<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/NCT02990299</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0380</org_study_id>
    <secondary_id>1R01DK108141</secondary_id>
    <nct_id>NCT02990299</nct_id>
  </id_info>
  <brief_title>mHealth for Diabetes Adherence Support</brief_title>
  <acronym>mDAS</acronym>
  <official_title>mHealth for Diabetes Adherence Support</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Illinois at Chicago</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>University of Illinois at Chicago</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>
      The purpose of this research study is to determine the benefit and cost of including health&#xD;
      coaches, clinical pharmacists and mobile health (mHealth) tools such as text messaging and&#xD;
      videoconferencing in diabetes management support services for African-Americans and Latinos&#xD;
      with uncontrolled Type 2 Diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many African-Americans and Latinos with diabetes do not achieve recommended diabetes goals&#xD;
      placing them at high risk for complications. Team-based models of care can help in reaching&#xD;
      goals of therapy. Additionally, mobile health (mHealth) technologies can further improve&#xD;
      outcomes among those more difficult to reach. This study will evaluate the impact of a&#xD;
      team-based, mHealth intervention designed to improve medication adherence, healthy eating,&#xD;
      and physical activity behaviors. The investigators will compare this mHealth approach with&#xD;
      usual care.&#xD;
&#xD;
      Clinical pharmacists and health coaches (HC) will deliver our proposed team-based&#xD;
      intervention. mHealth delivery includes mobile phone text messaging, secure&#xD;
      videoconferencing, and HC home visits. Pharmacists will focus on medication reconciliation&#xD;
      and adherence. Health coaches will help identify psychosocial and environmental challenges to&#xD;
      adherence in a culturally-sensitive manner. Together, they can assist in goal-setting,&#xD;
      problem-solving, negotiation of competing priorities, and provide social support leveraging&#xD;
      mHealth technologies.&#xD;
&#xD;
      Preliminary data from previous research by the research team supports the role of health&#xD;
      coaches partnering with clinic- based pharmacists in improving diabetes outcomes in&#xD;
      minorities. In the proposed mHealth intervention, patient- pharmacist videoconferencing will&#xD;
      eliminate the need for in-person visits with a pharmacist, which is impractical for many&#xD;
      low-income patients. In addition, pilot work suggests that text messaging is a preferable&#xD;
      means of communication and may facilitate more frequent contact with patients.&#xD;
&#xD;
      This is a randomized, controlled trial to evaluate the effectiveness of an mHealth diabetes&#xD;
      adherence support intervention delivered by clinical pharmacists and health coaches. The&#xD;
      research team will randomize 220 patients through UI Health to either: (1) mHealth diabetes&#xD;
      adherence support through clinical pharmacists and health coaches; or (2) usual care. After&#xD;
      one year, patients completing the mHealth intervention will be monitored for an additional&#xD;
      year while the usual care group receives the mHealth approach. Outcomes include medication&#xD;
      adherence, hemoglobin A1c, blood pressure, and LDL-cholesterol levels. The specific aims&#xD;
      include: (1) evaluate the effectiveness of an mHealth diabetes adherence support intervention&#xD;
      delivered by clinical pharmacists and health coaches to African-American and Latino adults&#xD;
      with uncontrolled type 2 diabetes; (2) evaluate the maintenance of improved diabetes&#xD;
      behaviors as well as clinical outcomes one year after completing the intervention; (3)&#xD;
      evaluate the cost and cost-effectiveness of mHealth diabetes adherence support compared to&#xD;
      usual care; and (4) evaluate the reach, adoption, and implementation of mHealth diabetes&#xD;
      adherence support based on the RE-AIM framework.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 24, 2017</start_date>
  <completion_date type="Actual">January 7, 2022</completion_date>
  <primary_completion_date type="Actual">January 7, 2022</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>
    <intervention_model_description>A 2-arm, parallel, randomized controlled trial. Patients are randomized 1:1 to (1) mHealth diabetes adherence support intervention for one year and monitored with usual care for the second year, or (2) wait-list usual care for one year, then intervention during the second year.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hemoglobin A1c</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-reported medication adherence</measure>
    <time_frame>24 months</time_frame>
    <description>A 3-item questionnaire will be administered to measure adherence to diabetes medications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood Pressure</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL Cholesterol</measure>
    <time_frame>24 months</time_frame>
    <description>LDL Cholesterol will be measured as part of a Full Lipid profile blood test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes Self-Management</measure>
    <time_frame>24 months</time_frame>
    <description>Self-management will be measured by the revised 11-item Summary of Diabetes Self Care Activities questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life</measure>
    <time_frame>24 months</time_frame>
    <description>General health-related quality of life will be measured by the EuroQOL 5D (EQ-5D).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes related quality of life</measure>
    <time_frame>24 months</time_frame>
    <description>Diabetes-related quality of life will be measured by the Diabetes Distress Screening Instrument (DDS4).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>24 months</time_frame>
    <description>Measured with the nine-item Patient Health Questionnaire (PHQ-9)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol Misuse</measure>
    <time_frame>24 months</time_frame>
    <description>Measured using the 3-item AUDIT-C questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI</measure>
    <time_frame>24 months</time_frame>
    <description>Height and weight will be taken at each time point to determine BMI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Support</measure>
    <time_frame>24 months</time_frame>
    <description>4-item questionnaire measuring satisfaction with support from friends, family and health care team</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes Self-efficacy</measure>
    <time_frame>24 months</time_frame>
    <description>8 -item questionnaire measuring confidence in diabetes self-management skills</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Healthcare utilization</measure>
    <time_frame>24 months</time_frame>
    <description>This will include costs associated with hospital admissions, emergency room and outpatient visits and prescription medications.</description>
  </other_outcome>
  <other_outcome>
    <measure>Program cost</measure>
    <time_frame>24 months</time_frame>
    <description>This will include costs associated with the intervention including pharmacists and health coaches (training, salaries, implementation), educational materials, tablet computers and associated data service, text messaging and videoconferencing.</description>
  </other_outcome>
  <other_outcome>
    <measure>Health Coach Satisfaction</measure>
    <time_frame>1 year after health coach assignment</time_frame>
    <description>A survey administered to the patient for feedback on their assigned health coach.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">221</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will receive their usual care for the first year of their enrollment in the study. They will receive a referral to a diabetes educator and a clinical pharmacist, a one-page sheet of contact information for their healthcare providers, and paper-based, low-literacy diabetes information. After one year, they will change to the mDAS intervention arm for one year.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mHealth for Diabetes Adherence Support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive in-person support from a health coach and a clinical pharmacist with whom they will meet with regularly via videoconference. After one year, participants who have completed the mDAS intervention will be monitored for an additional year with usual care to evaluate maintenance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>mHealth for Diabetes Adherence Support</intervention_name>
    <description>Participants will be paired with a health coach who will provide ongoing support and resources in medication and lifestyle adherence and diabetes self-management. The health coach will perform regular home visits, telephone support and tailored text-messages based on the participant's preferences and needs. They will help assess barriers to adherence and use motivational interviewing to help patients set goals and create action plans. They will also facilitate videoconferences with an assigned clinical pharmacist who will provide consultation on medication use, reconciliation and adherence, identify therapeutic goals and formulate an approved plan of care.</description>
    <arm_group_label>mHealth for Diabetes Adherence Support</arm_group_label>
    <other_name>mDAS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Self-identified as Latino/Hispanic or African-American&#xD;
&#xD;
          -  Verbal fluency in English or Spanish&#xD;
&#xD;
          -  Latest A1c ≥ 8.0% (within 3 mo)&#xD;
&#xD;
          -  History of Type 2 Diabetes (&gt; 1 year)&#xD;
&#xD;
          -  Between the ages of 21 and 75 years&#xD;
&#xD;
          -  Unlimited mobile phone/text messaging plan with ability to reply to text messages&#xD;
&#xD;
          -  Home environment capable of video conferencing with wireless signal&#xD;
&#xD;
          -  Receives primary care at UI Health clinical site for at least one year, with one visit&#xD;
             during past year&#xD;
&#xD;
          -  Able and willing to provide informed consent (agree to data collection requirements,&#xD;
             accept randomization, agree to home visitation with HC and pharmacist involvement, and&#xD;
             participate for two years)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to verbalize comprehension of study or impaired decision making&#xD;
&#xD;
          -  Family/household member already participating in same study&#xD;
&#xD;
          -  Currently receiving regular pharmacist support through Medication Therapy Management&#xD;
             or equivalent&#xD;
&#xD;
          -  History of, or planned, gastric bypass or transplant surgery&#xD;
&#xD;
          -  History of bipolar or psychotic disorder&#xD;
&#xD;
          -  Other severe comorbidities that require complex, aggressive, or palliative treatment,&#xD;
             e.g., stage 4 or greater renal disease, liver failure, cancer (other than nonmelanoma&#xD;
             skin cancer), terminal illness&#xD;
&#xD;
          -  Investigator discretion for safety concerns&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ben S Gerber, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Illinois at Chicago</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lisa K Sharp, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Illinois at Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Illinois Hospital and Health Sciences System</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Sharp LK, Biggers A, Perez R, Henkins J, Tilton J, Gerber BS. A Pharmacist and Health Coach-Delivered Mobile Health Intervention for Type 2 Diabetes: Protocol for a Randomized Controlled Crossover Study. JMIR Res Protoc. 2021 Mar 10;10(3):e17170. doi: 10.2196/17170.</citation>
    <PMID>33688847</PMID>
  </results_reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>June 9, 2023</last_update_submitted>
  <last_update_submitted_qc>June 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Illinois at Chicago</investigator_affiliation>
    <investigator_full_name>Ben Gerber</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Diabetes Mellitus, Type 2</keyword>
  <keyword>Medication Adherence</keyword>
  <keyword>Telemedicine</keyword>
  <keyword>Community Health Workers</keyword>
  <keyword>Pharmacists</keyword>
  <keyword>Mobile Health</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>No</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/NCT02990299
org study id: 2016-0380
secondary id: 1R01DK108141
nct id: NCT02990299
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is to determine the benefit and cost of including health
      coaches, clinical pharmacists and mobile health (mHealth) tools such as text messaging and
      videoconferencing in diabetes management support services for African-Americans and Latinos
      with uncontrolled Type 2 Diabetes.
Many African-Americans and Latinos with diabetes do not achieve recommended diabetes goals
      placing them at high risk for complications. Team-based models of care can help in reaching
      goals of therapy. Additionally, mobile health (mHealth) technologies can further improve
      outcomes among those more difficult to reach. This study will evaluate the impact of a
      team-based, mHealth intervention designed to improve medication adherence, healthy eating,
      and physical activity behaviors. The investigators will compare this mHealth approach with
      usual care.

      Clinical pharmacists and health coaches (HC) will deliver our proposed team-based
      intervention. mHealth delivery includes mobile phone text messaging, secure
      videoconferencing, and HC home visits. Pharmacists will focus on medication reconciliation
      and adherence. Health coaches will help identify psychosocial and environmental challenges to
      adherence in a culturally-sensitive manner. Together, they can assist in goal-setting,
      problem-solving, negotiation of competing priorities, and provide social support leveraging
      mHealth technologies.

      Preliminary data from previous research by the research team supports the role of health
      coaches partnering with clinic- based pharmacists in improving diabetes outcomes in
      minorities. In the proposed mHealth intervention, patient- pharmacist videoconferencing will
      eliminate the need for in-person visits with a pharmacist, which is impractical for many
      low-income patients. In addition, pilot work suggests that text messaging is a preferable
      means of communication and may facilitate more frequent contact with patients.

      This is a randomized, controlled trial to evaluate the effectiveness of an mHealth diabetes
      adherence support intervention delivered by clinical pharmacists and health coaches. The
      research team will randomize 220 patients through UI Health to either: (1) mHealth diabetes
      adherence support through clinical pharmacists and health coaches; or (2) usual care. After
      one year, patients completing the mHealth intervention will be monitored for an additional
      year while the usual care group receives the mHealth approach. Outcomes include medication
      adherence, hemoglobin A1c, blood pressure, and LDL-cholesterol levels. The specific aims
      include: (1) evaluate the effectiveness of an mHealth diabetes adherence support intervention
      delivered by clinical pharmacists and health coaches to African-American and Latino adults
      with uncontrolled type 2 diabetes; (2) evaluate the maintenance of improved diabetes
      behaviors as well as clinical outcomes one year after completing the intervention; (3)
      evaluate the cost and cost-effectiveness of mHealth diabetes adherence support compared to
      usual care; and (4) evaluate the reach, adoption, and implementation of mHealth diabetes
      adherence support based on the RE-AIM framework.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A 2-arm, parallel, randomized controlled trial. Patients are randomized 1:1 to (1) mHealth diabetes adherence support intervention for one year and monitored with usual care for the second year, or (2) wait-list usual care for one year, then intervention during the second year.
primary purpose: Health Services Research
masking: None (Open Label)
measure: Hemoglobin A1c
time frame: 24 months
measure: Self-reported medication adherence
time frame: 24 months
description: A 3-item questionnaire will be administered to measure adherence to diabetes medications.
measure: Blood Pressure
time frame: 24 months
measure: LDL Cholesterol
time frame: 24 months
description: LDL Cholesterol will be measured as part of a Full Lipid profile blood test.
measure: Diabetes Self-Management
time frame: 24 months
description: Self-management will be measured by the revised 11-item Summary of Diabetes Self Care Activities questionnaire.
measure: Health related quality of life
time frame: 24 months
description: General health-related quality of life will be measured by the EuroQOL 5D (EQ-5D).
measure: Diabetes related quality of life
time frame: 24 months
description: Diabetes-related quality of life will be measured by the Diabetes Distress Screening Instrument (DDS4).
measure: Depression
time frame: 24 months
description: Measured with the nine-item Patient Health Questionnaire (PHQ-9)
measure: Alcohol Misuse
time frame: 24 months
description: Measured using the 3-item AUDIT-C questionnaire
measure: BMI
time frame: 24 months
description: Height and weight will be taken at each time point to determine BMI
measure: Social Support
time frame: 24 months
description: 4-item questionnaire measuring satisfaction with support from friends, family and health care team
measure: Diabetes Self-efficacy
time frame: 24 months
description: 8 -item questionnaire measuring confidence in diabetes self-management skills
measure: Healthcare utilization
time frame: 24 months
description: This will include costs associated with hospital admissions, emergency room and outpatient visits and prescription medications.
measure: Program cost
time frame: 24 months
description: This will include costs associated with the intervention including pharmacists and health coaches (training, salaries, implementation), educational materials, tablet computers and associated data service, text messaging and videoconferencing.
measure: Health Coach Satisfaction
time frame: 1 year after health coach assignment
description: A survey administered to the patient for feedback on their assigned health coach.
arm group label: Usual Care
arm group type: No Intervention
description: Participants will receive their usual care for the first year of their enrollment in the study. They will receive a referral to a diabetes educator and a clinical pharmacist, a one-page sheet of contact information for their healthcare providers, and paper-based, low-literacy diabetes information. After one year, they will change to the mDAS intervention arm for one year.
arm group label: mHealth for Diabetes Adherence Support
arm group type: Experimental
description: Participants will receive in-person support from a health coach and a clinical pharmacist with whom they will meet with regularly via videoconference. After one year, participants who have completed the mDAS intervention will be monitored for an additional year with usual care to evaluate maintenance.
intervention type: Behavioral
intervention name: mHealth for Diabetes Adherence Support
description: Participants will be paired with a health coach who will provide ongoing support and resources in medication and lifestyle adherence and diabetes self-management. The health coach will perform regular home visits, telephone support and tailored text-messages based on the participant's preferences and needs. They will help assess barriers to adherence and use motivational interviewing to help patients set goals and create action plans. They will also facilitate videoconferences with an assigned clinical pharmacist who will provide consultation on medication use, reconciliation and adherence, identify therapeutic goals and formulate an approved plan of care.
arm group label: mHealth for Diabetes Adherence Support
other name: mDAS
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ben S Gerber, MD, MPH
role: Principal Investigator
affiliation: University of Illinois at Chicago
last name: Lisa K Sharp, PhD
role: Principal Investigator
affiliation: University of Illinois at Chicago
facility: 
country: United States
citation: Sharp LK, Biggers A, Perez R, Henkins J, Tilton J, Gerber BS. A Pharmacist and Health Coach-Delivered Mobile Health Intervention for Type 2 Diabetes: Protocol for a Randomized Controlled Crossover Study. JMIR Res Protoc. 2021 Mar 10;10(3):e17170. doi: 10.2196/17170.
PMID: 33688847
responsible party type: Principal Investigator
investigator affiliation: University of Illinois at Chicago
investigator full name: Ben Gerber
investigator title: Professor of Medicine
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No