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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

Tracking Information
First Submitted Date  ICMJE May 20, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date May 22, 2019
Estimated Study Start Date  ICMJE June 2019
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • The rate of willingness to recommend surgery to a friend or relative with glaucoma [ Time Frame: 1 day, 1 week ]
    The measurement method: questionnaire
  • 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.
  • 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.
  • Intraocular pressure in both groups [ Time Frame: Baseline (before surgery); 1 day and 1 week after surgery ]
    Unit of Intraocular pressure is mmHg.
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • The rate of willingness to recommend surgery to a friend or relative with glaucoma [ Time Frame: 1 day, 1 week ]
    The measurement method: questionnaire
  • Personality in both groups using Eysenck Personality Questionnaire-Revised Short Scale for Chinese (EPQ-RSC) access glaucoma patients personality [ Time Frame: Baseline (before surgery) ]
  • Knowledge scores about glaucoma [ Time Frame: Baseline (before surgery); 1 day and 1 week after surgery ]
  • Intraocular pressure in both groups [ Time Frame: Baseline (before surgery); 1 day and 1 week after surgery ]
    Unit of Intraocular pressure is mmHg.
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of an Educational Video on Satisfaction After Glaucoma Surgery
Official Title  ICMJE A Randomized Controlled Trial on the Impact of an Educational Video on Satisfaction After Glaucoma Surgery in Urban and Rural China
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Glaucoma
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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).
    Intervention: Other: Educational Video
  • 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..
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 21, 2019)
264
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nathan Congdon, MD,MPH +8602087682342 ncongdon1@gmail.com
Contact: Alice Liu, BA 4084253539 alicejliu95@gmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03958929
Other Study ID Numbers  ICMJE 2019-074-K-73
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Congdon Nathan, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Wenzhou Medical University
Investigators  ICMJE
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
PRS Account Sun Yat-sen University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP