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AzTrials

DiabetesINROADSNCT03804970

Information, Networks and Rewards to Optimise Adherence to Diabetic Services

A study testing cash rewards for the fellow up, Showing retinal photos to participants and SMS reminders for participants and their family in people with Diabetes, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Diabetes
What is being tested?
cash rewards for the fellow up, Showing retinal photos to participants and SMS reminders for participants and their family
Could I receive a placebo?
No, everyone receives an active treatment
How many people
225 participants
Where
1 siteChina
Study dates
15 Aug 2019to 30 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site
  • Yangxi hospital

    Yangjiang, Guangdong

Other trials in China

About this study

Official title: Information, Networks and Rewards to Optimise Adherence to Diabetic Services: "INROADS in China": A Randomized Trial

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.

Read the 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).

Conditions
Diabetes
Being tested
cash rewards for the fellow up, Showing retinal photos to participants, SMS reminders for participants and their family, Watching brief video and basic explanation for disease, Having the Diabetic Club
Keywords
Diabetes, follow-up, Diabetic retinopathy, Diabetic teaching, SMS, rewards
Medical subject headings
Diabetes Mellitus, Diabetic Retinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cash rewards for the fellow upBehavioural

    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.

  • Showing retinal photos to participantsBehavioural

    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.

  • SMS reminders for participants and their familyBehavioural

    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.

  • Watching brief video and basic explanation for diseaseBehavioural

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

  • Having the Diabetic ClubBehavioural

    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 groups in NCT03804970
Study groupRoleWhat they receive
Intervention groupExperimentalCash 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
Receives: 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
Adjusted intervention groupExperimentalCash 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)
Receives: 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
Control groupActive comparatorWatching brief video and basic explanation for disease
Receives: Behavioral: Watching brief video and basic explanation for disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of scheduled eye care visits attended over 1 year

    The visits will be recorded during the 1 year

    Measured: One year

Secondary outcomes (4)
  1. Follow-up HbA1c

    This outcome will be recorded in the baseline and end-line examination

    Measured: One year

  2. Proportion of scheduled endocrine care visits attended over 1 year

    The outcome will be recorded during the 1 year

    Measured: One year

  3. Retinopathy grade in the better seeing eye.

    This outcome will be recorded in the baseline and end-line examination

    Measured: One year

  4. Visual acuity in the better seeing eye.

    This outcome will be recorded in the baseline and end-line examination

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2019
  2. Study start15 Aug 2019
  3. Primary completion30 Aug 2020
  4. Study completion30 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
225 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03804970
Sponsor's protocol ID
ZOC-INROADS
Acronym
INROADS
Status last verified
Jan 2019
First submitted
8 Jan 2019
Last updated
19 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30357401
  • 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.

    PubMed 30053472
  • 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.

    PubMed 21639637
  • 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.

    PubMed 12399340

Questions about this trial

What is this clinical trial studying?

A study testing cash rewards for the fellow up, Showing retinal photos to participants and SMS reminders for participants and their family in people with Diabetes, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of scheduled eye care visits attended over 1 year (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03804970, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.

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