<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03804970</url>
  </required_header>
  <id_info>
    <org_study_id>ZOC-INROADS</org_study_id>
    <nct_id>NCT03804970</nct_id>
  </id_info>
  <brief_title>Information, Networks and Rewards to Optimise Adherence to Diabetic Services</brief_title>
  <acronym>INROADS</acronym>
  <official_title>Information, Networks and Rewards to Optimise Adherence to Diabetic Services: &quot;INROADS in China&quot;: A Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Yangxi people hospital, Yangjiang, Guangdong Province</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective, randomised controlled trial is to investigate whether the complex&#xD;
      intervention, including incentives (inexpensive cellphone top-ups), information (viewing&#xD;
      one's own fundus photos and receiving SMS informational reminders) and peer support (Diabetes&#xD;
      clubs), improve compliance with eye care among rural persons living with diabetes in southern&#xD;
      China.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Diabetes affects some 10% of rural-dwellers in southern China. Demand for care of&#xD;
      both diabetes and DR is low in this population: Only 25% are in care for diabetes (vs 100% of&#xD;
      a matched urban cohort), 0% were being treated for DR (vs 55% of the urban cohort) and 31%&#xD;
      said they were likely/very likely to accept diabetic eyecare when it was described to them&#xD;
      (vs 78% of the urban group). A simple intervention of informational SMS reminders could&#xD;
      significantly increase knowledge about DR and satisfaction with care among rural dwellers,&#xD;
      while tripling their compliance with scheduled eye examinations. However, even in the group&#xD;
      receiving the SMS reminders, over half failed to present for exams. More effective&#xD;
      interventions are needed.&#xD;
&#xD;
      Participants: All the participants with treated diabetes or HbA1c &gt;=6.5% from the Guangdong&#xD;
      (Yangjiang) centre of our population-based Rural Diabetic Eye Disease Survey. They must be&#xD;
      aged 50-90 years, own a cell phone (ownership is &gt; 95% in the area), have no mobility&#xD;
      limitations precluding routine clinic visits or bilateral blindness (&lt;6/120), and be capable&#xD;
      of giving informed consent.&#xD;
&#xD;
      Randomisation: To avoid contamination, we are clustering recruitment and randomisation at the&#xD;
      level of village and inviting participants in the two study groups to the Yangjiang eye&#xD;
      screening centre for follow-up on different clinic days. Block randomization, at village&#xD;
      level, will be balanced by the distribution of education levels and travel times from&#xD;
      screening centre.&#xD;
&#xD;
      Intervention. All groups will be offered a brief video, already created and piloted,&#xD;
      explaining basic information about diabetes and diabetic eye disease. The Intervention group&#xD;
      will also receive (i) non-cash rewards (free eye care and modest mobile phone top ups in&#xD;
      return for attendance at retinopathy screenings), the value of which will increase with the&#xD;
      risk of vision loss (based on existing level of eye disease and HbA1c). (ii) Informational&#xD;
      reminders delivered by SMS text 1 day and 1 week prior to scheduled eye exams. In keeping&#xD;
      with health economic research,3 the reminders will emphasize anticipated regret: &quot;Your next&#xD;
      eye screening visit is next week, on dd/mm/yy. If you miss your eye screening visit, you&#xD;
      might regret this if you subsequently lose your vision.&quot;; and (iii) peer and village health&#xD;
      worker (VHW) networking (supported by the existing Orbis CREST project). Peer supporters will&#xD;
      be a nominated family member or friend who has regular contact with the patient and a VHW or&#xD;
      a community member with diabetes who has been trained to run monthly group educational&#xD;
      sessions in the local village on optimum self-care and self-management of diabetes/DR. An&#xD;
      important function of the family member or peer supporter is also to re-inforce the SMS&#xD;
      informational reminders before the scheduled clinic visit.&#xD;
&#xD;
      Primary outcome measure: Proportion of scheduled eye care visits attended over 1 year.&#xD;
      Secondary outcomes, not the direct target of our intervention, but which might be improved by&#xD;
      a behavioural spill-over effect, will include: follow-up HbA1c; medication adherence;&#xD;
      retinopathy grade and visual acuity in the better seeing eye.&#xD;
&#xD;
      Power and sample size: Assuming an effect size d= 0.44, and an attrition of 15% over two&#xD;
      years, a full trial of 412 patients (42 villages in each of the two groups and 206 patients&#xD;
      per group) would have 90% power (two sided alpha error 0.05).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2019</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">August 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of scheduled eye care visits attended over 1 year</measure>
    <time_frame>One year</time_frame>
    <description>The visits will be recorded during the 1 year</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Follow-up HbA1c</measure>
    <time_frame>One year</time_frame>
    <description>This outcome will be recorded in the baseline and end-line examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of scheduled endocrine care visits attended over 1 year</measure>
    <time_frame>One year</time_frame>
    <description>The outcome will be recorded during the 1 year</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retinopathy grade in the better seeing eye.</measure>
    <time_frame>One year</time_frame>
    <description>This outcome will be recorded in the baseline and end-line examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual acuity in the better seeing eye.</measure>
    <time_frame>One year</time_frame>
    <description>This outcome will be recorded in the baseline and end-line examination</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">225</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adjusted intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Watching brief video and basic explanation for disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>cash rewards for the fellow up</intervention_name>
    <description>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.</description>
    <arm_group_label>Adjusted intervention group</arm_group_label>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Showing retinal photos to participants</intervention_name>
    <description>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.</description>
    <arm_group_label>Adjusted intervention group</arm_group_label>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SMS reminders for participants and their family</intervention_name>
    <description>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.</description>
    <arm_group_label>Adjusted intervention group</arm_group_label>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Watching brief video and basic explanation for disease</intervention_name>
    <description>This basic explanation will be offered by professional doctors or nurses.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Having the Diabetic Club</intervention_name>
    <description>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.</description>
    <arm_group_label>Adjusted intervention group</arm_group_label>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  They must be aged 50-90 years;&#xD;
&#xD;
          -  Own a cell phone (ownership is &gt; 95% in the area);&#xD;
&#xD;
          -  Have no mobility limitations precluding routine clinic visits or bilateral blindness&#xD;
             (&lt;6/120);&#xD;
&#xD;
          -  Be capable of giving informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have other serious eye disease;&#xD;
&#xD;
          -  Have mobility limitations precluding routine clinic visits or bilateral blindness&#xD;
             (&lt;6/120).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nathan Congdon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zongshan Ophthalmic Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wenyong Huang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zongshan Ophthalmic Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chunhui Chen</last_name>
    <role>Study Director</role>
    <affiliation>Yangxi People hospital, Guangdong</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Congyao Wang</last_name>
    <role>Study Chair</role>
    <affiliation>Zongshan Ophthalmic Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yangxi hospital</name>
      <address>
        <city>Yangjiang</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>30357401</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>30053472</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21639637</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>12399340</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>March 18, 2021</last_update_submitted>
  <last_update_submitted_qc>March 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Congdon Nathan</investigator_full_name>
    <investigator_title>Professor of Preventative Ophthalmology</investigator_title>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <keyword>follow-up</keyword>
  <keyword>Diabetic retinopathy</keyword>
  <keyword>Diabetic teaching</keyword>
  <keyword>SMS</keyword>
  <keyword>rewards</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03804970
org study id: ZOC-INROADS
nct id: NCT03804970
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Proportion of scheduled eye care visits attended over 1 year
time frame: One year
description: The visits will be recorded during the 1 year
measure: Follow-up HbA1c
time frame: One year
description: This outcome will be recorded in the baseline and end-line examination
measure: Proportion of scheduled endocrine care visits attended over 1 year
time frame: One year
description: The outcome will be recorded during the 1 year
measure: Retinopathy grade in the better seeing eye.
time frame: One year
description: This outcome will be recorded in the baseline and end-line examination
measure: Visual acuity in the better seeing eye.
time frame: One year
description: This outcome will be recorded in the baseline and end-line examination
arm group label: Intervention group
arm group type: Experimental
description: 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
arm group label: Adjusted intervention group
arm group type: Experimental
description: 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)
arm group label: Control group
arm group type: Active Comparator
description: Watching brief video and basic explanation for disease
intervention type: Behavioral
intervention name: cash rewards for the fellow up
description: 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.
arm group label: Adjusted intervention group
arm group label: Intervention group
intervention type: Behavioral
intervention name: Showing retinal photos to participants
description: 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.
arm group label: Adjusted intervention group
arm group label: Intervention group
intervention type: Behavioral
intervention name: SMS reminders for participants and their family
description: 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.
arm group label: Adjusted intervention group
arm group label: Intervention group
intervention type: Behavioral
intervention name: Watching brief video and basic explanation for disease
description: This basic explanation will be offered by professional doctors or nurses.
arm group label: Control group
intervention type: Behavioral
intervention name: Having the Diabetic Club
description: 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.
arm group label: Adjusted intervention group
arm group label: Intervention group
criteria: 
gender: All
minimum age: 50 Years
maximum age: 90 Years
healthy volunteers: No
last name: Nathan Congdon, MD
role: Principal Investigator
affiliation: Zongshan Ophthalmic Center
last name: Wenyong Huang, MD
role: Principal Investigator
affiliation: Zongshan Ophthalmic Center
last name: Chunhui Chen
role: Study Director
affiliation: Yangxi People hospital, Guangdong
last name: Congyao Wang
role: Study Chair
affiliation: Zongshan Ophthalmic Center
facility: 
country: China
citation: 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: 30357401
citation: 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: 30053472
citation: 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: 21639637
citation: 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: 12399340
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Congdon Nathan
investigator title: Professor of Preventative Ophthalmology
sharing ipd: No