- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01837121
a Trial of Using SMS Reminder Among Diabetic Retinopathy Patients in Rural China (SMS)
January 7, 2018 updated by: Congdon Nathan, Sun Yat-sen University
a Randomized Controlled Trail to Determine the Impact of a SMS Reminder Among Diabetic Retinopathy Patients in Rural China
The purpose of this study is to use a randomized controlled design to determine the impact of a SMS messaging intervention on the following outcomes among persons diagnosed with diabetic retinopathy in rural China.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 diabetic retinopathy patients.
Study Type
Interventional
Enrollment (Actual)
237
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
Guangdong
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Guangzhou, Guangdong, China, 510060
- Blindness Preventment and Treatment Department, Zhongshan Ophthalmic Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- all the diabetes patients who would like to join our study in 5 CREST 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.
- The first re-visit appointment time is outside our study period.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: the SMS group
the diabetic retinopathy patient in the SMS group will receive a SMS reminder message about the revisit time,address 1 week and 3 day before the appointment.
|
the SMS reminder message will sent to the SMS group patients 1 week and 3 day before there appointment,to remind them the exact time and address of the revisit appointment.
|
|
No Intervention: the control group
the diabetic retinopathy patient in the control group won't get any reminder message before the appointment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Not-attended rate
Time Frame: up to 1.5 years
|
Compare the SMS patient not-attended rate with the control group to show the impact of SMS reminder on the compliance with scheduled follow-up visit
|
up to 1.5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge about Diabetic retinopathy on a standardized examination
Time Frame: up to 1.5 years
|
Using a questionnaire about the comprehensive eye exam and Diabetic retinopathy to compare Knowledge about Diabetic retinopathy on a standardized examination between the SMS group and the control group
|
up to 1.5 years
|
|
Presenting vision
Time Frame: up to 1.5 years
|
Presenting vision(Best corrected visual acuity) in the better-seeing and worse-seeing eyes of the two group
|
up to 1.5 years
|
|
Loss of presenting vision
Time Frame: up to 1.5 years
|
Loss of presenting vision(Best corrected visual acuity) in better-seeing eye thought due to Diabetic retinopathy
|
up to 1.5 years
|
|
Satisfaction with care
Time Frame: up tp 1.5 years
|
Using a patient satisfaction questionnaire to compare satisfaction with care between the SMS group and the control group
|
up tp 1.5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Nathan G Congdon, MD,MPH, Blindness Prevention and Treament Department,Zhongshan Ophthalmic Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
April 14, 2013
First Submitted That Met QC Criteria
April 17, 2013
First Posted (Estimate)
April 22, 2013
Study Record Updates
Last Update Posted (Actual)
January 9, 2018
Last Update Submitted That Met QC Criteria
January 7, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZOC-WDF-SMS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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