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Impact of an Educational Video on Satisfaction After Glaucoma Surgery

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ClinicalTrials.gov Identifier: NCT03958929
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Collaborator:
Wenzhou Medical University
Information provided by (Responsible Party):
Congdon Nathan, Sun Yat-sen University

Brief Summary:

Overall Objective: This study will assess whether an educational video is effective in increasing patient satisfaction with glaucoma surgery.

  1. Investigate the impact of educational interventions on glaucoma patients' surgical satisfaction.
  2. Investigate the post-operative satisfaction of rural glaucoma patients in county hospitals
  3. Investigate the difference in postoperative satisfaction between urban and rural glaucoma patients in urban hospitals
  4. Investigate other factors that influence postoperative glaucoma satisfaction.

Condition or disease Intervention/treatment Phase
Glaucoma Other: Educational Video Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Randomized Controlled Trial on the Impact of an Educational Video on Satisfaction After Glaucoma Surgery in Urban and Rural China
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: Education group
Subjects will be asked to watch a 5-10 min education film two times (pre-op one day and post-op one day).
Other: Educational Video
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.

No Intervention: Control group
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..



Primary Outcome Measures :
  1. The mean satisfaction outcome over two follow-up visits [ Time Frame: 1 day, 1 week ]

    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)



Secondary Outcome Measures :
  1. The rate of willingness to recommend surgery to a friend or relative with glaucoma [ Time Frame: 1 day, 1 week ]
    The measurement method: questionnaire

  2. Personality in both groups using Eysenck Personality Questionnaire-Revised Short Scale for Chinese (EPQ-RSC) access glaucoma patients personality [ Time Frame: Baseline (before surgery) ]
    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.

  3. Knowledge scores about glaucoma [ Time Frame: Baseline (before surgery); 1 day and 1 week after surgery ]

    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.


  4. Intraocular pressure in both groups [ Time Frame: Baseline (before surgery); 1 day and 1 week after surgery ]
    Unit of Intraocular pressure is mmHg.

  5. visual acuity in both groups [ Time Frame: Baseline (before surgery); 1 day and 1 week after surgery ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958929


Contacts
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Contact: Nathan Congdon, MD,MPH +8602087682342 ncongdon1@gmail.com
Contact: Alice Liu, BA 4084253539 alicejliu95@gmail.com

Sponsors and Collaborators
Sun Yat-sen University
Wenzhou Medical University
Investigators
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Principal Investigator: 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
  Study Documents (Full-Text)

Documents provided by Congdon Nathan, Sun Yat-sen University:

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Responsible Party: Congdon Nathan, Principal Investigator, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03958929     History of Changes
Other Study ID Numbers: 2019-074-K-73
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Congdon Nathan, Sun Yat-sen University:
glaucoma surgery
educational intervention
satisfaction
rural
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases