Back to resultsEffect of SMS Reminder and Free Eye Drops on Follow-up Adherence After Trabeculectomy Surgery in Rural China
Primary Purpose
Glaucoma, Adherence
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SMS and free eye drops
Sponsored by
About this trial
This is an interventional health services research trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- All the patients after trabeculectomy surgery in 4 cooperated rural hospitals
Exclusion Criteria:
- Both the patient and his/her caretakers don't have cellphone or the one who has cellphone but don't know how to use the SMS function.
Sites / Locations
- Blindness Preventment and Treatment Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
SMS and free eye drops group
the control group
Arm Description
the patient after trabeculectomy surgery in the SMS associated with free eye drops group will receive free eye drops and a SMS reminder message about the revisit time.
the patient after trabeculectomy surgery in the control group won't get any free eye drop and reminder message before the appointment.
Outcomes
Primary Outcome Measures
Not-attended rate
Compare the SMS and free eye drops patient not-attend rate with the control group to show the impact of SMS reminder associated with free eye drops on the adherence with scheduled follow-up visit
Secondary Outcome Measures
Knowledge and Attitudes about glaucoma, glaucoma surgery and importance of follow-up using a questionnaire
Using a questionnaire to compare Knowledge and Attitude between the SMS associated with free eye drops group and the control group
Additional factors potentially associated with post-operative follow-up using a patient questionnaire
Using a patient questionnaire to compare between the SMS associated with free eye drops group and the control group
Full Information
NCT ID
NCT02328456
First Posted
December 23, 2014
Last Updated
April 14, 2016
Sponsor
Congdon Nathan
Collaborators
Orbis
1. Study Identification
Unique Protocol Identification Number
NCT02328456
Brief Title
Effect of SMS Reminder and Free Eye Drops on Follow-up Adherence After Trabeculectomy Surgery in Rural China
Official Title
A Randomized Controlled Trail to Determine the Impact of a SMS Reminder Associated With Free Eye Drops on Follow-up Adherence After Trabeculectomy Surgery in Rural China
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Congdon Nathan
Collaborators
Orbis
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to use a randomized controlled design to determine the impact of a SMS messaging associated with free eye drops intervention on the following outcomes among patients after trabeculectomy surgery in rural China.
Detailed Description
SMS message reminder is a system which can sent re-visit information to remind the patient about the revisit time and address. The investigators can use the SMS system to find out if it is a useful to reduce the not-attended rate of the revisit appointment among the rural patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Adherence
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
209 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SMS and free eye drops group
Arm Type
Other
Arm Description
the patient after trabeculectomy surgery in the SMS associated with free eye drops group will receive free eye drops and a SMS reminder message about the revisit time.
Arm Title
the control group
Arm Type
No Intervention
Arm Description
the patient after trabeculectomy surgery in the control group won't get any free eye drop and reminder message before the appointment.
Intervention Type
Other
Intervention Name(s)
SMS and free eye drops
Intervention Description
The SMS reminder message will sent to the SMS associated with free eye drops group patients 1 week and 1 day before there appointment to remind them the exact time and address of the revisit appointment.The eye drops will be offered free to the the SMS associated with free eye drops group patients when they revisit on time.
Primary Outcome Measure Information:
Title
Not-attended rate
Description
Compare the SMS and free eye drops patient not-attend rate with the control group to show the impact of SMS reminder associated with free eye drops on the adherence with scheduled follow-up visit
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
Knowledge and Attitudes about glaucoma, glaucoma surgery and importance of follow-up using a questionnaire
Description
Using a questionnaire to compare Knowledge and Attitude between the SMS associated with free eye drops group and the control group
Time Frame
up to 1 year
Title
Additional factors potentially associated with post-operative follow-up using a patient questionnaire
Description
Using a patient questionnaire to compare between the SMS associated with free eye drops group and the control group
Time Frame
up to 1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All the patients after trabeculectomy surgery in 4 cooperated rural hospitals
Exclusion Criteria:
Both the patient and his/her caretakers don't have cellphone or the one who has cellphone but don't know how to use the SMS function.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathan G Congdon, MD,MPH
Organizational Affiliation
China,Guangdong,Blindness Preventment and Treatment Department,Zhongshan Ophthalmic Center,510060
Official's Role
Study Director
Facility Information:
Facility Name
Blindness Preventment and Treatment Department
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27541442
Citation
Yang K, Jin L, Li L, Zeng S, Wei R, Li G, Man P, Congdon N. Interventions to Promote Follow-up After Trabeculectomy Surgery in Rural Southern China: A Randomized Clinical Trial. JAMA Ophthalmol. 2016 Oct 1;134(10):1135-1141. doi: 10.1001/jamaophthalmol.2016.2819.
Results Reference
derived
Learn more about this trial
Effect of SMS Reminder and Free Eye Drops on Follow-up Adherence After Trabeculectomy Surgery in Rural China
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