<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/NCT03024307</url>
  </required_header>
  <id_info>
    <org_study_id>OPCSP2016</org_study_id>
    <nct_id>NCT03024307</nct_id>
  </id_info>
  <brief_title>The Effect of OPCSP on Adherence and Clinical Outcomes Among Patients With Rheumatic Diseases</brief_title>
  <official_title>Evaluation of an Outpatient Pharmacy Clinical Services Program on Adherence and Clinical Outcomes Among Patients With Rheumatic Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>RenJi Hospital</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>
      This is a randomised trial on the efficacy of an Outpatient Pharmacy Clinical Services&#xD;
      Program (OPCSP) on adherence and clinical outcomes among patients with rheumatic diseases.The&#xD;
      purpose of this study is to evaluate:&#xD;
&#xD;
        1. rates of medication adherence in the OPCSP program compared with usual care in an&#xD;
           integrated health care system.&#xD;
&#xD;
        2. total direct costs and clinical outcomes in the OPCSP program compared with usual care&#xD;
           in an integrated health care system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomised trial on the efficacy of an Outpatient Pharmacy Clinical Services&#xD;
      Program (OPCSP) on adherence and clinical outcomes among patients with rheumatic&#xD;
      diseases.Three types of rheumatic diseases were included in the study, Systemic lupus&#xD;
      erythematosus (SLE), Ankylosing spondylitis (AS), and Rheumatoid Arthritis(RA). The purpose&#xD;
      of this study is to evaluate:&#xD;
&#xD;
        1. rates of medication adherence in the OPCSP program compared with usual care in an&#xD;
           integrated health care system.&#xD;
&#xD;
        2. total direct costs and clinical outcomes in the OPCSP program compared with usual care&#xD;
           in an integrated health care system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2017</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Medication adherence in the OPCSP program compared with usual care</measure>
    <time_frame>12 months</time_frame>
    <description>Medication adherence would be evaluated by the questionnaire survey, CQR19. Scores of medication adherence would be calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in medical outcomes from baseline at each visit by EQ5D-3L</measure>
    <time_frame>12 months</time_frame>
    <description>The influence of OPCSP on improving medical outcomes would be evaluated by EQ5D-3L. The TTO value would be compared between two arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in direct costs from baseline at each visit</measure>
    <time_frame>12 months</time_frame>
    <description>the influence of OPCSP on reducing direct costs</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">242</enrollment>
  <condition>Rheumatic Diseases</condition>
  <arm_group>
    <arm_group_label>Involvement of pharmacists in improving medication</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pharmacists involved care group. Tools used to improve medication adherence, (1)Patient medication guide (2)tailored Short Messaging Service (SMS) (3)Pharmaceutical follow-up</description>
  </arm_group>
  <arm_group>
    <arm_group_label>usual care only</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients were provided with usual care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>pharmacists involved OPCSP</intervention_name>
    <description>This was an open labelled randomised study. Rheumatic diseases patients were recruited and arbitrarily divided into the intervention group (usual care plus OPCSP) and the non-intervention group (usual care only). Those enrolled in the research were scheduled for follow-up for eight consecutive visits. Improvements in lab results and direct costs were compared longitudinally (pre and post analysis) between the groups.</description>
    <arm_group_label>Involvement of pharmacists in improving medication</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willingness of the subject to participate in the study, proven by signing the informed&#xD;
             consent;&#xD;
&#xD;
          -  Systemic lupus erythematosus (SLE), as defined by meeting at least 4 of 11&#xD;
             classification criteria of American College of Rheumatology for the classification of&#xD;
             systemic lupus erythematosus, either sequentially or coincidentally. The 4 criteria&#xD;
             doesn't need to be present at the time of study enrollment;&#xD;
&#xD;
          -  Patients fulfilled the American College of Rheumatology criteria for RA and AS;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are unwilling to sign the inform consent;&#xD;
&#xD;
          -  Pregnancy or lactation&#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>Shuang Ye, MD</last_name>
    <role>Study Chair</role>
    <affiliation>RenJi Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>South Campus, Ren Ji Hospital</name>
      <address>
        <city>Shanghai</city>
        <zip>201112</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>October 11, 2016</study_first_submitted>
  <study_first_submitted_qc>January 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>March 3, 2021</last_update_submitted>
  <last_update_submitted_qc>March 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>RenJi Hospital</investigator_affiliation>
    <investigator_full_name>Ting Li</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>Pharmaceutical Care</keyword>
  <keyword>Medication Adherence</keyword>
  <keyword>Direct Costs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rheumatic Diseases</mesh_term>
    <mesh_term>Collagen Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03024307
org study id: OPCSP2016
nct id: NCT03024307
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a randomised trial on the efficacy of an Outpatient Pharmacy Clinical Services
      Program (OPCSP) on adherence and clinical outcomes among patients with rheumatic diseases.The
      purpose of this study is to evaluate:

        1. rates of medication adherence in the OPCSP program compared with usual care in an
           integrated health care system.

        2. total direct costs and clinical outcomes in the OPCSP program compared with usual care
           in an integrated health care system.
This is a randomised trial on the efficacy of an Outpatient Pharmacy Clinical Services
      Program (OPCSP) on adherence and clinical outcomes among patients with rheumatic
      diseases.Three types of rheumatic diseases were included in the study, Systemic lupus
      erythematosus (SLE), Ankylosing spondylitis (AS), and Rheumatoid Arthritis(RA). The purpose
      of this study is to evaluate:

        1. rates of medication adherence in the OPCSP program compared with usual care in an
           integrated health care system.

        2. total direct costs and clinical outcomes in the OPCSP program compared with usual care
           in an integrated health care system.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Medication adherence in the OPCSP program compared with usual care
time frame: 12 months
description: Medication adherence would be evaluated by the questionnaire survey, CQR19. Scores of medication adherence would be calculated.
measure: Changes in medical outcomes from baseline at each visit by EQ5D-3L
time frame: 12 months
description: The influence of OPCSP on improving medical outcomes would be evaluated by EQ5D-3L. The TTO value would be compared between two arms
measure: changes in direct costs from baseline at each visit
time frame: 12 months
description: the influence of OPCSP on reducing direct costs
arm group label: Involvement of pharmacists in improving medication
arm group type: Experimental
description: Pharmacists involved care group. Tools used to improve medication adherence, (1)Patient medication guide (2)tailored Short Messaging Service (SMS) (3)Pharmaceutical follow-up
arm group label: usual care only
arm group type: No Intervention
description: Patients were provided with usual care.
intervention type: Other
intervention name: pharmacists involved OPCSP
description: This was an open labelled randomised study. Rheumatic diseases patients were recruited and arbitrarily divided into the intervention group (usual care plus OPCSP) and the non-intervention group (usual care only). Those enrolled in the research were scheduled for follow-up for eight consecutive visits. Improvements in lab results and direct costs were compared longitudinally (pre and post analysis) between the groups.
arm group label: Involvement of pharmacists in improving medication
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Shuang Ye, MD
role: Study Chair
affiliation: RenJi Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: RenJi Hospital
investigator full name: Ting Li
investigator title: Doctor
mesh term: Rheumatic Diseases
mesh term: Collagen Diseases
sharing ipd: Undecided