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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

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.

Condition or disease Intervention/treatment Phase
Diabetes Behavioral: cash rewards for the fellow up Behavioral: Showing retinal photos to participants Behavioral: SMS reminders for participants and their family Behavioral: Watching brief video and basic explanation for disease Behavioral: Having the Diabetic Club Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Information, Networks and Rewards to Optimise Adherence to Diabetic Services: "INROADS in China": A Randomized Trial
Estimated Study Start Date : January 15, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : August 30, 2020

Arm Intervention/treatment
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
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: 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.

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)
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: 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.

Active Comparator: Control group
Watching brief video and basic explanation for disease
Behavioral: Watching brief video and basic explanation for disease
This basic explanation will be offered by professional doctors or nurses.




Primary Outcome Measures :
  1. Proportion of scheduled eye care visits attended over 1 year [ Time Frame: One year ]
    The visits will be recorded during the 1 year


Secondary Outcome Measures :
  1. Follow-up HbA1c [ Time Frame: One year ]
    This outcome will be recorded in the baseline and end-line examination

  2. Proportion of scheduled endocrine care visits attended over 1 year [ Time Frame: One year ]
    The outcome will be recorded during the 1 year

  3. Retinopathy grade in the better seeing eye. [ Time Frame: One year ]
    This outcome will be recorded in the baseline and end-line examination

  4. Visual acuity in the better seeing eye. [ Time Frame: One year ]
    This outcome will be recorded in the baseline and end-line examination



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03804970


Contacts
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Contact: Nathan Congdon, MD 86-020-87682342 ncongdon1@gmail.com
Contact: Congyao Wang +8613660367294 wangcongyao09@163.com

Locations
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China, Guangdong
Yangxi hospital
Yangjiang, Guangdong, China
Sponsors and Collaborators
Sun Yat-sen University
Yangxi people hospital, Yangjiang, Guangdong Province
Investigators
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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

Publications:
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Responsible Party: Congdon Nathan, Professor of Preventative Ophthalmology, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03804970     History of Changes
Other Study ID Numbers: ZOC-INROADS
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Congdon Nathan, Sun Yat-sen University:
Diabetes
follow-up
Diabetic retinopathy
Diabetic teaching
SMS
rewards