<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/NCT01695278</url>
  </required_header>
  <id_info>
    <org_study_id>STU00068025</org_study_id>
    <nct_id>NCT01695278</nct_id>
  </id_info>
  <brief_title>A Pilot Intervention Study of Health Coaching to Promote Diabetes Self-Care in the Community</brief_title>
  <acronym>C4C</acronym>
  <official_title>Coaching for Control: A Pilot Intervention Study of Health Coaching to Promote Diabetes Self-Care in the Community</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Diabetes Action Research and Education Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diabetes poses a substantial burden to racial/ethnic minorities and in populations with&#xD;
      limited access to healthcare. However, there is a shortage of healthcare providers available&#xD;
      to help patients adopt the lifestyle changes required for diabetes control. The goal of the&#xD;
      present study is to evaluate the feasibility and effectiveness of a diabetes self-care&#xD;
      intervention delivered by medical students to patients with poorly controlled diabetes.&#xD;
      Training medical students to use proven communication techniques to help patients identify&#xD;
      and overcome barriers to adopting lifestyle changes in diabetes is a novel but plausible&#xD;
      strategy. The investigators anticipate that findings from our pilot study will be used to&#xD;
      develop a larger study to definitively test the program's effectiveness. A long-term benefit&#xD;
      of our program is that future healthcare providers are practicing the skills needed to&#xD;
      promote positive lifestyle changes and provide care for chronic conditions in diverse&#xD;
      communities.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diabetes and its complications pose a substantial physical, psychological and financial&#xD;
      burden on the large number of racial/ethnic minorities and other socioeconomically deprived&#xD;
      persons with diabetes. However, self-management goals are often not met in racial/ethnic&#xD;
      minorities and in populations with fewer socioeconomic resources. In response, our research&#xD;
      team has developed a novel &quot;health coaching&quot; intervention to promote diabetes self-management&#xD;
      in the community. Health coaching is based on Control Systems Theory and helps patients to:&#xD;
      1) identify problems in self-care behaviors; 2) create dynamic plans for correcting these&#xD;
      issues; and, 3) learn to navigate the complexities of everyday life and to achieve clinically&#xD;
      and personally desirable outcomes. The primary innovation of the present project is that&#xD;
      first-year medical students are trained to serve as the health coaches, and are participating&#xD;
      in the study Coaching for Control (STU00069506). The objective of our pilot study is to test&#xD;
      whether 20 patients from five Northwestern Medicine primary care practice groups (two in the&#xD;
      Austin community, two at Northwestern Memorial Hospital and one at Norwegian American&#xD;
      Hospital) enrolled in the &quot;Coaching for Control&quot; intervention experience favorable changes in&#xD;
      clinical and behavioral outcomes after 16 weeks as compared with an equal number of patients&#xD;
      from those same clinics who are not enrolled in the program. We will use a non-randomized&#xD;
      trial design to carry out the following aims: 1. Determine whether patients with diabetes who&#xD;
      participate in the &quot;Coaching for Control&quot; behavioral intervention program (i.e., the&#xD;
      intervention arm) have lower hemoglobin A1c (HbA1c) after four months than patients who do&#xD;
      not participate in the program (i.e., the control arm). 2. Determine whether diabetes&#xD;
      patients in the intervention arm report higher task-related self-efficacy for initiating and&#xD;
      maintaining recommended diabetes self-care behaviors than participants in the control arm. We&#xD;
      hypothesize that participants in the intervention arm will have more favorable HbA1c and&#xD;
      report higher self-efficacy for diabetes self-care behaviors than participants in the control&#xD;
      arm. Secondary objectives are to test whether these changes persist 8 months after the&#xD;
      program ends and to test whether we observe changes in additional clinical measures such as&#xD;
      blood pressure, waist circumference, and in self-reported health behaviors such as medication&#xD;
      adherence, self-care behaviors, physical activity and diet. Process evaluations through focus&#xD;
      groups and interviews with participants will allow us to refine our intervention. The&#xD;
      translational aspects of our proposal include the application of a proven intervention to&#xD;
      promote diabetes self-care in a community setting that includes adults at high risk for&#xD;
      diabetes complications. Findings from the present pilot study will be used to justify&#xD;
      expansion of the study to a larger group of community members so that we can carry out a&#xD;
      larger randomized trial of efficacy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in hemoglobin A1c</measure>
    <time_frame>16 weeks</time_frame>
    <description>Changes in hemoglobin A1c between baseline and the end of follow-up will be compared between participants in the intervention arm vs. the control arm.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Task related self-efficacy for initiating and maintaining diabetes self-management</measure>
    <time_frame>16 weeks</time_frame>
    <description>Determine whether diabetes patients in the intervention arm report higher task-related self-efficacy for initiating and maintaining recommended diabetes self-care behaviors than participants in the wait list control arm.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Diabetes self-management behaviors</measure>
    <time_frame>16 weeks</time_frame>
    <description>To describe differences in diabetes self-management behavior in participants in the intervention as compared with the wait list control arm</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Diabetes Complications</condition>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive standard care from physicians for monitoring and treating their diabetes. They are placed on a wait list to receive the intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Telephone Counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Weekly telephone counseling intervention for 16 weeks, used to identify and overcome barriers to diabetes control and set goals for positive behavioral changes supplemented by monthly group classes on skill development.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telephone Counseling</intervention_name>
    <description>Weekly telephone counseling intervention for 16 weeks, used to identify and overcome barriers to diabetes control and set goals for positive behavioral changes supplemented by monthly group classes on skill development.</description>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_label>Telephone Counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt; 18 years old,&#xD;
&#xD;
          -  diagnosis of diabetes&#xD;
&#xD;
          -  ability to read and understand English,&#xD;
&#xD;
          -  access to a personal telephone,&#xD;
&#xD;
          -  intent to remain in the medical practice group for at least 1 year,&#xD;
&#xD;
          -  intention to remain in the Chicago, IL area or surrounding suburbs for 1 year.&#xD;
&#xD;
          -  Ability to read and understand the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  primary diagnosis of gestational diabetes or type 1 diabetes&#xD;
&#xD;
          -  severe mental impairment,&#xD;
&#xD;
          -  primary preferred language other than English&#xD;
&#xD;
          -  severe comorbidity with a life expectancy of &lt; 1 year&#xD;
&#xD;
          -  currently enrolled in another counseling-based diabetes intervention program&#xD;
&#xD;
          -  prior participation in the Coaching for Control intervention development in 2012&#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>Mercedes R Carnethon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>November 19, 2014</last_update_submitted>
  <last_update_submitted_qc>November 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Mercedes Carnethon</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>motivational interviewing</keyword>
  <keyword>telephone counseling</keyword>
  <keyword>medical education</keyword>
  <keyword>diabetes self management</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>
    <mesh_term>Diabetes Complications</mesh_term>
  </condition_browse>
  <!-- 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/NCT01695278
org study id: STU00068025
nct id: NCT01695278
lead sponsor: 
collaborator: 
has dmc: No
Diabetes poses a substantial burden to racial/ethnic minorities and in populations with
      limited access to healthcare. However, there is a shortage of healthcare providers available
      to help patients adopt the lifestyle changes required for diabetes control. The goal of the
      present study is to evaluate the feasibility and effectiveness of a diabetes self-care
      intervention delivered by medical students to patients with poorly controlled diabetes.
      Training medical students to use proven communication techniques to help patients identify
      and overcome barriers to adopting lifestyle changes in diabetes is a novel but plausible
      strategy. The investigators anticipate that findings from our pilot study will be used to
      develop a larger study to definitively test the program's effectiveness. A long-term benefit
      of our program is that future healthcare providers are practicing the skills needed to
      promote positive lifestyle changes and provide care for chronic conditions in diverse
      communities.
Diabetes and its complications pose a substantial physical, psychological and financial
      burden on the large number of racial/ethnic minorities and other socioeconomically deprived
      persons with diabetes. However, self-management goals are often not met in racial/ethnic
      minorities and in populations with fewer socioeconomic resources. In response, our research
      team has developed a novel "health coaching" intervention to promote diabetes self-management
      in the community. Health coaching is based on Control Systems Theory and helps patients to:
      1) identify problems in self-care behaviors; 2) create dynamic plans for correcting these
      issues; and, 3) learn to navigate the complexities of everyday life and to achieve clinically
      and personally desirable outcomes. The primary innovation of the present project is that
      first-year medical students are trained to serve as the health coaches, and are participating
      in the study Coaching for Control (STU00069506). The objective of our pilot study is to test
      whether 20 patients from five Northwestern Medicine primary care practice groups (two in the
      Austin community, two at Northwestern Memorial Hospital and one at Norwegian American
      Hospital) enrolled in the "Coaching for Control" intervention experience favorable changes in
      clinical and behavioral outcomes after 16 weeks as compared with an equal number of patients
      from those same clinics who are not enrolled in the program. We will use a non-randomized
      trial design to carry out the following aims: 1. Determine whether patients with diabetes who
      participate in the "Coaching for Control" behavioral intervention program (i.e., the
      intervention arm) have lower hemoglobin A1c (HbA1c) after four months than patients who do
      not participate in the program (i.e., the control arm). 2. Determine whether diabetes
      patients in the intervention arm report higher task-related self-efficacy for initiating and
      maintaining recommended diabetes self-care behaviors than participants in the control arm. We
      hypothesize that participants in the intervention arm will have more favorable HbA1c and
      report higher self-efficacy for diabetes self-care behaviors than participants in the control
      arm. Secondary objectives are to test whether these changes persist 8 months after the
      program ends and to test whether we observe changes in additional clinical measures such as
      blood pressure, waist circumference, and in self-reported health behaviors such as medication
      adherence, self-care behaviors, physical activity and diet. Process evaluations through focus
      groups and interviews with participants will allow us to refine our intervention. The
      translational aspects of our proposal include the application of a proven intervention to
      promote diabetes self-care in a community setting that includes adults at high risk for
      diabetes complications. Findings from the present pilot study will be used to justify
      expansion of the study to a larger group of community members so that we can carry out a
      larger randomized trial of efficacy.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in hemoglobin A1c
time frame: 16 weeks
description: Changes in hemoglobin A1c between baseline and the end of follow-up will be compared between participants in the intervention arm vs. the control arm.
measure: Task related self-efficacy for initiating and maintaining diabetes self-management
time frame: 16 weeks
description: Determine whether diabetes patients in the intervention arm report higher task-related self-efficacy for initiating and maintaining recommended diabetes self-care behaviors than participants in the wait list control arm.
measure: Diabetes self-management behaviors
time frame: 16 weeks
description: To describe differences in diabetes self-management behavior in participants in the intervention as compared with the wait list control arm
arm group label: Standard Care
arm group type: Active Comparator
description: Participants will receive standard care from physicians for monitoring and treating their diabetes. They are placed on a wait list to receive the intervention.
arm group label: Telephone Counseling
arm group type: Experimental
description: Weekly telephone counseling intervention for 16 weeks, used to identify and overcome barriers to diabetes control and set goals for positive behavioral changes supplemented by monthly group classes on skill development.
intervention type: Behavioral
intervention name: Telephone Counseling
description: Weekly telephone counseling intervention for 16 weeks, used to identify and overcome barriers to diabetes control and set goals for positive behavioral changes supplemented by monthly group classes on skill development.
arm group label: Standard Care
arm group label: Telephone Counseling
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mercedes R Carnethon, PhD
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Mercedes Carnethon
investigator title: Associate Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Diabetes Complications