<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/NCT04490941</url>
  </required_header>
  <id_info>
    <org_study_id>SYSU-OPH-007</org_study_id>
    <nct_id>NCT04490941</nct_id>
  </id_info>
  <brief_title>A Trial on Ophthalmologist-delivered Health Education on Top of Routine Community Care</brief_title>
  <official_title>The Effectiveness of Ophthalmologist-delivered Health Education on Top of Routine Community Care in Type 2 Diabetic Patients at Risk for Diabetic Retinopathy: A Parallel-group, Randomised Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhongshan Ophthalmic Center, Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Zhongshan Ophthalmic Center, Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Diabetic retinopathy affects over one third of all people with diabetes and is one of the&#xD;
      leading causes of vision loss. The management of diabetes and its complications should&#xD;
      include screening for diabetic retinopathy. A randomised trial is therefore needed of the use&#xD;
      of a simple and widely practicable approach to explore the integration of eye care in&#xD;
      managing diabetes. The trial is designed as a randomised, controlled, superiority trial. The&#xD;
      aim is to explore the effectiveness of ophthalmologist-delivered health education on top of&#xD;
      routine community care on blood glucose and eye-related clinical outcomes in type 2 diabetic&#xD;
      patients at risk for diabetic retinopathy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diabetic retinopathy (DR) is a highly specific vascular complication of diabetes mellitus,&#xD;
      with prevalence strongly related to a number of risk factors including the duration of&#xD;
      diabetes, the level of glycaemic control, etc. Diabetic retinopathy affects over one third of&#xD;
      all people with diabetes and is one of the leading causes of vision loss. It is recommended&#xD;
      that optimising glycaemic control could reduce the risk or slow the progression of diabetic&#xD;
      retinopathy, and that the management of diabetes and its complications should include&#xD;
      screening for diabetic retinopathy. A randomised trial is therefore needed of the use of a&#xD;
      simple and widely practicable approach to explore the integration of eye care in managing&#xD;
      diabetes. The trial is designed as a randomised, controlled, superiority trial. The aim is to&#xD;
      explore the effectiveness of ophthalmologist-delivered health education on top of routine&#xD;
      community care on blood glucose and eye-related clinical outcomes in type 2 diabetic patients&#xD;
      at risk for diabetic retinopathy. Participants will be randomly assigned to either control or&#xD;
      intervention group with a 1:1 allocation as per computer-generated random numbers. A senior&#xD;
      onsite manager will monitor participant enrolment over the course of the study. An&#xD;
      ophthalmologist-delivered health education will be offered as the intervention in an&#xD;
      individualised, face-to-face counselling session to build awareness on diabetes symptoms,&#xD;
      particularly on diabetic retinopathy, and its risk factors with appropriate management. All&#xD;
      subjects, regardless of the group allocation, will be followed up for 12 months. Baseline and&#xD;
      follow-up profiles will be assessed and collected by clinical personnel blind to group&#xD;
      allocation. The intervention arm will be compared against the control for all primary&#xD;
      analysis. The study was partly supported by the Open Research Funds of the State Key&#xD;
      Laboratory of Ophthalmology. Trial results will be disseminated to key stakeholders and the&#xD;
      general medical community.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 22, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</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>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glycated haemoglobin (HbA1c)</measure>
    <time_frame>12-months follow-up</time_frame>
    <description>Proportion of participants who had optimal control of HbA1c level at 12 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Treatment burden</measure>
    <time_frame>12-months follow-up</time_frame>
    <description>Use of treatment burden questionnaire to quantify item scores for each domain, in detail and together, on treatment burden of patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients' adherence</measure>
    <time_frame>12-months follow-up</time_frame>
    <description>Use of adherence questionnaire to examine the extent to which physician advice, in detail and together, are adhered to by patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass index</measure>
    <time_frame>12-months follow-up</time_frame>
    <description>Use of weight and height to report body mass index in kg/m^2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>12-months follow-up</time_frame>
    <description>Use of systolic and diastolic blood pressure to report blood pressure profile in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cholesterol concentration</measure>
    <time_frame>12-months follow-up</time_frame>
    <description>Use of cholesterol concentration to report lipid profile in mmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>triglyceride concentration</measure>
    <time_frame>12-months follow-up</time_frame>
    <description>Use of triglyceride concentration to report lipid profile in mmol/L</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">652</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ophthalmologist-delivered health education</intervention_name>
    <description>The educational intervention will be conducted on-site by a qualified, experienced ophthalmologist at an ophthalmic center with goals of building awareness on diabetes symptoms, particularly on diabetic retinopathy, and its risk factors with appropriate management.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Usual care follows standard procedure on diabetes management similar to the routine service provision.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 35-80 years&#xD;
&#xD;
          -  Clinically diagnosed with type 2 diabetes&#xD;
&#xD;
          -  At risk of diabetic retinopathy (DR),e.g. no apparent DR or mild non-proliferative DR&#xD;
&#xD;
          -  On regular community care by 'family doctor team' in the context of the National basic&#xD;
             public health service delivery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  With symptoms of cognitive dysfunction, dementia, severe mental disorders, or other&#xD;
             conditions with inability to appropriately convey personal thoughts&#xD;
&#xD;
          -  Type 1 diabetes or gestational diabetes&#xD;
&#xD;
          -  Developed with eye conditions requiring timely treatment, e.g., diabetic macular&#xD;
             edema, severe non-proliferative diabetic retinopathy, or proliferative DR&#xD;
&#xD;
          -  Have a family member (including relatives) who participated in the trial with a&#xD;
             different group assignment&#xD;
&#xD;
          -  Currently enrol in other ongoing interventions that may exert additional effects on&#xD;
             blood glucose control&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yuting LI, MPH</last_name>
    <phone>+86-020-87334687</phone>
    <email>liyuting@gzzoc.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Zhongshan Ophthalmic Center, Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuting LI, MPH</last_name>
      <phone>+86-020-87334687</phone>
      <email>liyuting@gzzoc.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>February 8, 2022</last_update_submitted>
  <last_update_submitted_qc>February 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <!-- 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/NCT04490941
org study id: SYSU-OPH-007
nct id: NCT04490941
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Diabetic retinopathy affects over one third of all people with diabetes and is one of the
      leading causes of vision loss. The management of diabetes and its complications should
      include screening for diabetic retinopathy. A randomised trial is therefore needed of the use
      of a simple and widely practicable approach to explore the integration of eye care in
      managing diabetes. The trial is designed as a randomised, controlled, superiority trial. The
      aim is to explore the effectiveness of ophthalmologist-delivered health education on top of
      routine community care on blood glucose and eye-related clinical outcomes in type 2 diabetic
      patients at risk for diabetic retinopathy.
Diabetic retinopathy (DR) is a highly specific vascular complication of diabetes mellitus,
      with prevalence strongly related to a number of risk factors including the duration of
      diabetes, the level of glycaemic control, etc. Diabetic retinopathy affects over one third of
      all people with diabetes and is one of the leading causes of vision loss. It is recommended
      that optimising glycaemic control could reduce the risk or slow the progression of diabetic
      retinopathy, and that the management of diabetes and its complications should include
      screening for diabetic retinopathy. A randomised trial is therefore needed of the use of a
      simple and widely practicable approach to explore the integration of eye care in managing
      diabetes. The trial is designed as a randomised, controlled, superiority trial. The aim is to
      explore the effectiveness of ophthalmologist-delivered health education on top of routine
      community care on blood glucose and eye-related clinical outcomes in type 2 diabetic patients
      at risk for diabetic retinopathy. Participants will be randomly assigned to either control or
      intervention group with a 1:1 allocation as per computer-generated random numbers. A senior
      onsite manager will monitor participant enrolment over the course of the study. An
      ophthalmologist-delivered health education will be offered as the intervention in an
      individualised, face-to-face counselling session to build awareness on diabetes symptoms,
      particularly on diabetic retinopathy, and its risk factors with appropriate management. All
      subjects, regardless of the group allocation, will be followed up for 12 months. Baseline and
      follow-up profiles will be assessed and collected by clinical personnel blind to group
      allocation. The intervention arm will be compared against the control for all primary
      analysis. The study was partly supported by the Open Research Funds of the State Key
      Laboratory of Ophthalmology. Trial results will be disseminated to key stakeholders and the
      general medical community.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: Glycated haemoglobin (HbA1c)
time frame: 12-months follow-up
description: Proportion of participants who had optimal control of HbA1c level at 12 months
measure: Treatment burden
time frame: 12-months follow-up
description: Use of treatment burden questionnaire to quantify item scores for each domain, in detail and together, on treatment burden of patients
measure: Patients' adherence
time frame: 12-months follow-up
description: Use of adherence questionnaire to examine the extent to which physician advice, in detail and together, are adhered to by patients
measure: Body mass index
time frame: 12-months follow-up
description: Use of weight and height to report body mass index in kg/m^2
measure: Blood pressure
time frame: 12-months follow-up
description: Use of systolic and diastolic blood pressure to report blood pressure profile in mmHg
measure: cholesterol concentration
time frame: 12-months follow-up
description: Use of cholesterol concentration to report lipid profile in mmol/L
measure: triglyceride concentration
time frame: 12-months follow-up
description: Use of triglyceride concentration to report lipid profile in mmol/L
arm group label: Intervention group
arm group type: Experimental
arm group label: Control group
arm group type: Other
intervention type: Other
intervention name: Ophthalmologist-delivered health education
description: The educational intervention will be conducted on-site by a qualified, experienced ophthalmologist at an ophthalmic center with goals of building awareness on diabetes symptoms, particularly on diabetic retinopathy, and its risk factors with appropriate management.
arm group label: Intervention group
intervention type: Other
intervention name: Usual care
description: Usual care follows standard procedure on diabetes management similar to the routine service provision.
arm group label: Control group
criteria: 
gender: All
minimum age: 35 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yuting LI, MPH
phone: +86-020-87334687
email: liyuting@gzzoc.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2