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| Name | Class |
|---|---|
| Wenzhou Medical University | OTHER |
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Overall Objective: This study will assess whether an educational video is effective in increasing patient satisfaction with glaucoma surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Education group | Experimental | Subjects will be asked to watch a 5-10 min education film two times (pre-op one day and post-op one day). |
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| Control group | No Intervention | Standard patient procedure that includes a pre-operative discussion with an ophthalmologist about glaucoma surgery, during which the surgeon gains the patient's informed consent. Subjects will not be asked to watch education film.. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Video | Other | The film follows the journey of an elderly patient scheduled to undergo glaucoma surgery, beginning with a face-to-face Q&A health session with an eye doctor. After surgery, the patient talks about his post-operative eyesight and discusses the benefits of early diagnosis and glaucoma surgery for treatment with his community. |
| Measure | Description | Time Frame |
|---|---|---|
| The mean satisfaction outcome over two follow-up visits | The primary outcome is the mean satisfaction score calculated by adding up the satisfaction scores at two follow-up visits: 1 day and 1 week after surgery and dividing the total by the number of scores. The satisfaction score will be 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) | 1 day, 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of willingness to recommend surgery to a friend or relative with glaucoma | The measurement method: questionnaire | 1 day, 1 week |
| Personality in both groups using Eysenck Personality Questionnaire-Revised Short Scale for Chinese (EPQ-RSC) access glaucoma patients personality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathan Congdon, MD,MPH | The Key Laboratory,Zhongshan Ophthalmic Center,Sun Yat-sen University | Principal Investigator |
| Yuanbo Liang, MD, PhD | The Eye Hospital, Wenzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Eye Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 18, 2019 | May 20, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D001519 | Behavior |
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The measurement method: questionnaire. The questionnaire provides subscores for 5 categories (Short, Extraversion, Neuroticism, Psychoticism, Lie score), with a higher corresponding to a higher characterization of that particular trait. |
| Baseline (before surgery) |
| Knowledge scores about glaucoma | The measurement method: questionnaire. Mean knowledge scores is calculated by adding up the scores at two follow-up visits: 1 day and 1 week after surgery and dividing the total by the number of scores. Knowledge scores will be assessed as a cumulative score, and will be compared with the baseline pre-operative score. | Baseline (before surgery); 1 day and 1 week after surgery |
| Intraocular pressure in both groups | Unit of Intraocular pressure is mmHg. | Baseline (before surgery); 1 day and 1 week after surgery |
| 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) | Baseline (before surgery); 1 day and 1 week after surgery |