NCT03804970

Brief Summary

This prospective, randomised controlled trial is to investigate whether the complex intervention, including incentives (inexpensive cellphone top-ups), information (viewing one's own fundus photos and receiving SMS informational reminders) and peer support (Diabetes clubs), improve compliance with eye care among rural persons living with diabetes in southern China.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
225

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Aug 2019

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

January 8, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

August 15, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

March 19, 2021

Status Verified

January 1, 2019

Enrollment Period

1 year

First QC Date

January 8, 2019

Last Update Submit

March 18, 2021

Conditions

Diabetes

Keywords

Diabetesfollow-upDiabetic retinopathyDiabetic teachingSMSrewards

Outcome Measures

Primary Outcomes (1)

  • Proportion of scheduled eye care visits attended over 1 year

    The visits will be recorded during the 1 year

    One year

Secondary Outcomes (4)

  • Follow-up HbA1c

    One year

  • Proportion of scheduled endocrine care visits attended over 1 year

    One year

  • Retinopathy grade in the better seeing eye.

    One year

  • Visual acuity in the better seeing eye.

    One year

Study Arms (3)

Intervention group

EXPERIMENTAL

Cash rewards for the fellow up+SMS reminders for participants and their family+Showing retinal photos to participants+ Having the Diabetic Club+Watching brief video and basic explanation for disease

Behavioral: cash rewards for the fellow upBehavioral: Showing retinal photos to participantsBehavioral: SMS reminders for participants and their familyBehavioral: Having the Diabetic Club

Adjusted intervention group

EXPERIMENTAL

Cash rewards for the fellow up+SMS reminders for participants and their family+Showing retinal photos to participants+Having the Diabetic Club+Watching brief video and basic explanation for disease( But the intensity of intervention based on the severity of diabetic disease)

Behavioral: cash rewards for the fellow upBehavioral: Showing retinal photos to participantsBehavioral: SMS reminders for participants and their familyBehavioral: Having the Diabetic Club

Control group

ACTIVE COMPARATOR

Watching brief video and basic explanation for disease

Behavioral: Watching brief video and basic explanation for disease

Interventions

cash rewards for the fellow upBEHAVIORAL

This is a multiple stimulus intervention study, and there are two intervention groups. One is the normal intervention group, and the other is the adjusted intervention group. The intensity of intervention in the latter group is based on the severity of diabetic disease.

Adjusted intervention groupIntervention group
Showing retinal photos to participantsBEHAVIORAL

This is a multiple stimulus intervention study, and there are two intervention groups. One is the normal intervention group, and the other is the adjusted intervention group. The intensity of intervention in the latter group is based on the severity of diabetic disease.

Adjusted intervention groupIntervention group
SMS reminders for participants and their familyBEHAVIORAL

This is a multiple stimulus intervention study, and there are two intervention groups. One is the normal intervention group, and the other is the adjusted intervention group. The intensity of intervention in the latter group is based on the severity of diabetic disease.

Adjusted intervention groupIntervention group
Watching brief video and basic explanation for diseaseBEHAVIORAL

This basic explanation will be offered by professional doctors or nurses.

Control group
Having the Diabetic ClubBEHAVIORAL

This is a multiple stimulus intervention study, and there are two intervention groups. One is the normal intervention group, and the other is the adjusted intervention group. The intensity of intervention in the latter group is based on the severity of diabetic disease.

Adjusted intervention groupIntervention group

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • They must be aged 50-90 years;
  • Own a cell phone (ownership is \> 95% in the area);
  • Have no mobility limitations precluding routine clinic visits or bilateral blindness (\<6/120);
  • Be capable of giving informed consent.

You may not qualify if:

  • Have other serious eye disease;
  • Have mobility limitations precluding routine clinic visits or bilateral blindness (\<6/120).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yangxi hospital

Yangjiang, Guangdong, China

Location

Related Publications (4)

  • Jin G, Xiao W, Ding X, Xu X, An L, Congdon N, Zhao J, He M. Prevalence of and Risk Factors for Diabetic Retinopathy in a Rural Chinese Population: The Yangxi Eye Study. Invest Ophthalmol Vis Sci. 2018 Oct 1;59(12):5067-5073. doi: 10.1167/iovs.18-24280.

    PMID: 30357401BACKGROUND

  • Chen T, Zhu W, Tang B, Jin L, Fu H, Chen Y, Wang C, Zhang G, Wang J, Ye T, Xiao D, Vignarajan J, Xiao B, Kanagasingam Y, Congdon N. A Mobile Phone Informational Reminder to Improve Eye Care Adherence Among Diabetic Patients in Rural China: A Randomized Controlled Trial. Am J Ophthalmol. 2018 Oct;194:54-62. doi: 10.1016/j.ajo.2018.07.006. Epub 2018 Jul 24.

    PMID: 30053472BACKGROUND

  • Whitaker KL, Good A, Miles A, Robb K, Wardle J, von Wagner C. Socioeconomic inequalities in colorectal cancer screening uptake: does time perspective play a role? Health Psychol. 2011 Nov;30(6):702-9. doi: 10.1037/a0023941. Epub 2011 May 30.

    PMID: 21639637BACKGROUND

  • Weingarten SR, Henning JM, Badamgarav E, Knight K, Hasselblad V, Gano A Jr, Ofman JJ. Interventions used in disease management programmes for patients with chronic illness-which ones work? Meta-analysis of published reports. BMJ. 2002 Oct 26;325(7370):925. doi: 10.1136/bmj.325.7370.925.

    PMID: 12399340BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusDiabetic Retinopathy

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes Complications

Study Officials

  • Nathan Congdon, MD

    Zongshan Ophthalmic Center

    PRINCIPAL INVESTIGATOR

  • Wenyong Huang, MD

    Zongshan Ophthalmic Center

    PRINCIPAL INVESTIGATOR

  • Chunhui Chen

    Yangxi People hospital, Guangdong

    STUDY DIRECTOR

  • Congyao Wang

    Zongshan Ophthalmic Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Preventative Ophthalmology

Study Record Dates

First Submitted

January 8, 2019

First Posted

January 15, 2019

Study Start

August 15, 2019

Primary Completion

August 30, 2020

Study Completion

December 30, 2020

Last Updated

March 19, 2021

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)