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/NCT06000813</url>
    </required_header>
    <id_info>
      <org_study_id>2023p001968</org_study_id>
      <secondary_id>1K23DK135798-01</secondary_id>
      <nct_id>NCT06000813</nct_id>
    </id_info>
    <brief_title>REACH-Es: Adapting a Digital Health Tool to Improve Diabetes Medication Adherence Among Latino Adults</brief_title>
    <official_title>REACH-Es: Adapting a Digital Health Tool to Improve Diabetes Medication Adherence Among Latino Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Massachusetts General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Massachusetts General Hospital</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>
        Latino individuals, the fastest growing ethnic minority population in the United States, have&#xD;
        a higher prevalence of type 2 diabetes and diabetes-related complications, and are more&#xD;
        likely to report inconsistent use of diabetes medications than non-Hispanic White&#xD;
        individuals. The proposed project will test an interactive text message-based tool tailored&#xD;
        to address barriers to taking diabetes medications that are relevant to Latino adults. If&#xD;
        found feasible, acceptable, and usable, this intervention could serve as a scalable tool to&#xD;
        improve diabetes management and reduce diabetes-related complications among Latino adults in&#xD;
        the United States.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Latino adults have a disproportionate burden of type 2 diabetes and diabetes-related&#xD;
        complications. Diabetes medication non-adherence is an important modifiable contributor to&#xD;
        suboptimal glycemic management among Latino adults, who are nearly twice as likely to report&#xD;
        non-adherence to diabetes medications as non-Hispanic White individuals. Besides language&#xD;
        barriers, additional commonly reported barriers that contribute to non-adherence in this&#xD;
        population include negative perceptions about insulin use and misunderstanding ongoing need&#xD;
        for diabetes medications once HbA1c has improved. Mobile health (mHealth) technology can&#xD;
        reduce medication adherence barriers and improve adherence behavior, but mHealth tools that&#xD;
        address commonly reported barriers to diabetes medication adherence among Latino adults are&#xD;
        lacking. One such mHealth platform is REACH (Rapid Encouragement/Education And Communications&#xD;
        for Health), a text message-based tool that improved diabetes medication adherence and&#xD;
        glycemic control among English-speaking adults with type 2 diabetes.&#xD;
  &#xD;
        This study will evaluate REACH-Español (hereafter &quot;REACH-Es), an mHealth platform adapted&#xD;
        from the original REACH intervention that will incorporate qualitative input from Latino&#xD;
        adults with type 2 diabetes on barriers to diabetes medication adherence relevant to this&#xD;
        population. Specifically, the investigators will conduct a pilot RCT (n=70) to assess&#xD;
        feasibility, acceptability, and usability of REACH-Es, as well as intervention targets&#xD;
        (diabetes medication adherence and barriers to adherence) comparing REACH-Es to enhanced&#xD;
        treatment as usual; secondary outcomes are HbA1c and diabetes self- efficacy. The project&#xD;
        will generate preliminary data for an R01 hybrid-effectiveness implementation trial of&#xD;
        REACH-Es.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">February 28, 2027</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2026</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility (recruitment rate)</measure>
      <time_frame>Collected at 0 months</time_frame>
      <description>Number of eligible participants who enroll/ Number of eligible participants who are contacted and reached by phone</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility (response rate to 2-way text messages)</measure>
      <time_frame>Collected at 3 and 6 months</time_frame>
      <description>Number of 2-way text messages answered/ Number of 2-way text messages received</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility (retention rate)</measure>
      <time_frame>Collected at 3 and 6 months</time_frame>
      <description>Number of participants enrolled in the study at follow-up/ Number of participants enrolled at the start of the study</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability</measure>
      <time_frame>Collected at 3 and 6 months</time_frame>
      <description>Assessed quantitatively based on utility of REACH-Es on a 0-10 Likert scale and qualitatively through exit interviews.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Usability</measure>
      <time_frame>Collected at 3 and 6 months</time_frame>
      <description>Assessed quantitatively by administering the 10-item Spanish version of the System Usability Scale (SUS) questionnaire, scored on a 0-5 Likert-type scale.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Diabetes Medication adherence</measure>
      <time_frame>Collected at 0, 3, and 6 months</time_frame>
      <description>Assessed using the 11-item Adherence to Refill and Medication Scale (ARMS-d) questionnaire scored on a 0-4 Likert scale (range 12-48).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>IMB barrier sum score</measure>
      <time_frame>Collected at 0, 3, and 6 months</time_frame>
      <description>Calculated by rating each barrier item on a 0-10 scale (1=never to 10=a lot) and identifying each participant's 4 highest- scored barriers (range 4-40).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>HbA1c</measure>
      <time_frame>Collected at 0, 3, and 6 months</time_frame>
      <description>The HbA1c collection will be done through: 1) EHR review if available &lt;3 weeks from the enrollment visit, 2) point-of-care testing; or) clinical lab draw.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diabetes self-efficacy</measure>
      <time_frame>Collected at 0, 3, and 6 months</time_frame>
      <description>Assessed by administering the 8-item Spanish Diabetes Self-Efficacy questionnaire (0-10 Likert scale).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Type 2 Diabetes (Adult Onset)</condition>
    <condition>Medication Adherence</condition>
    <arm_group>
      <arm_group_label>REACH-Es</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in the REACH-Es arm will receive REACH-Es short message service (SMS), as follows: 1) Daily SMS (information related to diet, exercise, self-monitoring of blood glucose, their specific diabetes medication(s), and top 4 medication adherence barriers); 2) Daily two-way SMS (diabetes medication adherence question); 3) Weekly one-way SMS (participants receive weekly feedback on Sunday regarding how many of the last 7 days they took their medicine); 4) A SMS each time an HbA1c is collected with a link to a secure website that displays the result.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Enhanced treatment as usual (ETAU)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will maintain care as usual (medication treatment and physician monitoring) in addition to a welcome SMS following enrollment, a SMS each time an HbA1c is collected with a link to a secure website that displays the result, and bi-monthly information on diabetes self-care education.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>REACH-Es</intervention_name>
      <description>REACH-Español is a mobile health platform adapted from the original REACH intervention to a Latino population with type 2 diabetes. The goal of REACH-Español is to improve diabetes medication adherence and glycemic management in this population.</description>
      <arm_group_label>REACH-Es</arm_group_label>
      <other_name>REACH-Español</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>ETAU</intervention_name>
      <description>Participants will maintain care as usual (medication treatment and physician monitoring) in addition to a welcome SMS following enrollment, a SMS each time an HbA1c is collected with a link to a secure website that displays the result, and bi-monthly information on diabetes self-care education.</description>
      <arm_group_label>Enhanced treatment as usual (ETAU)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Type 2 diabetes mellitus&#xD;
  &#xD;
            -  Have current or prior (since 2018) HbA1c ≥8.0%&#xD;
  &#xD;
            -  Take at least one diabetes medication&#xD;
  &#xD;
            -  Receive care at MGH- affiliated primary care practices (≥2 visits in the past 3 years)&#xD;
  &#xD;
            -  ≥18 yrs&#xD;
  &#xD;
            -  Identify as Latino and/or Hispanic&#xD;
  &#xD;
            -  Speak and read in Spanish as preferred language&#xD;
  &#xD;
            -  Willing and able to provide informed consent&#xD;
  &#xD;
            -  Access to a mobile telephone with text messaging capability&#xD;
  &#xD;
            -  Suboptimal diabetes medication adherence, assessed using the first 2 items in the&#xD;
               Adherence to Refill and Medication Scale (ARMS-d) questionnaire combined: &quot;How&#xD;
               frequently do you forget or decide to not take your diabetes medications?&quot;&#xD;
               Participants who answer sometimes, almost always, and/or always will be considered&#xD;
               eligible for the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Auditory limitations and/or inability to communicate orally&#xD;
  &#xD;
            -  Inability to receive, read, or send a text message (assessed by a trained research&#xD;
               assistant)&#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>Jacqueline Seiglie</last_name>
      <role>Principal Investigator</role>
      <affiliation>Massachusetts General Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jacqueline Seiglie</last_name>
      <phone>714-588-4791</phone>
      <email>jseiglie@mgh.harvard.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Massachusetts General Hospital Diabetes Research Center</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02114</zip>
          <country>United States</country>
        </address>
      </facility>
      <investigator>
        <last_name>Jacqueline Seiglie, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Deborah Wexler, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
      <investigator_full_name>Jacqueline A. Seiglie, MD</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Type 2 diabetes</keyword>
    <keyword>Medication adherence</keyword>
    <keyword>Mobile health</keyword>
    <keyword>Latino adults</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <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>Deidentified IPD can be requested by qualified investigators with interest in type 2 diabetes. Access to the data will be contingent on review and approval of a research proposal and Statistical Analysis Plan.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Data requests can be made 12 months after manuscript publication and will be made available for up to 24 months.</ipd_time_frame>
      <ipd_access_criteria>Access to the data will be contingent on review and approval of a research proposal and Statistical Analysis Plan.</ipd_access_criteria>
    </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/NCT06000813
  org study id: 2023p001968
  secondary id: 1K23DK135798-01
  nct id: NCT06000813
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Latino individuals, the fastest growing ethnic minority population in the United States, have
        a higher prevalence of type 2 diabetes and diabetes-related complications, and are more
        likely to report inconsistent use of diabetes medications than non-Hispanic White
        individuals. The proposed project will test an interactive text message-based tool tailored
        to address barriers to taking diabetes medications that are relevant to Latino adults. If
        found feasible, acceptable, and usable, this intervention could serve as a scalable tool to
        improve diabetes management and reduce diabetes-related complications among Latino adults in
        the United States.
  Latino adults have a disproportionate burden of type 2 diabetes and diabetes-related
        complications. Diabetes medication non-adherence is an important modifiable contributor to
        suboptimal glycemic management among Latino adults, who are nearly twice as likely to report
        non-adherence to diabetes medications as non-Hispanic White individuals. Besides language
        barriers, additional commonly reported barriers that contribute to non-adherence in this
        population include negative perceptions about insulin use and misunderstanding ongoing need
        for diabetes medications once HbA1c has improved. Mobile health (mHealth) technology can
        reduce medication adherence barriers and improve adherence behavior, but mHealth tools that
        address commonly reported barriers to diabetes medication adherence among Latino adults are
        lacking. One such mHealth platform is REACH (Rapid Encouragement/Education And Communications
        for Health), a text message-based tool that improved diabetes medication adherence and
        glycemic control among English-speaking adults with type 2 diabetes.
  
        This study will evaluate REACH-Español (hereafter "REACH-Es), an mHealth platform adapted
        from the original REACH intervention that will incorporate qualitative input from Latino
        adults with type 2 diabetes on barriers to diabetes medication adherence relevant to this
        population. Specifically, the investigators will conduct a pilot RCT (n=70) to assess
        feasibility, acceptability, and usability of REACH-Es, as well as intervention targets
        (diabetes medication adherence and barriers to adherence) comparing REACH-Es to enhanced
        treatment as usual; secondary outcomes are HbA1c and diabetes self- efficacy. The project
        will generate preliminary data for an R01 hybrid-effectiveness implementation trial of
        REACH-Es.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Feasibility (recruitment rate)
  time frame: Collected at 0 months
  description: Number of eligible participants who enroll/ Number of eligible participants who are contacted and reached by phone
  measure: Feasibility (response rate to 2-way text messages)
  time frame: Collected at 3 and 6 months
  description: Number of 2-way text messages answered/ Number of 2-way text messages received
  measure: Feasibility (retention rate)
  time frame: Collected at 3 and 6 months
  description: Number of participants enrolled in the study at follow-up/ Number of participants enrolled at the start of the study
  measure: Acceptability
  time frame: Collected at 3 and 6 months
  description: Assessed quantitatively based on utility of REACH-Es on a 0-10 Likert scale and qualitatively through exit interviews.
  measure: Usability
  time frame: Collected at 3 and 6 months
  description: Assessed quantitatively by administering the 10-item Spanish version of the System Usability Scale (SUS) questionnaire, scored on a 0-5 Likert-type scale.
  measure: Diabetes Medication adherence
  time frame: Collected at 0, 3, and 6 months
  description: Assessed using the 11-item Adherence to Refill and Medication Scale (ARMS-d) questionnaire scored on a 0-4 Likert scale (range 12-48).
  measure: IMB barrier sum score
  time frame: Collected at 0, 3, and 6 months
  description: Calculated by rating each barrier item on a 0-10 scale (1=never to 10=a lot) and identifying each participant's 4 highest- scored barriers (range 4-40).
  measure: HbA1c
  time frame: Collected at 0, 3, and 6 months
  description: The HbA1c collection will be done through: 1) EHR review if available <3 weeks from the enrollment visit, 2) point-of-care testing; or) clinical lab draw.
  measure: Diabetes self-efficacy
  time frame: Collected at 0, 3, and 6 months
  description: Assessed by administering the 8-item Spanish Diabetes Self-Efficacy questionnaire (0-10 Likert scale).
  arm group label: REACH-Es
  arm group type: Experimental
  description: Participants in the REACH-Es arm will receive REACH-Es short message service (SMS), as follows: 1) Daily SMS (information related to diet, exercise, self-monitoring of blood glucose, their specific diabetes medication(s), and top 4 medication adherence barriers); 2) Daily two-way SMS (diabetes medication adherence question); 3) Weekly one-way SMS (participants receive weekly feedback on Sunday regarding how many of the last 7 days they took their medicine); 4) A SMS each time an HbA1c is collected with a link to a secure website that displays the result.
  arm group label: Enhanced treatment as usual (ETAU)
  arm group type: Active Comparator
  description: Participants will maintain care as usual (medication treatment and physician monitoring) in addition to a welcome SMS following enrollment, a SMS each time an HbA1c is collected with a link to a secure website that displays the result, and bi-monthly information on diabetes self-care education.
  intervention type: Behavioral
  intervention name: REACH-Es
  description: REACH-Español is a mobile health platform adapted from the original REACH intervention to a Latino population with type 2 diabetes. The goal of REACH-Español is to improve diabetes medication adherence and glycemic management in this population.
  arm group label: REACH-Es
  other name: REACH-Español
  intervention type: Behavioral
  intervention name: ETAU
  description: Participants will maintain care as usual (medication treatment and physician monitoring) in addition to a welcome SMS following enrollment, a SMS each time an HbA1c is collected with a link to a secure website that displays the result, and bi-monthly information on diabetes self-care education.
  arm group label: Enhanced treatment as usual (ETAU)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jacqueline Seiglie
  role: Principal Investigator
  affiliation: Massachusetts General Hospital
  last name: Jacqueline Seiglie
  phone: 714-588-4791
  email: jseiglie@mgh.harvard.edu
  facility: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Massachusetts General Hospital
  investigator full name: Jacqueline A. Seiglie, MD
  investigator title: Principal Investigator
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2
  sharing ipd: Yes
  ipd description: Deidentified IPD can be requested by qualified investigators with interest in type 2 diabetes. Access to the data will be contingent on review and approval of a research proposal and Statistical Analysis Plan.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: Data requests can be made 12 months after manuscript publication and will be made available for up to 24 months.
  ipd access criteria: Access to the data will be contingent on review and approval of a research proposal and Statistical Analysis Plan.