<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/NCT02195193</url>
  </required_header>
  <id_info>
    <org_study_id>I-CARE</org_study_id>
    <secondary_id>R01MH100332</secondary_id>
    <nct_id>NCT02195193</nct_id>
  </id_info>
  <brief_title>Integrating Depression Care in Acute Coronary Syndromes Care in China</brief_title>
  <acronym>I-Care</acronym>
  <official_title>Integrating Depression Care in Acute Coronary Syndromes Patients in Low Resource Hospitals in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The George Institute for Global Health, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Peking University Sixth Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The George Institute for Global Health, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall goal of this study is to develop, pilot test, implement, and evaluate a&#xD;
      nurse-coordinated depression care model integrated into the care of Acute Coronary Syndromes&#xD;
      (ACS) patients with rigorous assessment of feasibility, effectiveness, acceptability and cost&#xD;
      in rural China. This study is a large multi-center, randomized clinical trial among 4,000 ACS&#xD;
      patients from 20 rural county hospitals selected from a well-established research network&#xD;
      across China.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">February 2018</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 6 months</measure>
    <time_frame>Before patient discharge and after 6 months from discharge</time_frame>
    <description>Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 6 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in mean PHQ-9 score from baseline to 12 months</measure>
    <time_frame>Before patient discharge and after 12 months from discharge</time_frame>
    <description>Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 12 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Major Adverse Cardiovascular Events (MACE)</measure>
    <time_frame>At least 12 months after discharge</time_frame>
    <description>MACE includes all cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and re-hospitalization due to cardiovascular disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with self-reported adherence to evidence-based Acute Coronary Syndromes (ACS) secondary prevention treatment at 6 and 12 months</measure>
    <time_frame>At 6 and 12 months after discharge</time_frame>
    <description>ACS secondary prevention treatment means combination use of aspirin, clopidogrel, statin, Angiotensin-Converting Enzyme Inhibitors/ Angiotensin Receptor Blocker and/or beta-blocker.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life (EQ5D) at 6 and 12 months after discharge</measure>
    <time_frame>At 6 and 12 months after discharge</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence of Major Adverse Events (MACE) after discharge</measure>
    <time_frame>At 6 month and 12 month after patients discharged from hospital</time_frame>
    <description>Includes all death, non-fatal myocardial infarction, non-fatal stroke, and re-hospitalization for any reasons after discharge</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of patients with improved cardiovascular risk surrogates</measure>
    <time_frame>At 6 month and 12 month after discharge</time_frame>
    <description>Improved cardiovascular risk surrogates include blood pressure &lt; 140/90 mmHg, heart rate &lt; 70 beats/m, serum Low Density Lipoprotein-cholesterol &lt; 100 mg/dL and blood sugar &lt; 7.0 mmol/L</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of patients with increased healthy life style</measure>
    <time_frame>At 6 and 12 months after discharge</time_frame>
    <description>Health life style includes physical activity &gt;= 3 times/wk and more than 30 min. each time; no smoking, no alcohol use, and Body Mass Index (BMI) &lt; 24 Kg/m2</description>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of patients with self-reported adherence to general medicine treatment</measure>
    <time_frame>At 6 and 12 months after discharge</time_frame>
    <description>The Morisky scale has been used to measure patients' self-reported adherence</description>
  </other_outcome>
  <other_outcome>
    <measure>The interactions between the intervention effect on the outcomes and the modifiers</measure>
    <time_frame>At 6 month or 12 month after discharge</time_frame>
    <description>Modifiers include severity of depression measured by Patient Health Questionnaire-9(PHQ-9), events within or without 6 months after discharge, age and gender</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in mean Mini-International Neuropsychiatric Interview (MINI) score, Enriched social support instrument(ESSI) score and Perceived social support score (PSSS) score</measure>
    <time_frame>Before patient discharge and at 6,12 months after discharge</time_frame>
    <description>Subsample study. 800 patients from 4 hospitals.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4043</enrollment>
  <condition>Acute Coronary Syndromes</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Usual Care (UC)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The standard interventions from Clinical Pathway for Acute Coronary Syndromes in China-Phase 3 (CPACS-3) study that are limited to in-patient ACS care (refer to &quot;Usual Care&quot; [UC]), will be implemented in the participating hospitals, and hence will be received by all patients in both intervention (IC) and control (UC) groups; standardized cardiovascular disease education also will be provided to all participants.CPACS-3 registration number is NCT01398228</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Care (IC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Besides of the UC, an nurse-coordinated integrated care model for Acute Coronary Syndromes(ACS) and depression will be delivered to intervention group, including ACS secondary prevention therapies at and after discharge, screening and treatment of depression during hospitalization and after discharge.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Integrated care</intervention_name>
    <description>an integrated care model for ACS and depression delivered by a collaborative team composed of cardiologists/internists and nurses in the same rural county hospital. The collaborative team will be able to provide medical services for the diagnosis and treatment at acute phase of ACS during hospitalization, ACS secondary prevention therapies at and after discharge, and screening and treatment of depression depressive symptom during hospitalization and after discharge. The core of the interventions includes: depressidepressive symptomon screening and classification, individual counseling and medical treatment of depression, group counseling and health education, and follow-up for ACS and depression treatments compliance, IT- system- assisting theassisted management and necessary referral.</description>
    <arm_group_label>Intervention Care (IC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 20 to 79 years old&#xD;
&#xD;
          -  Hospitalized due to a diagnosis of Acute Coronary Syndromes (ACS)&#xD;
&#xD;
          -  ACS is stable (as judged by the treating cardiologist/internist)&#xD;
&#xD;
          -  Signed patient informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Affected by severe cardiovascular disease or medical comorbidity that indicate the&#xD;
             patient's life expectancy is less than 12 months (e.g. class IV heart failure,&#xD;
             terminal cancer)&#xD;
&#xD;
          -  Seriously disabled (unable to travel to the hospital, class IV heart failure at&#xD;
             baseline)&#xD;
&#xD;
          -  Suffering from problems that affect normal communication (e.g., intellectual&#xD;
             impairment, observed mental confusion suggesting dementia, deafness, blindness, etc.)&#xD;
&#xD;
          -  Non-permanent local residents or permanent residents planning to move out within 12&#xD;
             months&#xD;
&#xD;
          -  Pregnant or breast-feeding or planning pregnancy within 12 months&#xD;
&#xD;
          -  Affected by bipolar disorder, schizophrenia or severe depression that meet criteria&#xD;
             for referral including patients with acutely suicidal risk (Beck Depression Inventory&#xD;
             Item9=3)&#xD;
&#xD;
          -  Having alcohol dependence (defined by MINI Alcohol Dependence/Abuse Part)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yangfeng Wu, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Geogre Institute for Global Health, China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The George Institute for Global Health, China</name>
      <address>
        <city>Haidian</city>
        <state>Beijing</state>
        <zip>100088</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>May 17, 2018</last_update_submitted>
  <last_update_submitted_qc>May 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Health Services Research</keyword>
  <keyword>Acute Coronary Syndromes</keyword>
  <keyword>Depression</keyword>
  <keyword>Integrated care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</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/NCT02195193
org study id: I-CARE
secondary id: R01MH100332
nct id: NCT02195193
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The overall goal of this study is to develop, pilot test, implement, and evaluate a
      nurse-coordinated depression care model integrated into the care of Acute Coronary Syndromes
      (ACS) patients with rigorous assessment of feasibility, effectiveness, acceptability and cost
      in rural China. This study is a large multi-center, randomized clinical trial among 4,000 ACS
      patients from 20 rural county hospitals selected from a well-established research network
      across China.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 6 months
time frame: Before patient discharge and after 6 months from discharge
description: Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 6 months
measure: Changes in mean PHQ-9 score from baseline to 12 months
time frame: Before patient discharge and after 12 months from discharge
description: Changes in mean Patient Health Questionnaire-9 (PHQ-9) score from baseline to 12 months
measure: Incidence of Major Adverse Cardiovascular Events (MACE)
time frame: At least 12 months after discharge
description: MACE includes all cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and re-hospitalization due to cardiovascular disease.
measure: Proportion of patients with self-reported adherence to evidence-based Acute Coronary Syndromes (ACS) secondary prevention treatment at 6 and 12 months
time frame: At 6 and 12 months after discharge
description: ACS secondary prevention treatment means combination use of aspirin, clopidogrel, statin, Angiotensin-Converting Enzyme Inhibitors/ Angiotensin Receptor Blocker and/or beta-blocker.
measure: Quality of life (EQ5D) at 6 and 12 months after discharge
time frame: At 6 and 12 months after discharge
measure: Incidence of Major Adverse Events (MACE) after discharge
time frame: At 6 month and 12 month after patients discharged from hospital
description: Includes all death, non-fatal myocardial infarction, non-fatal stroke, and re-hospitalization for any reasons after discharge
measure: Proportion of patients with improved cardiovascular risk surrogates
time frame: At 6 month and 12 month after discharge
description: Improved cardiovascular risk surrogates include blood pressure < 140/90 mmHg, heart rate < 70 beats/m, serum Low Density Lipoprotein-cholesterol < 100 mg/dL and blood sugar < 7.0 mmol/L
measure: Proportion of patients with increased healthy life style
time frame: At 6 and 12 months after discharge
description: Health life style includes physical activity >= 3 times/wk and more than 30 min. each time; no smoking, no alcohol use, and Body Mass Index (BMI) < 24 Kg/m2
measure: Proportion of patients with self-reported adherence to general medicine treatment
time frame: At 6 and 12 months after discharge
description: The Morisky scale has been used to measure patients' self-reported adherence
measure: The interactions between the intervention effect on the outcomes and the modifiers
time frame: At 6 month or 12 month after discharge
description: Modifiers include severity of depression measured by Patient Health Questionnaire-9(PHQ-9), events within or without 6 months after discharge, age and gender
measure: Changes in mean Mini-International Neuropsychiatric Interview (MINI) score, Enriched social support instrument(ESSI) score and Perceived social support score (PSSS) score
time frame: Before patient discharge and at 6,12 months after discharge
description: Subsample study. 800 patients from 4 hospitals.
arm group label: Usual Care (UC)
arm group type: No Intervention
description: The standard interventions from Clinical Pathway for Acute Coronary Syndromes in China-Phase 3 (CPACS-3) study that are limited to in-patient ACS care (refer to "Usual Care" [UC]), will be implemented in the participating hospitals, and hence will be received by all patients in both intervention (IC) and control (UC) groups; standardized cardiovascular disease education also will be provided to all participants.CPACS-3 registration number is NCT01398228
arm group label: Intervention Care (IC)
arm group type: Experimental
description: Besides of the UC, an nurse-coordinated integrated care model for Acute Coronary Syndromes(ACS) and depression will be delivered to intervention group, including ACS secondary prevention therapies at and after discharge, screening and treatment of depression during hospitalization and after discharge.
intervention type: Other
intervention name: Integrated care
description: an integrated care model for ACS and depression delivered by a collaborative team composed of cardiologists/internists and nurses in the same rural county hospital. The collaborative team will be able to provide medical services for the diagnosis and treatment at acute phase of ACS during hospitalization, ACS secondary prevention therapies at and after discharge, and screening and treatment of depression depressive symptom during hospitalization and after discharge. The core of the interventions includes: depressidepressive symptomon screening and classification, individual counseling and medical treatment of depression, group counseling and health education, and follow-up for ACS and depression treatments compliance, IT- system- assisting theassisted management and necessary referral.
arm group label: Intervention Care (IC)
criteria: 
gender: All
minimum age: 20 Years
maximum age: 79 Years
healthy volunteers: No
last name: Yangfeng Wu, MD, PhD
role: Principal Investigator
affiliation: The Geogre Institute for Global Health, China
facility: 
country: China
responsible party type: Sponsor
mesh term: Acute Coronary Syndrome
mesh term: Syndrome
mesh term: Depression
mesh term: Depressive Disorder