Guangdong Uptake of Surgery Trial

The Effect of Counseling in Cataract Screening: Guangdong Uptake of Surgery Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01123928

Acronym

GUSTO

Enrollment

434

Registered

2010-05-14

Start date

2010-07-31

Completion date

2011-06-30

Last updated

2012-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

cataract, counseling, surgical uptake, follow-up

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.

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.

Interventions

BEHAVIORALVideo 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
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.
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.
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.
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.

Countries

China

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.

Participants by arm

Arm	Count
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.	212
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.	222
Total	434

Baseline characteristics

Characteristic	Non-counseling	Counseling	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	203 Participants	183 Participants	386 Participants
Age, Categorical Between 18 and 65 years	19 Participants	29 Participants	48 Participants
Age Continuous	75.5 years STANDARD_DEVIATION 8	73.4 years STANDARD_DEVIATION 8.7	74.5 years STANDARD_DEVIATION 8.4
Region of Enrollment China	222 participants	212 participants	434 participants
Sex: Female, Male Female	121 Participants	128 Participants	249 Participants
Sex: Female, Male Male	101 Participants	84 Participants	185 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 212	0 / 222
serious Total, serious adverse events	0 / 212	0 / 222

Outcome results

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.

Time frame: within 6 months after screening examination

Population: All participants who completed the study were analyzed.

Arm	Measure	Value (NUMBER)
Counseling	Decision to Undergo Cataract Surgery (Surgery Acceptance)	31.1 percentage of participants
Non-counseling	Decision to Undergo Cataract Surgery (Surgery Acceptance)	34.2 percentage of 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.

Time frame: within 6 months after screening examination

Population: All participants who completed the study were analyzed.

Arm	Measure	Value (NUMBER)
Counseling	Attendance at Hospital for Pre-operative Examination	40.1 percentage of participants
Non-counseling	Attendance at Hospital for Pre-operative Examination	41.4 percentage of participants

Secondary