<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/NCT02247271</url>
  </required_header>
  <id_info>
    <org_study_id>2014-775-Diabetes</org_study_id>
    <nct_id>NCT02247271</nct_id>
  </id_info>
  <brief_title>The Role and Effectiveness of Diabetes Coaches in British Columbia</brief_title>
  <official_title>The Role and Effectiveness of Diabetes Coaches in British Columbia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Victoria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Lawson Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Victoria</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project is a partnership between the University of Victoria and the eleven Diabetes&#xD;
      Health Centres in the Fraser Health Region of British Columbia, Canada. The primary goal of&#xD;
      this project is to evaluate the feasibility, viability, and effectiveness of using peer&#xD;
      health coaches to assist persons with type 2 diabetes who are experiencing challenges in&#xD;
      managing their diabetes. The University of Victoria will recruit and train sixty coaches with&#xD;
      various cultural and socioeconomic backgrounds representing a community of practice. Coaches&#xD;
      will also have type 2 diabetes or be familiar with type 2 diabetes and will have led or taken&#xD;
      the Diabetes Self-Management Program in English, Punjabi or in Aboriginal communities.&#xD;
      Training will also include navigating the health care system, accessing mandated health and&#xD;
      employment- related services, importance of medication adherence and ability to understand&#xD;
      health care instructions. One hundred and fifty subjects with type 2 diabetes will be&#xD;
      recruited by Diabetes Health Educators or through community newspaper ads. Eligibility&#xD;
      criteria for subjects include: adults with type 2 diabetes who speak English or Punjabi&#xD;
      living in the Fraser Health region. A one group pre-post matched design will be used. Both&#xD;
      participants and coaches will complete questionnaires at baseline, six and twelve months. The&#xD;
      Diabetes Coaches will provide assistance to subjects for a period of 6 months. A project&#xD;
      community advisory committee comprised of the researchers, Diabetes Centre administrative&#xD;
      staff, clinicians, coaches, subjects, key community leaders and representatives from the&#xD;
      diabetes industry will meet every three months to guide implementation and sustainability.&#xD;
      Qualitative research methods (i.e., focus groups and interviews) will be used to gather&#xD;
      feedback, perspectives, and opinions of all the stakeholders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      SUBJECT RECRUITMENT. Recruitment will take place during the first year by Diabetes Centre&#xD;
      Educators in the Fraser Health region and through community newspaper ads. In total, 150&#xD;
      subjects will be recruited, along with 60 coaches. Diabetes Centre Educators will refer&#xD;
      interested clients who will be contacted by the study coordinator. Persons responding to&#xD;
      community newspaper ads will contact the study coordinator directly. Interested subjects will&#xD;
      receive a full description of the study and confirm that they want to register. A package&#xD;
      containing the Fraser Health Consent Form and a set of questionnaires will be mailed to them.&#xD;
&#xD;
      DIABETES COACH RECRUITMENT AND TRAINING. Recruitment and training will occur in the first 6&#xD;
      months. Criteria includes: living in the Fraser Health Region, adults, having type 2 diabetes&#xD;
      or living with someone who has type 2 diabetes, and having similar cultural and ethnic&#xD;
      background as members of the community. The coaches will most likely have already completed&#xD;
      participation in a self-management program and therefore be knowledgeable in using&#xD;
      self-management support strategies.&#xD;
&#xD;
      Competency-based training will be conducted to alleviate potential health professional&#xD;
      concerns regarding the quality of service provided by non-professionals. Based on the&#xD;
      experience using health workers to assist patients with diabetes (14), our project will&#xD;
      provide a six-week training which will include:&#xD;
&#xD;
        -  self-management support strategies as per the Five As approach (15);&#xD;
&#xD;
        -  the Training Curriculum for Health Coaches (16);&#xD;
&#xD;
        -  using behavioural change strategies on exercise, eating habits, smoking, and alcohol use&#xD;
           developed by the national Service's Health Trainer Manual (17);&#xD;
&#xD;
        -  basic information on diabetes and associated chronic diseases;&#xD;
&#xD;
        -  finding and using governmental and community services;&#xD;
&#xD;
        -  navigating the health care system; and if required&#xD;
&#xD;
        -  completing the Diabetes Self-Management Program. Health coaches will undergo a final&#xD;
           exam to receive certification from the University of Victoria. Subjects will be paired&#xD;
           with a diabetes coach by the study coordinator. An innovative aspect of the proposed&#xD;
           research is that baseline outcome measures will be calculated and used to tailor the&#xD;
           coach intervention. For example one of the measures, the Patient Activation Measure&#xD;
           (18), assesses an individual's knowledge, skill and confidence in managing their health,&#xD;
           and specifies the types of interventions to increase activation. This is important&#xD;
           because a systematic review of evidence on the performance of the Patient Activation&#xD;
           Measure conducted by the National Health Service in 2012 (19) found that: higher PAM&#xD;
           scores were associated with increased patient participation, significantly better health&#xD;
           and significantly lower rates of doctor office visits, emergency room visits, and&#xD;
           hospital nights; healthy behaviours; improved adherence to treatment; and with better&#xD;
           doctor-patient communication. The study is also using other outcome measures that enable&#xD;
           the tailoring of the intervention, for example the medication adherence and health&#xD;
           literacy measures.&#xD;
&#xD;
      The coach will work with the subject by telephone for six months. Coaches will help subjects&#xD;
      gain the knowledge, skills, tools, and confidence they need to become active participants in&#xD;
      their care so that they can reach their self-identified health goals. The coach will also&#xD;
      assist the patient to participate in the Diabetes Self-Management Program, learn and use&#xD;
      effective self-management strategies (i.e., action plans and problem solving); understand and&#xD;
      follow their medication regimen; access community resources (e.g., recreation centre); and&#xD;
      receive eligible federal and provincial mandated services (e.g., income assistance,&#xD;
      disability benefits), and learn about and use community resources (e.g., recreation centres),&#xD;
      and assist the patient to use mandated services (e.g., income assistance).&#xD;
&#xD;
      With respect to innovation, it is time to tap the (largely) untapped resource of peer support&#xD;
      to deal with the burden of diabetes (20). According to the World Health Organization,&#xD;
      patients and families are the most undervalued assets in the health care system (10). A&#xD;
      potential solution is to train peers to &quot; coach&quot; or work collaboratively to deliver&#xD;
      self-management support to persons with diabetes. Peer coaching is defined as &quot; helping&#xD;
      patients gain the knowledge, skills, tools, and confidence they need to become active&#xD;
      participants in their care so that they can reach their self-identified health goals&quot; (21). A&#xD;
      peer coaching intervention complements, enhances, and increases the comprehensiveness of&#xD;
      primary care services, while increasing patient centredness and reducing fragmentation of&#xD;
      care (21). While family, caretakers, friends and healthcare professionals can fill the role&#xD;
      of advisor, supporter and role model, they can rarely fulfill all three roles. Peer health&#xD;
      coaches, however, can fulfill all three roles and also benefit personally. Utilizing peer&#xD;
      advisors for chronic disease management and particularly for people with type 2 diabetes has&#xD;
      the potential to be cost effective (22). In a systematic review of the literature on peer&#xD;
      support for chronic and complex conditions, the authors found more evidence that peer&#xD;
      self-management support was effective with socially disadvantaged groups. Improved health&#xD;
      outcomes were found for a Bangladeshi and Maori community with culturally relevant peer&#xD;
      support in diabetes programs (23).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 1, 2014</start_date>
  <completion_date type="Actual">September 30, 2017</completion_date>
  <primary_completion_date type="Actual">September 30, 2017</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Activation Measure (PAM)</measure>
    <time_frame>one year</time_frame>
    <description>This is a composite measure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>glycated hemoglobin test (A1C)</measure>
    <time_frame>one year</time_frame>
    <description>Measures blood glucose level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes Empowerment Scale (DES)</measure>
    <time_frame>one year</time_frame>
    <description>Assesses subjects' perception of empowerment to manage diabetes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy</measure>
    <time_frame>one year</time_frame>
    <description>Measures confidence in managing diabetes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported health</measure>
    <time_frame>one year</time_frame>
    <description>Assess subjects' perception of their health status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>one year</time_frame>
    <description>Assesses subjects' perception of fatigue level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>one year</time_frame>
    <description>Assesses subjects' perception of pain level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire (PHQ-9) Depression Scale</measure>
    <time_frame>one year</time_frame>
    <description>Assesses subjects' perception of depression experience</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Communication with physician</measure>
    <time_frame>one year</time_frame>
    <description>Assesses' subjects' communication with their doctor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication Adherence scale</measure>
    <time_frame>one year</time_frame>
    <description>Measures subjects' adherence to prescribed medication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chow 3 question health literacy scale</measure>
    <time_frame>one year</time_frame>
    <description>Measures health literacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported healthcare utilization</measure>
    <time_frame>one year</time_frame>
    <description>Self-report number of doctor visits, emergency room visits, and nights in hospital</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <arm_group>
    <arm_group_label>Diabetes health coach support</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The intervention is that subjects will receive coach support once a week for 30 minutes for six months. Support is provided by a Diabetes Coach who uses self-management support strategies to assist subjects to achieve their personal health goals.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Diabetes health coach support</intervention_name>
    <description>Receives support from a trained peer health coach for a six month period</description>
    <arm_group_label>Diabetes health coach support</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults, living in Fraser Health Region of British Columbia, type 2 diabetes, ability&#xD;
             to speak English or Punjabi&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Type 1 diabetes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrick T McGowan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Victoria</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UVictoria</name>
      <address>
        <city>Delta</city>
        <state>British Columbia</state>
        <zip>V4K 2K6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://www.selfmanagementbc.ca/uploads/Common/References.pdf</url>
    <description>Study proposal citations</description>
  </link>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>May 1, 2018</last_update_submitted>
  <last_update_submitted_qc>May 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Victoria</investigator_affiliation>
    <investigator_full_name>Patrick T. McGowan, PhD</investigator_full_name>
    <investigator_title>Professor, School of Public Health and Social Policy</investigator_title>
  </responsible_party>
  <keyword>peer coaches</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>
  <!-- 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/NCT02247271
org study id: 2014-775-Diabetes
nct id: NCT02247271
lead sponsor: 
collaborator: 
has dmc: No
This project is a partnership between the University of Victoria and the eleven Diabetes
      Health Centres in the Fraser Health Region of British Columbia, Canada. The primary goal of
      this project is to evaluate the feasibility, viability, and effectiveness of using peer
      health coaches to assist persons with type 2 diabetes who are experiencing challenges in
      managing their diabetes. The University of Victoria will recruit and train sixty coaches with
      various cultural and socioeconomic backgrounds representing a community of practice. Coaches
      will also have type 2 diabetes or be familiar with type 2 diabetes and will have led or taken
      the Diabetes Self-Management Program in English, Punjabi or in Aboriginal communities.
      Training will also include navigating the health care system, accessing mandated health and
      employment- related services, importance of medication adherence and ability to understand
      health care instructions. One hundred and fifty subjects with type 2 diabetes will be
      recruited by Diabetes Health Educators or through community newspaper ads. Eligibility
      criteria for subjects include: adults with type 2 diabetes who speak English or Punjabi
      living in the Fraser Health region. A one group pre-post matched design will be used. Both
      participants and coaches will complete questionnaires at baseline, six and twelve months. The
      Diabetes Coaches will provide assistance to subjects for a period of 6 months. A project
      community advisory committee comprised of the researchers, Diabetes Centre administrative
      staff, clinicians, coaches, subjects, key community leaders and representatives from the
      diabetes industry will meet every three months to guide implementation and sustainability.
      Qualitative research methods (i.e., focus groups and interviews) will be used to gather
      feedback, perspectives, and opinions of all the stakeholders.
SUBJECT RECRUITMENT. Recruitment will take place during the first year by Diabetes Centre
      Educators in the Fraser Health region and through community newspaper ads. In total, 150
      subjects will be recruited, along with 60 coaches. Diabetes Centre Educators will refer
      interested clients who will be contacted by the study coordinator. Persons responding to
      community newspaper ads will contact the study coordinator directly. Interested subjects will
      receive a full description of the study and confirm that they want to register. A package
      containing the Fraser Health Consent Form and a set of questionnaires will be mailed to them.

      DIABETES COACH RECRUITMENT AND TRAINING. Recruitment and training will occur in the first 6
      months. Criteria includes: living in the Fraser Health Region, adults, having type 2 diabetes
      or living with someone who has type 2 diabetes, and having similar cultural and ethnic
      background as members of the community. The coaches will most likely have already completed
      participation in a self-management program and therefore be knowledgeable in using
      self-management support strategies.

      Competency-based training will be conducted to alleviate potential health professional
      concerns regarding the quality of service provided by non-professionals. Based on the
      experience using health workers to assist patients with diabetes (14), our project will
      provide a six-week training which will include:

        -  self-management support strategies as per the Five As approach (15);

        -  the Training Curriculum for Health Coaches (16);

        -  using behavioural change strategies on exercise, eating habits, smoking, and alcohol use
           developed by the national Service's Health Trainer Manual (17);

        -  basic information on diabetes and associated chronic diseases;

        -  finding and using governmental and community services;

        -  navigating the health care system; and if required

        -  completing the Diabetes Self-Management Program. Health coaches will undergo a final
           exam to receive certification from the University of Victoria. Subjects will be paired
           with a diabetes coach by the study coordinator. An innovative aspect of the proposed
           research is that baseline outcome measures will be calculated and used to tailor the
           coach intervention. For example one of the measures, the Patient Activation Measure
           (18), assesses an individual's knowledge, skill and confidence in managing their health,
           and specifies the types of interventions to increase activation. This is important
           because a systematic review of evidence on the performance of the Patient Activation
           Measure conducted by the National Health Service in 2012 (19) found that: higher PAM
           scores were associated with increased patient participation, significantly better health
           and significantly lower rates of doctor office visits, emergency room visits, and
           hospital nights; healthy behaviours; improved adherence to treatment; and with better
           doctor-patient communication. The study is also using other outcome measures that enable
           the tailoring of the intervention, for example the medication adherence and health
           literacy measures.

      The coach will work with the subject by telephone for six months. Coaches will help subjects
      gain the knowledge, skills, tools, and confidence they need to become active participants in
      their care so that they can reach their self-identified health goals. The coach will also
      assist the patient to participate in the Diabetes Self-Management Program, learn and use
      effective self-management strategies (i.e., action plans and problem solving); understand and
      follow their medication regimen; access community resources (e.g., recreation centre); and
      receive eligible federal and provincial mandated services (e.g., income assistance,
      disability benefits), and learn about and use community resources (e.g., recreation centres),
      and assist the patient to use mandated services (e.g., income assistance).

      With respect to innovation, it is time to tap the (largely) untapped resource of peer support
      to deal with the burden of diabetes (20). According to the World Health Organization,
      patients and families are the most undervalued assets in the health care system (10). A
      potential solution is to train peers to " coach" or work collaboratively to deliver
      self-management support to persons with diabetes. Peer coaching is defined as " helping
      patients gain the knowledge, skills, tools, and confidence they need to become active
      participants in their care so that they can reach their self-identified health goals" (21). A
      peer coaching intervention complements, enhances, and increases the comprehensiveness of
      primary care services, while increasing patient centredness and reducing fragmentation of
      care (21). While family, caretakers, friends and healthcare professionals can fill the role
      of advisor, supporter and role model, they can rarely fulfill all three roles. Peer health
      coaches, however, can fulfill all three roles and also benefit personally. Utilizing peer
      advisors for chronic disease management and particularly for people with type 2 diabetes has
      the potential to be cost effective (22). In a systematic review of the literature on peer
      support for chronic and complex conditions, the authors found more evidence that peer
      self-management support was effective with socially disadvantaged groups. Improved health
      outcomes were found for a Bangladeshi and Maori community with culturally relevant peer
      support in diabetes programs (23).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Patient Activation Measure (PAM)
time frame: one year
description: This is a composite measure
measure: glycated hemoglobin test (A1C)
time frame: one year
description: Measures blood glucose level
measure: Diabetes Empowerment Scale (DES)
time frame: one year
description: Assesses subjects' perception of empowerment to manage diabetes
measure: Self-efficacy
time frame: one year
description: Measures confidence in managing diabetes
measure: Self-reported health
time frame: one year
description: Assess subjects' perception of their health status
measure: Fatigue
time frame: one year
description: Assesses subjects' perception of fatigue level
measure: Pain
time frame: one year
description: Assesses subjects' perception of pain level
measure: Patient Health Questionnaire (PHQ-9) Depression Scale
time frame: one year
description: Assesses subjects' perception of depression experience
measure: Communication with physician
time frame: one year
description: Assesses' subjects' communication with their doctor
measure: Medication Adherence scale
time frame: one year
description: Measures subjects' adherence to prescribed medication
measure: Chow 3 question health literacy scale
time frame: one year
description: Measures health literacy
measure: Self-reported healthcare utilization
time frame: one year
description: Self-report number of doctor visits, emergency room visits, and nights in hospital
arm group label: Diabetes health coach support
arm group type: Other
description: The intervention is that subjects will receive coach support once a week for 30 minutes for six months. Support is provided by a Diabetes Coach who uses self-management support strategies to assist subjects to achieve their personal health goals.
intervention type: Behavioral
intervention name: Diabetes health coach support
description: Receives support from a trained peer health coach for a six month period
arm group label: Diabetes health coach support
criteria: 
gender: All
minimum age: 19 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Patrick T McGowan, PhD
role: Principal Investigator
affiliation: University of Victoria
facility: 
country: Canada
url: http://www.selfmanagementbc.ca/uploads/Common/References.pdf
description: Study proposal citations
responsible party type: Principal Investigator
investigator affiliation: University of Victoria
investigator full name: Patrick T. McGowan, PhD
investigator title: Professor, School of Public Health and Social Policy
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2