<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/NCT01690208</url>
  </required_header>
  <id_info>
    <org_study_id>CRE-2012.136-T</org_study_id>
    <nct_id>NCT01690208</nct_id>
  </id_info>
  <brief_title>Evaluation of Morbidities, Endpoints and Reaching Targets in Diabetic Patients Managed by a Diabetes Specialist Team</brief_title>
  <acronym>EMERALD</acronym>
  <official_title>Evaluation of Morbidities, Endpoints and Reaching Targets in Diabetic Patients Managed by an All-encompassing Program Led by a Diabetes Specialist Team</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asia Diabetes Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asia Diabetes Foundation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot translational study aiming to compare the effects of a multi-component care&#xD;
      program with personalized drug regimen augmented by behavioural therapy with psychological&#xD;
      support and peer influence, led by a diabetes specialist team on metabolic control,&#xD;
      psychological health and behaviours in difficult-to-treat type 2 diabetic patients versus&#xD;
      usual care.&#xD;
&#xD;
      The study hypothesis is to evaluate a novel individualized, multicomponent care program to&#xD;
      optimize glycemic control in difficult-to-treat type 2 diabetic patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diabetic patients are at high risk for co-morbidities which are closely related to disease&#xD;
      duration and coexisting cardiovascular risk factors and complications. Data has shown that&#xD;
      the following 3 groups of diabetic patients are at extremely high risk for future events:&#xD;
&#xD;
        1. Obese type 2 diabetic patients: Weight control is a major therapeutic challenge which&#xD;
           often requires cognitive-psychological-behavioral therapy (CBT) in addition to&#xD;
           pharmacological and surgical interventions. After long disease duration, often&#xD;
           characterized by the presence of complications, many obese diabetic patients need&#xD;
           insulin to control glycemia which put them at risk of further weight gain which sets up&#xD;
           a vicious cycle.&#xD;
&#xD;
        2. Young type 2 diabetic patients: In both Pima Indian and Caucasian type 2 diabetic&#xD;
           patients, young age of onset substantially increased risk of cardiovascular and renal&#xD;
           complications, mainly due to long disease duration. Furthermore, these patients often&#xD;
           default follow up or are non-compliant due to competing priorities and lack of symptoms.&#xD;
           These young patients also have marked phenotypic heterogeneity characterised by insulin&#xD;
           insufficiency and/or obesity with strong family history.&#xD;
&#xD;
        3. Diabetic patients with established cardiovascular-renal complications. In a series of&#xD;
           analyses, Chinese type 2 diabetic patients with established cardiovascular and kidney&#xD;
           disease had 38% event rates including all-cause death and cardiovascular-renal&#xD;
           complications including peripheral vascular disease (PVD) over 5 years.&#xD;
&#xD;
      These 3 groups of patients are difficult to treat with many unmet needs requiring complex&#xD;
      treatment regimens, intensive counselling and emotional support.&#xD;
&#xD;
      In a series of studies, the investigators have confirmed the marked benefits of using a team&#xD;
      approach to deliver structured care with particular emphasis on continuation of care and&#xD;
      periodic reminders on clinical outcomes. Preliminary analysis from our peer support program&#xD;
      also demonstrated the benefits of utilizing organized and visual information to communicate&#xD;
      personalized risks and targets, further augmented by peer support, to improve risk factor&#xD;
      control in type 2 diabetic patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2012</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glycemic control as measured by HbA1c compared to baseline</measure>
    <time_frame>36 months</time_frame>
    <description>Outcome measures will be assessed in all 600 patients in the both groups at 1 year and 3 year.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Control of BP compared to baseline.</measure>
    <time_frame>36 months</time_frame>
    <description>Outcome measures will be assessed in all 600 patients in both groups at 1 year and 3 year.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Control of low density lipoprotein (LDL) cholesterol compared to baseline.</measure>
    <time_frame>36 months</time_frame>
    <description>Outcome measures will be assessed in all 600 patients in the both groups at 1 year and 3 year.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Control of BMI and other obesity indices compared to baseline</measure>
    <time_frame>36 months</time_frame>
    <description>Outcome measures will be assessed in all 600 patients in the both groups at 1 year and 3 year.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Diabetes</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>EMERALD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients assigned to the EMERALD group will be invited to join the multi-component program which will last for 1 year. This program will be held on a 4-weekly basis for the first 3-4 months followed by a maintenance program involving 2-4 group activities every year. Between clinic visits, patients in this group will also receive telephone reminders from the staff and peer supporters to reinforce compliance and for social support.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Irrespective of the assignment group, all patients will undergo a baseline comprehensive assessment using the JADE portal disease management system. All patients will also receive a 2-hour session on how to interpret their individualised JADE report and risk profiles, whilst the importance of achieving targets and optimizing self care will be reinforced.&#xD;
Patients assigned to the UC group will be followed up in their usual clinic according to the 'standard' practice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EMERALD</intervention_name>
    <description>Patients assigned to the EMERALD group will be followed up at a Diabetes Centre led by the nurses and supported by diabetologists, with a particular emphasis on individualizing HbA1c goals and selecting drugs based on clinical profiles to maximize benefits and minimize harm.&#xD;
These patients will also undergo an intensive 3 to 4 months empowerment program where patients within the same group, and therefore sharing similar profiles, will return to the centre monthly to undergo a 2-3 hour activity session led by diabetes nurses, peer supporters and paramedics. Between medical visits, the nurses or HCA will telephone the patients at least once to provide support, help problem-shoot and remind them of their follow-up schedule.</description>
    <arm_group_label>EMERALD</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Patients randomised to the usual care group will receive their routine care after the initial baseline comprehensive assessment &amp; explanation of the JADE reports. A repeat comprehensive assessment will then be conducted at year 3.</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Obese type 2 diabetic patients: body mass index (BMI) &gt;27 kg/m2 and/or waist&#xD;
             circumference (WC) &gt;80cm in women and &gt;90cm in men and HbA1c &gt;8% aged 18-70 years&#xD;
&#xD;
          -  Young type 2 diabetic patients: age 35-55 years and HbA1c &gt;8%&#xD;
&#xD;
          -  Diabetic patients with established cardiovascular-renal complications: HbA1c &gt;8% and&#xD;
             known cardiovascular and renal complications with chronic kidney disease (CKD) stage&#xD;
             3-4 (i.e. estimated glomerular filtration rate &lt;60 to &gt;15 ml/min/ per 1.73m2) aged&#xD;
             18-70 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Type 1 diabetes&#xD;
&#xD;
          -  Active malignant disease (Patients with malignant disease who have been disease-free&#xD;
             for at least 5 years are eligible)&#xD;
&#xD;
          -  Life expectancy less than 12 months&#xD;
&#xD;
          -  Any medical illness or condition as judged by the investigators as ineligible to&#xD;
             participate the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juliana Chan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asia Diabetes Foundation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Juliana Chan, MD</last_name>
    <email>jchan@cuhk.edu.hk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rebecca Wong</last_name>
    <email>wongymr@ha.org.hk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>DMEC Centre, Prince of Wales Hospital</name>
      <address>
        <city>Shatin</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rebecca Wong</last_name>
      <email>wongymr@ha.org.hk</email>
    </contact>
    <contact_backup>
      <last_name>Tammy So</last_name>
      <email>tammytyso@yahoo.com.hk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>August 2015</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>August 6, 2015</last_update_submitted>
  <last_update_submitted_qc>August 6, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <keyword>Structure Care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</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/NCT01690208
org study id: CRE-2012.136-T
nct id: NCT01690208
lead sponsor: 
has dmc: Yes
This is a pilot translational study aiming to compare the effects of a multi-component care
      program with personalized drug regimen augmented by behavioural therapy with psychological
      support and peer influence, led by a diabetes specialist team on metabolic control,
      psychological health and behaviours in difficult-to-treat type 2 diabetic patients versus
      usual care.

      The study hypothesis is to evaluate a novel individualized, multicomponent care program to
      optimize glycemic control in difficult-to-treat type 2 diabetic patients.
Diabetic patients are at high risk for co-morbidities which are closely related to disease
      duration and coexisting cardiovascular risk factors and complications. Data has shown that
      the following 3 groups of diabetic patients are at extremely high risk for future events:

        1. Obese type 2 diabetic patients: Weight control is a major therapeutic challenge which
           often requires cognitive-psychological-behavioral therapy (CBT) in addition to
           pharmacological and surgical interventions. After long disease duration, often
           characterized by the presence of complications, many obese diabetic patients need
           insulin to control glycemia which put them at risk of further weight gain which sets up
           a vicious cycle.

        2. Young type 2 diabetic patients: In both Pima Indian and Caucasian type 2 diabetic
           patients, young age of onset substantially increased risk of cardiovascular and renal
           complications, mainly due to long disease duration. Furthermore, these patients often
           default follow up or are non-compliant due to competing priorities and lack of symptoms.
           These young patients also have marked phenotypic heterogeneity characterised by insulin
           insufficiency and/or obesity with strong family history.

        3. Diabetic patients with established cardiovascular-renal complications. In a series of
           analyses, Chinese type 2 diabetic patients with established cardiovascular and kidney
           disease had 38% event rates including all-cause death and cardiovascular-renal
           complications including peripheral vascular disease (PVD) over 5 years.

      These 3 groups of patients are difficult to treat with many unmet needs requiring complex
      treatment regimens, intensive counselling and emotional support.

      In a series of studies, the investigators have confirmed the marked benefits of using a team
      approach to deliver structured care with particular emphasis on continuation of care and
      periodic reminders on clinical outcomes. Preliminary analysis from our peer support program
      also demonstrated the benefits of utilizing organized and visual information to communicate
      personalized risks and targets, further augmented by peer support, to improve risk factor
      control in type 2 diabetic patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Glycemic control as measured by HbA1c compared to baseline
time frame: 36 months
description: Outcome measures will be assessed in all 600 patients in the both groups at 1 year and 3 year.
measure: Control of BP compared to baseline.
time frame: 36 months
description: Outcome measures will be assessed in all 600 patients in both groups at 1 year and 3 year.
measure: Control of low density lipoprotein (LDL) cholesterol compared to baseline.
time frame: 36 months
description: Outcome measures will be assessed in all 600 patients in the both groups at 1 year and 3 year.
measure: Control of BMI and other obesity indices compared to baseline
time frame: 36 months
description: Outcome measures will be assessed in all 600 patients in the both groups at 1 year and 3 year.
arm group label: EMERALD
arm group type: Experimental
description: Patients assigned to the EMERALD group will be invited to join the multi-component program which will last for 1 year. This program will be held on a 4-weekly basis for the first 3-4 months followed by a maintenance program involving 2-4 group activities every year. Between clinic visits, patients in this group will also receive telephone reminders from the staff and peer supporters to reinforce compliance and for social support.
arm group label: Usual Care
arm group type: Active Comparator
description: Irrespective of the assignment group, all patients will undergo a baseline comprehensive assessment using the JADE portal disease management system. All patients will also receive a 2-hour session on how to interpret their individualised JADE report and risk profiles, whilst the importance of achieving targets and optimizing self care will be reinforced.
Patients assigned to the UC group will be followed up in their usual clinic according to the 'standard' practice.
intervention type: Other
intervention name: EMERALD
description: Patients assigned to the EMERALD group will be followed up at a Diabetes Centre led by the nurses and supported by diabetologists, with a particular emphasis on individualizing HbA1c goals and selecting drugs based on clinical profiles to maximize benefits and minimize harm.
These patients will also undergo an intensive 3 to 4 months empowerment program where patients within the same group, and therefore sharing similar profiles, will return to the centre monthly to undergo a 2-3 hour activity session led by diabetes nurses, peer supporters and paramedics. Between medical visits, the nurses or HCA will telephone the patients at least once to provide support, help problem-shoot and remind them of their follow-up schedule.
arm group label: EMERALD
intervention type: Other
intervention name: Usual Care
description: Patients randomised to the usual care group will receive their routine care after the initial baseline comprehensive assessment & explanation of the JADE reports. A repeat comprehensive assessment will then be conducted at year 3.
arm group label: Usual Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Juliana Chan, MD
role: Principal Investigator
affiliation: Asia Diabetes Foundation
last name: Juliana Chan, MD
email: jchan@cuhk.edu.hk
last name: Rebecca Wong
email: wongymr@ha.org.hk
facility: 
status: Recruiting
contact: 
contact backup: 
country: Hong Kong
responsible party type: Sponsor
mesh term: Diabetes Mellitus