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/NCT05979142</url>
    </required_header>
    <id_info>
      <org_study_id>1912252903</org_study_id>
      <nct_id>NCT05979142</nct_id>
    </id_info>
    <brief_title>Community-based Primary Care Program Effects on Pharmacotherapy of Type 2 Diabetes and Hypertension in Peru</brief_title>
    <official_title>A Prospective Cohort Study of a Community-based Primary Care Program's Effects on Pharmacotherapy Quality in Low-income Peruvians With Type 2 Diabetes and Hypertension</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Asociación Siempre Salud</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Arizona</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Asociación Siempre Salud</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 observational study is to compare usual care to a community-based primary&#xD;
        care program (having components of treatment decisions based on clinical guidelines,&#xD;
        self-management education, community health workers, and free health care visits and&#xD;
        medications) in low-income Peruvians with type 2 diabetes and/or hypertension.&#xD;
  &#xD;
        The main question[s] it aims to answer are:&#xD;
  &#xD;
          -  Compared to pre-program usual care, does the program result in greater benefits,&#xD;
             measured as greater proportions of patients with glucose and blood pressure control or&#xD;
             maximal quantities and doses of medications?&#xD;
  &#xD;
          -  Are there greater benefits when the program was provided at home compared to when the&#xD;
             program was provided in a clinic?&#xD;
  &#xD;
          -  Does longer participation in the program result in greater benefits?&#xD;
  &#xD;
        Participants will participate in:&#xD;
  &#xD;
          -  Self-management education provided by community health workers.&#xD;
  &#xD;
          -  Monitoring of healthy behaviors and glucose, blood pressure, and weight.&#xD;
  &#xD;
          -  Receipt of free medications for blood pressure, glucose, and heart disease prevention.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A pre-post study of visit-level data gathered prospectively during a community-based primary&#xD;
        care program evaluated its effects on pharmacotherapy of type 2 diabetes and hypertension.&#xD;
        The program was conducted by Asociación Siempre Salud, a Peruvian non-profit organization, in&#xD;
        three neighborhoods (&quot;the community&quot;) in Pueblo Nuevo, Chincha District, Peru. Door-to-door&#xD;
        surveys identified all persons residing in the study community. Persons &gt; 35 years old were&#xD;
        eligible, without exclusions, to participate in type 2 diabetes and hypertension screening&#xD;
        and diagnosis. Most participated in mass screenings between September and December 2011,&#xD;
        others in later ad hoc screenings. Patients with negative screening results on medications&#xD;
        were re-screened following medication withdrawal. Those with confirmed diagnoses were&#xD;
        eligible to participate in the program.&#xD;
  &#xD;
        Three binary exposures were evaluated for their effects on adherence to four treatment&#xD;
        standards and one composite standard: 1) 'program exposure' (post- vs. pre-exposure); 2)&#xD;
        'program retention in care' (&gt;50% of allowable time in both home and clinic care periods,&#xD;
        compared to &lt;50% in either care period (but not both)), and 3) 'care period', (clinic&#xD;
        compared to home care). 'Care period treatment time' (&gt;50% of allowable time versus less) was&#xD;
        evaluated as an independent variable in the study of the care period exposure.&#xD;
  &#xD;
        During the pre-exposure period, usual care was provided by two public hospitals, several&#xD;
        Ministry of Health clinics, private clinics and pharmacies, and Siempre Salud. The program,&#xD;
        to which patients were then exposed, had components of four CCM elements (delivery system&#xD;
        design, self-management, decision support, and community resources), CHWs, and no&#xD;
        out-of-pocket costs for visits and medications. Self-management was based on national&#xD;
        standards and utilized educational materials from professional societies and government&#xD;
        agencies in the USA. Decision support consisted of guidelines-based standards adapted to our&#xD;
        low-resource setting and simplified medication treatment protocols for diabetes,&#xD;
        hypertension, and primary prevention of CVD. The delivery system consisted of two care models&#xD;
        employed sequentially: first home care, then clinic care (see care period exposure).&#xD;
  &#xD;
        During the home care period, the physician made an initial visit, after which CHWs made&#xD;
        weekly visits to patients' homes. CHWs monitored clinical parameters, provided&#xD;
        self-management education and support, tracked self-care behaviors, documented visits, acted&#xD;
        on clinical alerts, and delivered medications. They entered encounter data into a spreadsheet&#xD;
        and filled prescriptions under physician supervision. The physician made treatment decisions&#xD;
        reliant on home visit data and patient care conferences. During the subsequent clinic period,&#xD;
        patients made monthly visits to the clinic physician who provided all care.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 2011</start_date>
    <completion_date type="Actual">May 2014</completion_date>
    <primary_completion_date type="Actual">May 2014</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Hypoglycemic agent standard</measure>
      <time_frame>27 months</time_frame>
      <description>Standard was defined as glycemic control or maximum doses of two hypoglycemic agents (metformin and glibenclamide) in eligible patients with type 2 diabetes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Antihypertensive agent standard</measure>
      <time_frame>27 months</time_frame>
      <description>Standard was defined blood pressure control or maximum doses of three or more antihypertensive agents in eligible patients with elevated blood pressure (&gt;130/80 mm Hg in diabetics, &gt;140/90 mm Hg in non-diabetics)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Angiotensin-converting enzyme inhibitor (ACEi) standard</measure>
      <time_frame>27 months</time_frame>
      <description>Standard was defined as any ACEi in eligible patients with diabetes and elevated BP (&gt;130/80 mm Hg).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Low-dose aspirin standard</measure>
      <time_frame>27 months</time_frame>
      <description>Standard was defined as any low-dose aspirin in eligible patients with 10-year cardiovascular disease (CVD) risk &gt;10%.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Composite standard</measure>
      <time_frame>27 months</time_frame>
      <description>Coded 'yes' if all treatment standards for which eligible were achieved.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">131</enrollment>
    <condition>Type 2 Diabetes</condition>
    <condition>Hypertension</condition>
    <arm_group>
      <arm_group_label>program (pre-exposure)</arm_group_label>
      <description>During the pre-exposure period, usual care was provided by two public hospitals, several Ministry of Health clinics, private clinics and pharmacies, and Siempre Salud.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>program (post-exposure)</arm_group_label>
      <description>The program had components of four Chronic Care Model (CCM) elements (delivery system design, self-management, decision support, and community resources), community health workers (CHWs), and no out-of-pocket costs for visits and medications.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>community-based primary care program</intervention_name>
      <description>See group description</description>
      <arm_group_label>program (post-exposure)</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Three neighborhoods (&quot;the community&quot;) in Pueblo Nuevo, Chincha District, Ica, Peru&#xD;
          participated in the study. Peru is a middle-income country, but most people in the study&#xD;
          community live below the poverty line. Door-to-door surveys identified all persons residing&#xD;
          in the study community. Patients 35 years and older were eligible to participate in&#xD;
          diabetes and hypertension screening. 83% of all eligible persons participated in mass&#xD;
          screenings between September and December 2011. Others participated in later ad hoc&#xD;
          screenings. Those with confirmed diagnoses of type 2 diabetes and/or hypertension were&#xD;
          eligible to participate in the program.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          35 years or older with confirmed diagnosis of type 2 diabetes and/or hypertension&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          None&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>35 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>John E Deaver, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Asociación Siempre Salud</affiliation>
    </overall_official>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 30, 2023</last_update_submitted>
    <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>low and middle income countries</keyword>
    <keyword>primary care</keyword>
    <keyword>chronic care model</keyword>
    <keyword>community health workers</keyword>
    <keyword>cohort study</keyword>
    <keyword>pharmacotherapy</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>Yes</sharing_ipd>
      <ipd_description>De-identified study data in the following formats: Stata (*.dta) and comma-delimited text (*.csv) files and a data dictionary will be shared with Dryad data repository.</ipd_description>
      <ipd_time_frame>during submission of manuscript for publication</ipd_time_frame>
    </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/NCT05979142
  org study id: 1912252903
  nct id: NCT05979142
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to compare usual care to a community-based primary
        care program (having components of treatment decisions based on clinical guidelines,
        self-management education, community health workers, and free health care visits and
        medications) in low-income Peruvians with type 2 diabetes and/or hypertension.
  
        The main question[s] it aims to answer are:
  
          -  Compared to pre-program usual care, does the program result in greater benefits,
             measured as greater proportions of patients with glucose and blood pressure control or
             maximal quantities and doses of medications?
  
          -  Are there greater benefits when the program was provided at home compared to when the
             program was provided in a clinic?
  
          -  Does longer participation in the program result in greater benefits?
  
        Participants will participate in:
  
          -  Self-management education provided by community health workers.
  
          -  Monitoring of healthy behaviors and glucose, blood pressure, and weight.
  
          -  Receipt of free medications for blood pressure, glucose, and heart disease prevention.
  A pre-post study of visit-level data gathered prospectively during a community-based primary
        care program evaluated its effects on pharmacotherapy of type 2 diabetes and hypertension.
        The program was conducted by Asociación Siempre Salud, a Peruvian non-profit organization, in
        three neighborhoods ("the community") in Pueblo Nuevo, Chincha District, Peru. Door-to-door
        surveys identified all persons residing in the study community. Persons > 35 years old were
        eligible, without exclusions, to participate in type 2 diabetes and hypertension screening
        and diagnosis. Most participated in mass screenings between September and December 2011,
        others in later ad hoc screenings. Patients with negative screening results on medications
        were re-screened following medication withdrawal. Those with confirmed diagnoses were
        eligible to participate in the program.
  
        Three binary exposures were evaluated for their effects on adherence to four treatment
        standards and one composite standard: 1) 'program exposure' (post- vs. pre-exposure); 2)
        'program retention in care' (>50% of allowable time in both home and clinic care periods,
        compared to <50% in either care period (but not both)), and 3) 'care period', (clinic
        compared to home care). 'Care period treatment time' (>50% of allowable time versus less) was
        evaluated as an independent variable in the study of the care period exposure.
  
        During the pre-exposure period, usual care was provided by two public hospitals, several
        Ministry of Health clinics, private clinics and pharmacies, and Siempre Salud. The program,
        to which patients were then exposed, had components of four CCM elements (delivery system
        design, self-management, decision support, and community resources), CHWs, and no
        out-of-pocket costs for visits and medications. Self-management was based on national
        standards and utilized educational materials from professional societies and government
        agencies in the USA. Decision support consisted of guidelines-based standards adapted to our
        low-resource setting and simplified medication treatment protocols for diabetes,
        hypertension, and primary prevention of CVD. The delivery system consisted of two care models
        employed sequentially: first home care, then clinic care (see care period exposure).
  
        During the home care period, the physician made an initial visit, after which CHWs made
        weekly visits to patients' homes. CHWs monitored clinical parameters, provided
        self-management education and support, tracked self-care behaviors, documented visits, acted
        on clinical alerts, and delivered medications. They entered encounter data into a spreadsheet
        and filled prescriptions under physician supervision. The physician made treatment decisions
        reliant on home visit data and patient care conferences. During the subsequent clinic period,
        patients made monthly visits to the clinic physician who provided all care.
  observational model: Cohort
  time perspective: Prospective
  measure: Hypoglycemic agent standard
  time frame: 27 months
  description: Standard was defined as glycemic control or maximum doses of two hypoglycemic agents (metformin and glibenclamide) in eligible patients with type 2 diabetes.
  measure: Antihypertensive agent standard
  time frame: 27 months
  description: Standard was defined blood pressure control or maximum doses of three or more antihypertensive agents in eligible patients with elevated blood pressure (>130/80 mm Hg in diabetics, >140/90 mm Hg in non-diabetics)
  measure: Angiotensin-converting enzyme inhibitor (ACEi) standard
  time frame: 27 months
  description: Standard was defined as any ACEi in eligible patients with diabetes and elevated BP (>130/80 mm Hg).
  measure: Low-dose aspirin standard
  time frame: 27 months
  description: Standard was defined as any low-dose aspirin in eligible patients with 10-year cardiovascular disease (CVD) risk >10%.
  measure: Composite standard
  time frame: 27 months
  description: Coded 'yes' if all treatment standards for which eligible were achieved.
  arm group label: program (pre-exposure)
  description: During the pre-exposure period, usual care was provided by two public hospitals, several Ministry of Health clinics, private clinics and pharmacies, and Siempre Salud.
  arm group label: program (post-exposure)
  description: The program had components of four Chronic Care Model (CCM) elements (delivery system design, self-management, decision support, and community resources), community health workers (CHWs), and no out-of-pocket costs for visits and medications.
  intervention type: Other
  intervention name: community-based primary care program
  description: See group description
  arm group label: program (post-exposure)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 35 Years
  maximum age: N/A
  healthy volunteers: No
  last name: John E Deaver, MD
  role: Principal Investigator
  affiliation: Asociación Siempre Salud
  responsible party type: Sponsor
  mesh term: Hypertension
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2
  sharing ipd: Yes
  ipd description: De-identified study data in the following formats: Stata (*.dta) and comma-delimited text (*.csv) files and a data dictionary will be shared with Dryad data repository.
  ipd time frame: during submission of manuscript for publication