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Information, Networks and Rewards to Optimise Adherence to Diabetic Services (INROADS)

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ClinicalTrials.gov Identifier: NCT03804970
Recruitment Status : Not yet recruiting
First Posted : January 15, 2019
Last Update Posted : January 15, 2019
Sponsor:
Collaborator:
Yangxi people hospital, Yangjiang, Guangdong Province
Information provided by (Responsible Party):
Congdon Nathan, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE January 8, 2019
First Posted Date  ICMJE January 15, 2019
Last Update Posted Date January 15, 2019
Estimated Study Start Date  ICMJE January 15, 2019
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2019)
Proportion of scheduled eye care visits attended over 1 year [ Time Frame: One year ]
The visits will be recorded during the 1 year
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2019)
  • Follow-up HbA1c [ Time Frame: One year ]
    This outcome will be recorded in the baseline and end-line examination
  • Proportion of scheduled endocrine care visits attended over 1 year [ Time Frame: One year ]
    The outcome will be recorded during the 1 year
  • Retinopathy grade in the better seeing eye. [ Time Frame: One year ]
    This outcome will be recorded in the baseline and end-line examination
  • Visual acuity in the better seeing eye. [ Time Frame: One year ]
    This outcome will be recorded in the baseline and end-line examination
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Information, Networks and Rewards to Optimise Adherence to Diabetic Services
Official Title  ICMJE Information, Networks and Rewards to Optimise Adherence to Diabetic Services: "INROADS in China": A Randomized Trial
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.
Detailed Description

Background: Diabetes affects some 10% of rural-dwellers in southern China. Demand for care of both diabetes and DR is low in this population: Only 25% are in care for diabetes (vs 100% of a matched urban cohort), 0% were being treated for DR (vs 55% of the urban cohort) and 31% said they were likely/very likely to accept diabetic eyecare when it was described to them (vs 78% of the urban group). A simple intervention of informational SMS reminders could significantly increase knowledge about DR and satisfaction with care among rural dwellers, while tripling their compliance with scheduled eye examinations. However, even in the group receiving the SMS reminders, over half failed to present for exams. More effective interventions are needed.

Participants: All the participants with treated diabetes or HbA1c >=6.5% from the Guangdong (Yangjiang) centre of our population-based Rural Diabetic Eye Disease Survey. 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), and be capable of giving informed consent.

Randomisation: To avoid contamination, we are clustering recruitment and randomisation at the level of village and inviting participants in the two study groups to the Yangjiang eye screening centre for follow-up on different clinic days. Block randomization, at village level, will be balanced by the distribution of education levels and travel times from screening centre.

Intervention. All groups will be offered a brief video, already created and piloted, explaining basic information about diabetes and diabetic eye disease. The Intervention group will also receive (i) non-cash rewards (free eye care and modest mobile phone top ups in return for attendance at retinopathy screenings), the value of which will increase with the risk of vision loss (based on existing level of eye disease and HbA1c). (ii) Informational reminders delivered by SMS text 1 day and 1 week prior to scheduled eye exams. In keeping with health economic research,3 the reminders will emphasize anticipated regret: "Your next eye screening visit is next week, on dd/mm/yy. If you miss your eye screening visit, you might regret this if you subsequently lose your vision."; and (iii) peer and village health worker (VHW) networking (supported by the existing Orbis CREST project). Peer supporters will be a nominated family member or friend who has regular contact with the patient and a VHW or a community member with diabetes who has been trained to run monthly group educational sessions in the local village on optimum self-care and self-management of diabetes/DR. An important function of the family member or peer supporter is also to re-inforce the SMS informational reminders before the scheduled clinic visit.

Primary outcome measure: Proportion of scheduled eye care visits attended over 1 year. Secondary outcomes, not the direct target of our intervention, but which might be improved by a behavioural spill-over effect, will include: follow-up HbA1c; medication adherence; retinopathy grade and visual acuity in the better seeing eye.

Power and sample size: Assuming an effect size d= 0.44, and an attrition of 15% over two years, a full trial of 412 patients (42 villages in each of the two groups and 206 patients per group) would have 90% power (two sided alpha error 0.05).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE Diabetes
Intervention  ICMJE
  • Behavioral: cash rewards for the fellow up
    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.
  • Behavioral: Showing retinal photos to participants
    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.
  • Behavioral: SMS reminders for participants and their family
    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.
  • Behavioral: Watching brief video and basic explanation for disease
    This basic explanation will be offered by professional doctors or nurses.
  • Behavioral: Having the Diabetic Club
    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.
Study Arms  ICMJE
  • Experimental: Intervention group
    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
    Interventions:
    • Behavioral: cash rewards for the fellow up
    • Behavioral: Showing retinal photos to participants
    • Behavioral: SMS reminders for participants and their family
    • Behavioral: Having the Diabetic Club
  • Experimental: Adjusted intervention group
    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)
    Interventions:
    • Behavioral: cash rewards for the fellow up
    • Behavioral: Showing retinal photos to participants
    • Behavioral: SMS reminders for participants and their family
    • Behavioral: Having the Diabetic Club
  • Active Comparator: Control group
    Watching brief video and basic explanation for disease
    Intervention: Behavioral: Watching brief video and basic explanation for disease
Publications *

*   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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 14, 2019)
225
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2020
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Have other serious eye disease;
  • Have mobility limitations precluding routine clinic visits or bilateral blindness (<6/120).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nathan Congdon, MD 86-020-87682342 ncongdon1@gmail.com
Contact: Congyao Wang +8613660367294 wangcongyao09@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03804970
Other Study ID Numbers  ICMJE ZOC-INROADS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Congdon Nathan, Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Yangxi people hospital, Yangjiang, Guangdong Province
Investigators  ICMJE
Principal Investigator: Nathan Congdon, MD Zongshan Ophthalmic Center
Principal Investigator: Wenyong Huang, MD Zongshan Ophthalmic Center
Study Director: Chunhui Chen Yangxi People hospital, Guangdong
Study Chair: Congyao Wang Zongshan Ophthalmic Center
PRS Account Sun Yat-sen University
Verification Date January 2019

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