Overview

This trial is active, not recruiting.

Condition glaucoma
Treatments film and trained counseling, traditional counseling
Sponsor Sun Yat-sen University
Start date December 2012
End date December 2013
Trial size 356 participants
Trial identifier NCT01726569, ZOC-CREST1

Summary

1. Investigate degree of postoperative satisfaction in county level hospital glaucoma patients.

2. Investigate the effect of educational intervention affect the degree of satisfaction in glaucoma patients.

3. Investigate the effect factors of postoperative satisfaction.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Subjects will be asked to watch a 5-10 min film and participate in a 10-15 min pre-operative counseling session with a trained doctor/nurse. Subjects will also participate in a 5 min post-operative counseling session and follow up counseling after operation 1 week and 6 weeks
film and trained counseling
Subjects will be asked to watch a 5-10 min film and participate in a 10-15 min pre-operative counseling session with a trained doctor/nurse. Subjects will also participate in a 5 min post-operative counseling session.
traditional counseling
Subjects will be not participate or participate in a pre-operative/post-operative counseling session with a rural hospital's doctor/nurse as usual traditional methods.
(Other)
Subjects will be participate or not participate in pre-operative counseling and/or post-operative counseling with a rural hospital's doctor/nurse.
traditional counseling
Subjects will be not participate or participate in a pre-operative/post-operative counseling session with a rural hospital's doctor/nurse as usual traditional methods.

Primary Outcomes

Measure
postoperative satisfaction rate in both group
time frame: after surgery up to 6 weeks

Secondary Outcomes

Measure
knowledge about glaucoma
time frame: before surgery and after surgey 1 week and 6 weeks
willingness to recommend surgery
time frame: after surgery 1 week and 6 weeks
personality in both groups
time frame: Baseline (before surgery)
intraocular pressure and visual acuity in both groups
time frame: before surgery and after surgery 1week and 6 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Randomized Trial of the Impact of Multifaceted Education on Post-operative Satisfaction With Glaucoma Surgery in Rural China
Principal investigator Nathan Congdon, MD,MPH
Description Glaucoma is the leading cause irreversible blindness worldwide, but only less than 10% glaucoma patients were diagnosed in the country of Asia areas. In the country of China, patients who are low educational level and less known acknowledgement and information have less known glaucoma. In the help of the government and some international non-governmental organizations(NGOs), a lot of people in the country know the cataract, and the operability of cataract is increase. Because vision loss usually development after operation for glaucoma. If patients did not understand this, they may be not only do not accept operation, but also affect operability of cataract. We hope the educational intervention for glaucoma can increase the degree of satisfaction in glaucoma patients.
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by Sun Yat-sen University.