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Satisfaction After Glaucoma Surgery in Rural China

Primary Purpose

Glaucoma

Status
Withdrawn
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Multifaceted education
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Glaucoma focused on measuring glaucoma surgery, educational intervention, satisfaction, rural

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age≥18 years, glaucoma patients who do the peripheral iridectomy or trabeculotomy

Exclusion Criteria:

  • patients who had been the trabeculotomy, vision≤0.05, severe psychotic disorders and dysgnosia

Sites / Locations

  • Blindness Preventment and Treatment Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Multifaceted education group

control group

Arm Description

Subjects will be asked to watch a 5-10 min education film and participate in a 10-15 min counseling session with a trained doctor/nurse before glaucoma surgery,and at 1 week and 2 week after surgery.

Subjects will not be asked to watch education film and not participate in counseling session before and after surgery.

Outcomes

Primary Outcome Measures

The mean satisfaction score over three follow-up visits
The primary outcome is the mean satisfaction score calculated by adding up the satisfaction scores at three follow-up visits: 1 week, 2 week and 4 week after surgery and dividing the total by the number of scores. The satisfaction score was assessed as a cumulative score. Composite outcome, in which multiple end points are combined, are frequently used as primary outcome measures in randomized trials and are often associated with increased statistical efficiency, although such measure may prove challenging for the interpretation of results. (Freemantle N, Calvert M, Wood J, Eastaugh J, Griffin C. Composite outcomes in randomized trials: greater precision but with greater uncertainty? JAMA. 2003; 289: 2554-2559)

Secondary Outcome Measures

The rate of willingness to recommend surgery to a friend or relative with glaucoma
The measurement method:questionnaire
Personality in both groups using Eysenck Personality Questionnaire-Revised Short Scale for Chinese (EPQ-RSC) access glaucoma patients personality
Knowledge scores about glaucoma
Intraocular pressure in both groups
Unit of Intraocular pressure is mmHg.
visual acuity in both groups
Visual acuity testing use Snellen-based letter charts,such as a Snellen score of 6/12 (20/40), indicating an observer can resolve details as small 2 minutes of visual angle, corresponds to a LogMAR of 0.3 (since the base-10 logarithm of 2 is 0.3)

Full Information

First Posted
October 9, 2015
Last Updated
September 21, 2021
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02629237
Brief Title
Satisfaction After Glaucoma Surgery in Rural China
Official Title
Impact of Multifaceted Education on Satisfaction After Glaucoma Surgery in Rural China
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
study sites were reconsidered.
Study Start Date
March 2022 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Investigate degree of postoperative satisfaction in county level hospital glaucoma patients. Investigate the effect of educational intervention affect the degree of satisfaction in glaucoma patients. Investigate the effect factors of postoperative satisfaction.
Detailed Description
Glaucoma is the leading cause of irreversible blindness in China, as elsewhere in the world. In Chinese rural settings, where topical glaucoma medication is unlikely to be a practical and sustainable option, surgery is the primary treatment modality for glaucoma. However, it is known that vision is quite likely to decline in the short to medium term after glaucoma surgery, and there are concerns that dis-satisfaction resulting from such vision changes might lead to negative social marketing, affecting uptake not only of glaucoma surgical care but other eye operations (principally cataract) as well. We propose to test the impact on post-operative satisfaction of a multi-media educational intervention designed to give patients a realistic expectation of their post operative course: glaucoma surgery is being performed NOT to improve vision, but do protect it from future harm, and vision may in fact decline for several weeks post operatively. A randomized controlled design will be used, and subjects undergoing glaucoma surgery will be enrolled at 4 rural county hospitals in rural Guangdong province, and randomized to receive the intervention or usual care. The principal outcome will be subjective satisfaction on a previously-tested questionnaire instrument, administered pre-operatively and post-operatively on two occasions in the first month following surgery. Patients not returning post-operatively to the surgical facility will be contacted by telephone for administration of the questionnaire. Other facility- and patient-related clinical and personal factors expected to influence satisfaction will also be recorded, and adjusted for in all analyses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
glaucoma surgery, educational intervention, satisfaction, rural

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multifaceted education group
Arm Type
Experimental
Arm Description
Subjects will be asked to watch a 5-10 min education film and participate in a 10-15 min counseling session with a trained doctor/nurse before glaucoma surgery,and at 1 week and 2 week after surgery.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Subjects will not be asked to watch education film and not participate in counseling session before and after surgery.
Intervention Type
Other
Intervention Name(s)
Multifaceted education
Intervention Description
Subjects will be asked to watch a 5-10 min education film and participate in a 10-15 min counseling session with a trained doctor/nurse before glaucoma surgery,and at 1 week and 2 week after surgery.
Primary Outcome Measure Information:
Title
The mean satisfaction score over three follow-up visits
Description
The primary outcome is the mean satisfaction score calculated by adding up the satisfaction scores at three follow-up visits: 1 week, 2 week and 4 week after surgery and dividing the total by the number of scores. The satisfaction score was assessed as a cumulative score. Composite outcome, in which multiple end points are combined, are frequently used as primary outcome measures in randomized trials and are often associated with increased statistical efficiency, although such measure may prove challenging for the interpretation of results. (Freemantle N, Calvert M, Wood J, Eastaugh J, Griffin C. Composite outcomes in randomized trials: greater precision but with greater uncertainty? JAMA. 2003; 289: 2554-2559)
Time Frame
1 week, 2 week and 4 week after surgery.
Secondary Outcome Measure Information:
Title
The rate of willingness to recommend surgery to a friend or relative with glaucoma
Description
The measurement method:questionnaire
Time Frame
1 week, 2 week and 4 week after surgery.
Title
Personality in both groups using Eysenck Personality Questionnaire-Revised Short Scale for Chinese (EPQ-RSC) access glaucoma patients personality
Time Frame
before surgery
Title
Knowledge scores about glaucoma
Time Frame
before surgery and 1 week, 2 week and 4 week after surgery
Title
Intraocular pressure in both groups
Description
Unit of Intraocular pressure is mmHg.
Time Frame
before surgery and 1 week, 2 week and 4 week after surgery
Title
visual acuity in both groups
Description
Visual acuity testing use Snellen-based letter charts,such as a Snellen score of 6/12 (20/40), indicating an observer can resolve details as small 2 minutes of visual angle, corresponds to a LogMAR of 0.3 (since the base-10 logarithm of 2 is 0.3)
Time Frame
before surgery and 1 week, 2 week and 4 week after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age≥18 years, glaucoma patients who do the peripheral iridectomy or trabeculotomy Exclusion Criteria: patients who had been the trabeculotomy, vision≤0.05, severe psychotic disorders and dysgnosia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan Congdon, MD,MPH
Organizational Affiliation
The Key Laboratory,Zhongshan Ophthalmic Center,Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Blindness Preventment and Treatment Department
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

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Satisfaction After Glaucoma Surgery in Rural China

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