NCT01837121

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
237

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 22, 2013

Completed
1.7 years until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

2.4 years

First QC Date

April 14, 2013

Last Update Submit

January 7, 2018

Conditions

Keywords

not-attended ratere-visitvisionknowledgesatisfaction

Outcome Measures

Primary Outcomes (1)

  • Not-attended rate

    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 Outcomes (4)

  • Knowledge about Diabetic retinopathy on a standardized examination

    up to 1.5 years

  • Presenting vision

    up to 1.5 years

  • Loss of presenting vision

    up to 1.5 years

  • Satisfaction with care

    up tp 1.5 years

Study Arms (2)

the SMS group

OTHER

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.

Other: the SMS reminder message

the control group

NO INTERVENTION

the diabetic retinopathy patient in the control group won't get any reminder message before the appointment.

Interventions

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.

the SMS group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Blindness Preventment and Treatment Department, Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Patient ComplianceDiabetic RetinopathyPersonal Satisfaction

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Nathan G Congdon, MD,MPH

    Blindness Prevention and Treament Department,Zhongshan Ophthalmic Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice director,Blindness Prevention and Treatment Department

Study Record Dates

First Submitted

April 14, 2013

First Posted

April 22, 2013

Study Start

January 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

January 9, 2018

Record last verified: 2018-01

Locations