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a Trial of Using SMS Reminder Among Diabetic Retinopathy Patients in Rural China (SMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01837121
Recruitment Status : Completed
First Posted : April 22, 2013
Last Update Posted : January 9, 2018
Sponsor:
Collaborators:
Orbis
The World Diabetes Foundation
Information provided by (Responsible Party):
Congdon Nathan, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE April 14, 2013
First Posted Date  ICMJE April 22, 2013
Last Update Posted Date January 9, 2018
Actual Study Start Date  ICMJE January 2015
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2018)		 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
Original Primary Outcome Measures  ICMJE
 (submitted: April 17, 2013)		 Not-attended rate [ Time Frame: up to 3 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2018)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2013)
  • Knowledge about Diabetic retinopathy on a standardized examination [ Time Frame: up to 3 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
  • Presenting vision [ Time Frame: up to 3 years ]
    Presenting vision in the better-seeing and worse-seeing eyes of the two group
  • Loss of presenting vision [ Time Frame: up to 3 years ]
    Loss of two or more lines of presenting vision in better-seeing eye thought due to Diabetic retinopathy
  • Satisfaction with care [ Time Frame: up tp 3 years ]
    Using a patient satisfaction questionnaire to compare satisfaction with care between the SMS group and the control group
  • Number of treatments received for Diabetic retinopathy [ Time Frame: up to 3 years ]
    Compare Number of treatment received for Diabetic retinopathy between the SMS group and the control group to show if the SMS reminder increase the number of treatments
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE a Trial of Using SMS Reminder Among Diabetic Retinopathy Patients in Rural China
Official Title  ICMJE a Randomized Controlled Trail to Determine the Impact of a SMS Reminder Among Diabetic Retinopathy Patients in Rural China
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Compliance
  • Diabetic Retinopathy
  • SMS
Intervention  ICMJE Other: the SMS reminder message
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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: the SMS reminder message
  • No Intervention: the control group
    the diabetic retinopathy patient in the control group won't get any reminder message before the appointment.
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 Completed
Actual Enrollment  ICMJE
 (submitted: January 7, 2018)		 237
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2013)		 5000
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- all the diabetes patients who would like to join our study in 5 CREST cooperated rural hospitals.

Exclusion Criteria:

  1. 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.
  2. The first re-visit appointment time is outside our study period.
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01837121
Other Study ID Numbers  ICMJE ZOC-WDF-SMS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Congdon Nathan, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE
  • Orbis
  • The World Diabetes Foundation
Investigators  ICMJE
Study Director: Nathan G Congdon, MD,MPH Blindness Prevention and Treament Department,Zhongshan Ophthalmic Center
PRS Account Sun Yat-sen University
Verification Date January 2018

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