xml: <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/NCT06029842</url>
    </required_header>
    <id_info>
      <org_study_id>Clinical pharmacist</org_study_id>
      <nct_id>NCT06029842</nct_id>
    </id_info>
    <brief_title>The Role of a Clinical Pharmacist in the Management of Type 2 Diabetic Patients in a Primary Medical Center in Jordan</brief_title>
    <official_title>A Randomized Controlled Trial to Assess the Role of a Clinical Pharmacist in the Management of Type 2 Diabetic Patients for Optimum Treatment Outcomes in a Primary Medical Center in Jordan</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Jordan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Jordan</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 study aimed to assess the impact of the clinical pharmacist on enhancing type 2 diabetic&#xD;
        patients outcomes in a primary health care center.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        About 103 patients with type 2 diabetes were randomized to control or intervention group, the&#xD;
        control group received a standard care, while the intervention group received the&#xD;
        collaborative care between the clinical pharmacist and physicians. Fasting blood glucose,&#xD;
        HbA1c, Lipid profile, and blood pressure measured for both groups at baseline and after three&#xD;
        months of follow-up. Treatment related problems (TRPs), quality of life, adherence, and&#xD;
        patients knowledge about their medications were assessed. Cost avoidance and clinical&#xD;
        significance of implemented clinical pharmacist interventions were assessed too.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 17, 2022</start_date>
    <completion_date type="Actual">April 24, 2023</completion_date>
    <primary_completion_date type="Actual">April 24, 2023</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>Other</primary_purpose>
      <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>HbA1c</measure>
      <time_frame>3 months</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Lipid profile</measure>
      <time_frame>3 months</time_frame>
      <description>LDL , HDL , TGS</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fasting blood glucose</measure>
      <time_frame>each month for 3 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>blood pressure</measure>
      <time_frame>3 months</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">103</enrollment>
    <condition>Pharmacist-Patient Relations</condition>
    <arm_group>
      <arm_group_label>the intervention group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>this group received the collaborative care between the clinical pharmacist and physicians in a medical center</description>
    </arm_group>
    <arm_group>
      <arm_group_label>the control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>this group received the standard care of physicians in a medical center without clinical pharmacist interventions</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Collaborative approach of clinical pharmacist with physicians in a medical center</intervention_name>
      <description>For those who allocated to the intervention group, the clinical pharmacist interviewed them at each monthly visit about 30 minutes before seeing physicians, the clinical pharmacist identified treatment related problems, provided medication counseling, answered questions asked by patients or physicians, encouraged compliance, offered instructions on self-monitoring of blood pressure and glucose levels, distributed educational materials about diabetes and emphasis was made on optimizing adherence to pharmacological and non- pharmacological therapy. the pharmacist interventions on treatment related problems (TRPs) and proposed patient care plans were discussed with treatng physicians who decided to accept or reject them.</description>
      <arm_group_label>the intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  type 2 diabetic patients who aged 18 years or more with a HbA1c reading 6.5 % or more&#xD;
               at the time of diagnosis&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  pregnant patients&#xD;
  &#xD;
            -  breastfeeding patients&#xD;
  &#xD;
            -  patients with urgent or emergent cases&#xD;
  &#xD;
            -  patients with cognitive impairment&#xD;
  &#xD;
            -  if the patient is unable to provide informed written consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Abu-Nsair medical center</name>
        <address>
          <city>Amman</city>
          <country>Jordan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Jordan</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Jordan</investigator_affiliation>
      <investigator_full_name>Jyana Alelaimat</investigator_full_name>
      <investigator_title>Master student at the University of Jordan</investigator_title>
    </responsible_party>
    <keyword>clinical pharmacist</keyword>
    <keyword>medical center</keyword>
    <keyword>Ministry of Health</keyword>
    <keyword>Collaborative approach</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06029842
  org study id: Clinical pharmacist
  nct id: NCT06029842
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study aimed to assess the impact of the clinical pharmacist on enhancing type 2 diabetic
        patients outcomes in a primary health care center.
  About 103 patients with type 2 diabetes were randomized to control or intervention group, the
        control group received a standard care, while the intervention group received the
        collaborative care between the clinical pharmacist and physicians. Fasting blood glucose,
        HbA1c, Lipid profile, and blood pressure measured for both groups at baseline and after three
        months of follow-up. Treatment related problems (TRPs), quality of life, adherence, and
        patients knowledge about their medications were assessed. Cost avoidance and clinical
        significance of implemented clinical pharmacist interventions were assessed too.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  measure: HbA1c
  time frame: 3 months
  measure: Lipid profile
  time frame: 3 months
  description: LDL , HDL , TGS
  measure: Fasting blood glucose
  time frame: each month for 3 months
  measure: blood pressure
  time frame: 3 months
  arm group label: the intervention group
  arm group type: Other
  description: this group received the collaborative care between the clinical pharmacist and physicians in a medical center
  arm group label: the control group
  arm group type: No Intervention
  description: this group received the standard care of physicians in a medical center without clinical pharmacist interventions
  intervention type: Other
  intervention name: Collaborative approach of clinical pharmacist with physicians in a medical center
  description: For those who allocated to the intervention group, the clinical pharmacist interviewed them at each monthly visit about 30 minutes before seeing physicians, the clinical pharmacist identified treatment related problems, provided medication counseling, answered questions asked by patients or physicians, encouraged compliance, offered instructions on self-monitoring of blood pressure and glucose levels, distributed educational materials about diabetes and emphasis was made on optimizing adherence to pharmacological and non- pharmacological therapy. the pharmacist interventions on treatment related problems (TRPs) and proposed patient care plans were discussed with treatng physicians who decided to accept or reject them.
  arm group label: the intervention group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Jordan
  responsible party type: Principal Investigator
  investigator affiliation: University of Jordan
  investigator full name: Jyana Alelaimat
  investigator title: Master student at the University of Jordan
  sharing ipd: Yes