6 months after screening (positive) out of total subjects. | All participants who completed the study were analyzed. | Posted | Number | percentage of participants | within 6 months after screening examination |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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One of the six participating hospitals did not adhere to protocol, and thus total number of subjects analyzed was smaller than originally anticipated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nathan Congdon | Zhongshan Ophthalmic Center | 13925056342 | ncongdon1@gmail.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014743 | Videotape Recording |
| D003376 | Counseling |
| ID | Term |
|---|---|
| D013637 | Tape Recording |
| D001296 | Audiovisual Aids |
| D018961 | Educational Technology |
| D013672 | Technology |
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|
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 | 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 | 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" | 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 | Measured as a percentage of subjects who agree with the statement in a questionnaire. | Assessed during day of screening examination |
| 22789919 | Derived | Liu T, Congdon N, Yan X, Jin L, Wu Y, Friedman D, He M. A randomized, controlled trial of an intervention promoting cataract surgery acceptance in rural China: the Guangzhou Uptake of Surgery Trial (GUSTO). Invest Ophthalmol Vis Sci. 2012 Aug 13;53(9):5271-8. doi: 10.1167/iovs.12-9798. |
| 22661464 | Derived | Barry MP, Dagnelie G; Argus II Study Group. Use of the Argus II retinal prosthesis to improve visual guidance of fine hand movements. Invest Ophthalmol Vis Sci. 2012 Aug 1;53(9):5095-101. doi: 10.1167/iovs.12-9536. |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Attendance at Hospital for Pre-operative Examination | Measured as a percentage of people who presented to the hospital within 6 months after screening (positive) out of total subjects. | All participants who completed the study were analyzed. | Posted | Number | percentage of participants | within 6 months after screening examination |
|
|
|
| Secondary | Knowledge That Cataract Can be Treated | Measured as a percentage of subjects who correctly answer the question in a questionnaire. | Analysis was conducted for all participants who responded to this question in the survey. | Posted | Number | percentage of respondents | Assessed during day of screening examination |
|
|
|
| Secondary | Belief That Surgery Will be Painful | Measured as a percentage of subjects who agree with the statement in a questionnaire. | Analysis was conducted for all participants who responded to this question in the survey. | Posted | Number | percentage of respondents | Assessed during day of screening examination |
|
|
|
| Secondary | Belief That Vision Will Improve "a Lot" Following Surgery | Measured as a percentage of subjects who agree with the statement in a questionnaire. | Analysis was conducted for all participants who responded to this question in the survey. | Posted | Number | percentage of respondents | Assessed during day of screening examination |
|
|
|
| Secondary | Belief That Surgeons at the Hospital Are "Highly Skilled" | Measured as a percentage of subjects who agree with the statement in a questionnaire. | Analysis was conducted for all participants who responded to this question in the survey. | Posted | Number | percentage of respondents | Assessed during day of screening examination |
|
|
|
| Secondary | Belief That Doctors and Nurses at the Hospital Have "Very Good" Attitudes | Measured as a percentage of subjects who agree with the statement in a questionnaire. | Analysis was conducted for all participants who responded to this question in the survey. | Posted | Number | percentage of respondents | Assessed during day of screening examination |
|
|
|
| 0 |
| 212 |
| 0 |
| 212 |
| EG001 | 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. | 0 | 222 | 0 | 222 |
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| D013676 |
| Technology, Industry, and Agriculture |
| D013690 | Television |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |