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/NCT05996601</url>
    </required_header>
    <id_info>
      <org_study_id>CPINTCLI</org_study_id>
      <nct_id>NCT05996601</nct_id>
    </id_info>
    <brief_title>Evaluation of Improved Outcomes Among Ambulatory Diabetes and/or Hypertensive Patients - an Intervention Study (CPCLINT)</brief_title>
    <acronym>CPCLINT</acronym>
    <official_title>Evaluation of Selected Improved Outcomes Among Patients With Diabetes and/or Hypertension in Designated Community Pharmacies in a Metropolitan City - An Intervention Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Ibadan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Ibadan</source>
    <oversight_info>
      <has_dmc>No</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>
        The goal of this interventional study is to compare improved outcomes among diabetes and/or&#xD;
        hypertensive patients sequel to educational intervention. The study aims to answer the&#xD;
        following questions:&#xD;
  &#xD;
          -  What are the patients' levels of health literacy, medication adherence, disease&#xD;
             knowledge, attitude to disease, physical activity?&#xD;
  &#xD;
          -  Does educational intervention by pharmacists improve health outcomes of patients with&#xD;
             diabetes and/or hypertension?&#xD;
  &#xD;
          -  Are there associations between patient-related variables such as health literacy,&#xD;
             medication adherence, disease knowledge, attitude to disease? Participants'&#xD;
             anthropometric measurements and point-of-care testing for disease monitoring e.g., blood&#xD;
             pressure, blood glucose would be carried out. Baseline assessment of participants would&#xD;
             be done to evaluate their levels of health literacy, medication adherence, disease&#xD;
             knowledge, attitude to disease, physical activity.&#xD;
  &#xD;
        Patients' baseline assessment would be carried out, after which they would receive&#xD;
        educational materials and would be followed up by pharmacist. The baseline assessments would&#xD;
        be repeated at three and six months after the intervention to measure the effectiveness of&#xD;
        the intervention.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The anthropometric measurements would include weight, height, waist circumference, hip&#xD;
        circumference, from which the body mass index and waist-hip ration would be calculated.&#xD;
  &#xD;
        The assessment of the disease knowledge and attitude would be done using validated&#xD;
        semi-structured questionnaires earlier designed by the principal investigator and used among&#xD;
        ambulatory patients with diabetes and/or hypertension accessing care in tertiary healthcare&#xD;
        facilities. The validated International Physical Activity Questionnaire (IPAQ) would be&#xD;
        utilized for participants' physical activity assessment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 28, 2023</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">April 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Blood pressure control</measure>
      <time_frame>6 months</time_frame>
      <description>Participants' blood pressure in mmHg measured at baseline, 3- and 6-month postintervention would be compared to find out if there are changes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Blood glucose control of participants</measure>
      <time_frame>6 months</time_frame>
      <description>Fasting blood glucose in mg/dL measured at baseline, 3- and 6-month postintervention. would be compared.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Participants' level of disease knowledge and attitude</measure>
      <time_frame>6 months</time_frame>
      <description>The knowledge and attitude scale in the semi-structured questionnaire would be evaluated at baseline, 3- and 6-month postintervention.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Participants' body mass index calculated by dividing weight in kilograms by the square of height in meters.</measure>
      <time_frame>6 months</time_frame>
      <description>Participants weight in kilograms and height in meters would be measured at baseline, 3- and 6-month postintervention. Their body mass index would be compared to find out if there are changes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Medication adherence of participants using a 4-item medication adherence scale</measure>
      <time_frame>6 months</time_frame>
      <description>Participants' medication adherence would be evaluated at baseline, 3- and 6-month postintervention using Morisky, Green and Levine 4-item medication adherence scale.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Type 2 Diabetes Mellitus</condition>
    <condition>Hypertension</condition>
    <arm_group>
      <arm_group_label>Intervention arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All participants would undergo educational intervention by pharmacist.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Educational intervention</intervention_name>
      <description>Educational materials would be given to all the participants. They would also be followed up by pharmacist.</description>
      <arm_group_label>Intervention arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Minimum of 18 years of age&#xD;
  &#xD;
            -  Patients must be diagnosed with diabetes and/or hypertension&#xD;
  &#xD;
            -  Patients must be on at least one medication&#xD;
  &#xD;
            -  Patients who access one of the selected community pharmacies for prescription refill&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Non-consented patients&#xD;
  &#xD;
            -  Patients not based at the study site&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Aduke E Ipingbemi, PhD</last_name>
      <role>Study Director</role>
      <affiliation>University of Ibadan, Nigeria.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Akinniyi A Aje / Dr., PhD</last_name>
      <phone>+2348035684484</phone>
      <phone_ext>+234</phone_ext>
      <email>aje123@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Modupe O Aroyewun / Pharm, B. Pharm</last_name>
      <phone>+2348061572544</phone>
      <phone_ext>+234</phone_ext>
      <email>dupsydaniel@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Department of Clinical Pharmacy and Pharmacy Administration, Faculty of Pharmacy, University of Ibadan.</name>
        <address>
          <city>Ibadan</city>
          <state>Oyo</state>
          <zip>200005</zip>
          <country>Nigeria</country>
        </address>
      </facility>
      <contact>
        <last_name>Titilayo O Fakeye / Prof, PhD</last_name>
        <phone>+2348052234484</phone>
        <phone_ext>+234</phone_ext>
        <email>titifakeye@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Nigeria</country>
    </location_countries>
    <reference>
      <citation>Adeloye D, Owolabi EO, Ojji DB, Auta A, Dewan MT, Olanrewaju TO, Ogah OS, Omoyele C, Ezeigwe N, Mpazanje RG, Gadanya MA, Agogo E, Alemu W, Adebiyi AO, Harhay MO. Prevalence, awareness, treatment, and control of hypertension in Nigeria in 1995 and 2020: A systematic analysis of current evidence. J Clin Hypertens (Greenwich). 2021 May;23(5):963-977. doi: 10.1111/jch.14220. Epub 2021 Feb 18.</citation>
      <PMID>33600078</PMID>
    </reference>
    <reference>
      <citation>Uloko AE, Musa BM, Ramalan MA, Gezawa ID, Puepet FH, Uloko AT, Borodo MM, Sada KB. Prevalence and Risk Factors for Diabetes Mellitus in Nigeria: A Systematic Review and Meta-Analysis. Diabetes Ther. 2018 Jun;9(3):1307-1316. doi: 10.1007/s13300-018-0441-1. Epub 2018 May 14.</citation>
      <PMID>29761289</PMID>
    </reference>
    <reference>
      <citation>Milosavljevic A, Aspden T, Harrison J. Community pharmacist-led interventions and their impact on patients' medication adherence and other health outcomes: a systematic review. Int J Pharm Pract. 2018 Oct;26(5):387-397. doi: 10.1111/ijpp.12462. Epub 2018 Jun 21.</citation>
      <PMID>29927005</PMID>
    </reference>
    <reference>
      <citation>Rajiah K, Sivarasa S, Maharajan MK. Impact of Pharmacists' Interventions and Patients' Decision on Health Outcomes in Terms of Medication Adherence and Quality Use of Medicines among Patients Attending Community Pharmacies: A Systematic Review. Int J Environ Res Public Health. 2021 Apr 21;18(9):4392. doi: 10.3390/ijerph18094392.</citation>
      <PMID>33918990</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Ibadan</investigator_affiliation>
      <investigator_full_name>Akinniyi Akinbiyi Aje</investigator_full_name>
      <investigator_title>Experiential Training Coordinator and Sub-Dean Undergraduate (Integrated)</investigator_title>
    </responsible_party>
    <keyword>Diabetes</keyword>
    <keyword>Hypertension</keyword>
    <keyword>Interventional study</keyword>
    <keyword>Health literacy</keyword>
    <keyword>Physical activity</keyword>
    <keyword>Medication adherence</keyword>
    <keyword>Pharmacist</keyword>
    <keyword>Community pharmacy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypertension</mesh_term>
      <mesh_term>Diabetes Mellitus</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>I might not share this based on sensitive nature of data to be collected. However, the group data generated would be shared through publications in peer-reviewed journals for public consumption.</ipd_description>
    </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/NCT05996601
  org study id: CPINTCLI
  nct id: NCT05996601
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this interventional study is to compare improved outcomes among diabetes and/or
        hypertensive patients sequel to educational intervention. The study aims to answer the
        following questions:
  
          -  What are the patients' levels of health literacy, medication adherence, disease
             knowledge, attitude to disease, physical activity?
  
          -  Does educational intervention by pharmacists improve health outcomes of patients with
             diabetes and/or hypertension?
  
          -  Are there associations between patient-related variables such as health literacy,
             medication adherence, disease knowledge, attitude to disease? Participants'
             anthropometric measurements and point-of-care testing for disease monitoring e.g., blood
             pressure, blood glucose would be carried out. Baseline assessment of participants would
             be done to evaluate their levels of health literacy, medication adherence, disease
             knowledge, attitude to disease, physical activity.
  
        Patients' baseline assessment would be carried out, after which they would receive
        educational materials and would be followed up by pharmacist. The baseline assessments would
        be repeated at three and six months after the intervention to measure the effectiveness of
        the intervention.
  The anthropometric measurements would include weight, height, waist circumference, hip
        circumference, from which the body mass index and waist-hip ration would be calculated.
  
        The assessment of the disease knowledge and attitude would be done using validated
        semi-structured questionnaires earlier designed by the principal investigator and used among
        ambulatory patients with diabetes and/or hypertension accessing care in tertiary healthcare
        facilities. The validated International Physical Activity Questionnaire (IPAQ) would be
        utilized for participants' physical activity assessment.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Blood pressure control
  time frame: 6 months
  description: Participants' blood pressure in mmHg measured at baseline, 3- and 6-month postintervention would be compared to find out if there are changes.
  measure: Blood glucose control of participants
  time frame: 6 months
  description: Fasting blood glucose in mg/dL measured at baseline, 3- and 6-month postintervention. would be compared.
  measure: Participants' level of disease knowledge and attitude
  time frame: 6 months
  description: The knowledge and attitude scale in the semi-structured questionnaire would be evaluated at baseline, 3- and 6-month postintervention.
  measure: Participants' body mass index calculated by dividing weight in kilograms by the square of height in meters.
  time frame: 6 months
  description: Participants weight in kilograms and height in meters would be measured at baseline, 3- and 6-month postintervention. Their body mass index would be compared to find out if there are changes.
  measure: Medication adherence of participants using a 4-item medication adherence scale
  time frame: 6 months
  description: Participants' medication adherence would be evaluated at baseline, 3- and 6-month postintervention using Morisky, Green and Levine 4-item medication adherence scale.
  arm group label: Intervention arm
  arm group type: Experimental
  description: All participants would undergo educational intervention by pharmacist.
  intervention type: Behavioral
  intervention name: Educational intervention
  description: Educational materials would be given to all the participants. They would also be followed up by pharmacist.
  arm group label: Intervention arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Aduke E Ipingbemi, PhD
  role: Study Director
  affiliation: University of Ibadan, Nigeria.
  last name: Akinniyi A Aje / Dr., PhD
  phone: +2348035684484
  phone ext: +234
  email: aje123@gmail.com
  last name: Modupe O Aroyewun / Pharm, B. Pharm
  phone: +2348061572544
  phone ext: +234
  email: dupsydaniel@gmail.com
  facility: 
  contact: 
  country: Nigeria
  citation: Adeloye D, Owolabi EO, Ojji DB, Auta A, Dewan MT, Olanrewaju TO, Ogah OS, Omoyele C, Ezeigwe N, Mpazanje RG, Gadanya MA, Agogo E, Alemu W, Adebiyi AO, Harhay MO. Prevalence, awareness, treatment, and control of hypertension in Nigeria in 1995 and 2020: A systematic analysis of current evidence. J Clin Hypertens (Greenwich). 2021 May;23(5):963-977. doi: 10.1111/jch.14220. Epub 2021 Feb 18.
  PMID: 33600078
  citation: Uloko AE, Musa BM, Ramalan MA, Gezawa ID, Puepet FH, Uloko AT, Borodo MM, Sada KB. Prevalence and Risk Factors for Diabetes Mellitus in Nigeria: A Systematic Review and Meta-Analysis. Diabetes Ther. 2018 Jun;9(3):1307-1316. doi: 10.1007/s13300-018-0441-1. Epub 2018 May 14.
  PMID: 29761289
  citation: Milosavljevic A, Aspden T, Harrison J. Community pharmacist-led interventions and their impact on patients' medication adherence and other health outcomes: a systematic review. Int J Pharm Pract. 2018 Oct;26(5):387-397. doi: 10.1111/ijpp.12462. Epub 2018 Jun 21.
  PMID: 29927005
  citation: Rajiah K, Sivarasa S, Maharajan MK. Impact of Pharmacists' Interventions and Patients' Decision on Health Outcomes in Terms of Medication Adherence and Quality Use of Medicines among Patients Attending Community Pharmacies: A Systematic Review. Int J Environ Res Public Health. 2021 Apr 21;18(9):4392. doi: 10.3390/ijerph18094392.
  PMID: 33918990
  responsible party type: Principal Investigator
  investigator affiliation: University of Ibadan
  investigator full name: Akinniyi Akinbiyi Aje
  investigator title: Experiential Training Coordinator and Sub-Dean Undergraduate (Integrated)
  mesh term: Hypertension
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2
  sharing ipd: No
  ipd description: I might not share this based on sensitive nature of data to be collected. However, the group data generated would be shared through publications in peer-reviewed journals for public consumption.