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/NCT06003634</url>
    </required_header>
    <id_info>
      <org_study_id>83904</org_study_id>
      <secondary_id>R01DK135885-01</secondary_id>
      <nct_id>NCT06003634</nct_id>
    </id_info>
    <brief_title>OASIS: Peer Support for T2DM in Appalachia</brief_title>
    <acronym>OASIS</acronym>
    <official_title>Older Adults Using Social Support to Improve Self-Care: Adaptation, Implementation, and Feasibility of Peer Support for Older Adults With T2DM in Appalachia.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Brittany L Smalls</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 Kentucky</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to compare the effects of peer coaching models in older&#xD;
        adults with unmanaged type two diabetes. The main questions it aims to answer are:&#xD;
  &#xD;
          -  Are peer coaching models effective at promoting Type 2 Diabetes Mellitus&#xD;
             self-management?&#xD;
  &#xD;
          -  If effective, which facets of the peer model are most effective? Peer coaches will&#xD;
  &#xD;
          -  Undergo peer coach training.&#xD;
  &#xD;
          -  Reach out to peer participants on a weekly/biweekly time frame to discuss&#xD;
             self-management and goal setting.&#xD;
  &#xD;
          -  Retain records of contact, topics discussed, and general notes on interactions.&#xD;
             Researchers will compare differences in the frequency of contact, as well as how peer&#xD;
             coaches were matched to peer participants to see if efficacy of the intervention is&#xD;
             altered between groups.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The Older Adults using Social Support to Improve Self-Care (OASIS) intervention is an&#xD;
        asset-based approach, utilizing the unique social structure existing in Kentucky's rural&#xD;
        Appalachian communities to address self-care behaviors as they relate to Type 2 Diabetes&#xD;
        Mellitus (T2DM) management. The intervention will be composed of two groups: peer coaches who&#xD;
        have managed T2DM (HbA1c &lt; 7.5%), and peer participants who have unmanaged T2DM (HbA1c&gt;&#xD;
        7.5%). Peer coaches will undergo training prior to intervention initiation to develop&#xD;
        coaching skills. Peer participants will be linked to a peer coach in one of four ways: (1)&#xD;
        self-select coach with contact once a week (2) self-selected coach with contact every 2 weeks&#xD;
        (3) matched with peer coach with contact once a week (4) matched with peer coach with contact&#xD;
        every 2 weeks. In addition to evaluating the effectiveness of a peer coaching model, the four&#xD;
        groups will be evaluated allowing for a more detailed understanding of factors that influence&#xD;
        self-care behaviors. Stakeholders will also be engaged at three time points: prior to the&#xD;
        intervention, study mid-point, and at study conclusion. At study conclusion, a small cohort&#xD;
        of both peer participants and peer coaches will be invited to contribute to stakeholder group&#xD;
        interviews. Information exchange with stakeholders will aid in developing a robust&#xD;
        understanding of influential factors and how to effectively promulgate the intervention.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">January 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Factorial Assignment</intervention_model>
      <intervention_model_description>Peer participants will be linked to a peer coach in one of four ways: (1) self-select coach with contact once a week (2) self-selected coach with contact every 2 weeks (3) matched with peer coach with contact once a week (4) matched with peer coach with contact every 2 weeks. Profile sheets that detail age, region of residence, hobbies etc. of each peer coach will be provided to peer participants who will then rank their top three choices. Matching will be completed by study personnel, and will be based mostly in region of residence.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants with Change in A1c</measure>
      <time_frame>Collected at Baseline, 3 month, and 6 month follow up.</time_frame>
      <description>Obtained using Point of Care assessment</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Diabetes Empowerment</measure>
      <time_frame>Collected at Baseline, 3 month, and 6 month follow up.</time_frame>
      <description>&quot;Attitudes Towards Diabetes- DES&quot;. 5 point scale ranging from 1 &quot;Strongly Agree&quot; to 5 &quot;Strongly Disagree&quot;, where lower scores indicate greater feelings of empowerment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Life Index</measure>
      <time_frame>Collected at Baseline, 3 month, and 6 month follow up.</time_frame>
      <description>&quot;EuroQofL-5D&quot; measures acts of daily living (ADL) on a five point scale ranging from 0 &quot;no&quot; problems to 5 &quot;extreme&quot; problems, where higher scores indicate lower ability to engage in ADL.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Social Support</measure>
      <time_frame>Collected at Baseline, 3 month, and 6 month follow up.</time_frame>
      <description>&quot;MOS Social Support Survey&quot; a five point scale ranging from 1 &quot;none of the time&quot; to 5 &quot;all of the time&quot; where higher scores indicate better social support.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Depression Scale</measure>
      <time_frame>Collected at Baseline, 3 month, and 6 month follow up.</time_frame>
      <description>&quot;Geriatric Depression Scale: Short Form&quot; is a binary survey where participants can select &quot;yes&quot; or &quot;no&quot;. Each &quot;yes&quot; is a singular point, if a score &gt;5 points it is suggestive about depression and warrant a follow-up comprehensive assessment. A score of greater than or equal to 10 is almost always indicative of depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Problem Areas in Diabetes</measure>
      <time_frame>Collected at Baseline, 3 month, and 6 month follow up.</time_frame>
      <description>&quot;Problem Areas In Diabetes (PAID) Scale&quot; a five point scale ranging from 0 &quot;not a problem&quot; to 4 &quot;serious problem&quot;, where a higher score indicates more problems in diabetes management.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diabetes Self-Management</measure>
      <time_frame>Collected at Baseline, 3 month, and 6 month follow up.</time_frame>
      <description>Diabetes Self-Management Questionnaire (DSMQ) is a four point scale ranging from 0 &quot;does not apply to me&quot; to 3 &quot;applies to me very much&quot;. Higher scores indicate better diabetes management.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acts of Daily Living</measure>
      <time_frame>Collected at Baseline, 3 month, and 6 month follow up.</time_frame>
      <description>&quot;Lawton-Brody Instrumental Activities of Daily Living Scale (L.A.D.L) is a binary where &quot;0&quot; is low functioning and &quot;1&quot; is high functioning. Higher scores indicate higher functioning.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Social Network Scale</measure>
      <time_frame>Collected at Baseline, 3 month, and 6 month follow up.</time_frame>
      <description>&quot;Lubbens Social Network Scale - 6 (LSNS-6) is a five point scale ranging from &quot;0&quot; none to &quot;5&quot; nine or more. Higher scores indicate greater amount of social support.</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">108</enrollment>
    <condition>Diabetes Mellitus, Type 2</condition>
    <arm_group>
      <arm_group_label>Peer Participants (A)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Peer participants in group A will self select a peer coach using peer coach profile sheets, and will be contacted weekly during intervention period.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Peer Participants (B)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Peer participants in group B will self select a peer coach using peer coach profile sheets, and will be contacted biweekly during intervention period.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Peer Participants (C)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Peer participants in group C will be matched with a peer coach by study personnel, and will be contacted weekly during intervention period.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Peer Participant (D)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Peer participants in group D will be matched with a peer coach by study personnel, and will be contacted biweekly during intervention period.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Peer Coaching - Peer Participants A</intervention_name>
      <description>Peer participants in group A will self select a peer coach and will be contacted weekly by peer coaches.</description>
      <arm_group_label>Peer Participants (A)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Peer Coaching - Peer Participants B</intervention_name>
      <description>Peer participants in group B will self select a peer coach and will be contacted bi-weekly by peer coaches.</description>
      <arm_group_label>Peer Participants (B)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Peer Coaching - Peer Participants C</intervention_name>
      <description>Peer participants in group C will be matched with a peer coach and will be contacted weekly by peer coaches.</description>
      <arm_group_label>Peer Participants (C)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Peer Coaching - Peer Participants D</intervention_name>
      <description>Peer participants in group D will be matched with a peer coach and will be contacted bi-weekly by peer coaches.</description>
      <arm_group_label>Peer Participant (D)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age greater than or equal to 55 years&#xD;
  &#xD;
            -  Resident in Rural Kentucky&#xD;
  &#xD;
            -  Positive diagnosis of Type 2 Diabetes Mellitus&#xD;
  &#xD;
            -  HbA1c greater than 7.5 for peer participants&#xD;
  &#xD;
            -  HbA1c less than 7.5 for peer coaches&#xD;
  &#xD;
            -  Passing score on cognitive assessment administered by study personnel&#xD;
  &#xD;
            -  English Speaking&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age less than 55 years&#xD;
  &#xD;
            -  Not a resident of a Rural Kentucky county&#xD;
  &#xD;
            -  Cognitive Impairment&#xD;
  &#xD;
            -  Non-English Speaking&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Brittany L Smalls, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Kentucky</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Brittany L Smalls, PhD</last_name>
      <phone>859-323-4916</phone>
      <email>Brittany.Smalls@uky.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Zoe M Taylor, MSPH</last_name>
      <phone>859-562-0757</phone>
      <email>Zoe.Taylor@uky.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University of Kentucky</investigator_affiliation>
      <investigator_full_name>Brittany L Smalls</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>Appalachian Region</keyword>
    <keyword>Peer Influence</keyword>
    <keyword>Diabetes Mellitus, Type 2</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>
  
  
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/NCT06003634
  org study id: 83904
  secondary id: R01DK135885-01
  nct id: NCT06003634
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare the effects of peer coaching models in older
        adults with unmanaged type two diabetes. The main questions it aims to answer are:
  
          -  Are peer coaching models effective at promoting Type 2 Diabetes Mellitus
             self-management?
  
          -  If effective, which facets of the peer model are most effective? Peer coaches will
  
          -  Undergo peer coach training.
  
          -  Reach out to peer participants on a weekly/biweekly time frame to discuss
             self-management and goal setting.
  
          -  Retain records of contact, topics discussed, and general notes on interactions.
             Researchers will compare differences in the frequency of contact, as well as how peer
             coaches were matched to peer participants to see if efficacy of the intervention is
             altered between groups.
  The Older Adults using Social Support to Improve Self-Care (OASIS) intervention is an
        asset-based approach, utilizing the unique social structure existing in Kentucky's rural
        Appalachian communities to address self-care behaviors as they relate to Type 2 Diabetes
        Mellitus (T2DM) management. The intervention will be composed of two groups: peer coaches who
        have managed T2DM (HbA1c < 7.5%), and peer participants who have unmanaged T2DM (HbA1c>
        7.5%). Peer coaches will undergo training prior to intervention initiation to develop
        coaching skills. Peer participants will be linked to a peer coach in one of four ways: (1)
        self-select coach with contact once a week (2) self-selected coach with contact every 2 weeks
        (3) matched with peer coach with contact once a week (4) matched with peer coach with contact
        every 2 weeks. In addition to evaluating the effectiveness of a peer coaching model, the four
        groups will be evaluated allowing for a more detailed understanding of factors that influence
        self-care behaviors. Stakeholders will also be engaged at three time points: prior to the
        intervention, study mid-point, and at study conclusion. At study conclusion, a small cohort
        of both peer participants and peer coaches will be invited to contribute to stakeholder group
        interviews. Information exchange with stakeholders will aid in developing a robust
        understanding of influential factors and how to effectively promulgate the intervention.
  allocation: Non-Randomized
  intervention model: Factorial Assignment
  intervention model description: Peer participants will be linked to a peer coach in one of four ways: (1) self-select coach with contact once a week (2) self-selected coach with contact every 2 weeks (3) matched with peer coach with contact once a week (4) matched with peer coach with contact every 2 weeks. Profile sheets that detail age, region of residence, hobbies etc. of each peer coach will be provided to peer participants who will then rank their top three choices. Matching will be completed by study personnel, and will be based mostly in region of residence.
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Number of Participants with Change in A1c
  time frame: Collected at Baseline, 3 month, and 6 month follow up.
  description: Obtained using Point of Care assessment
  measure: Diabetes Empowerment
  time frame: Collected at Baseline, 3 month, and 6 month follow up.
  description: "Attitudes Towards Diabetes- DES". 5 point scale ranging from 1 "Strongly Agree" to 5 "Strongly Disagree", where lower scores indicate greater feelings of empowerment.
  measure: Quality of Life Index
  time frame: Collected at Baseline, 3 month, and 6 month follow up.
  description: "EuroQofL-5D" measures acts of daily living (ADL) on a five point scale ranging from 0 "no" problems to 5 "extreme" problems, where higher scores indicate lower ability to engage in ADL.
  measure: Social Support
  time frame: Collected at Baseline, 3 month, and 6 month follow up.
  description: "MOS Social Support Survey" a five point scale ranging from 1 "none of the time" to 5 "all of the time" where higher scores indicate better social support.
  measure: Depression Scale
  time frame: Collected at Baseline, 3 month, and 6 month follow up.
  description: "Geriatric Depression Scale: Short Form" is a binary survey where participants can select "yes" or "no". Each "yes" is a singular point, if a score >5 points it is suggestive about depression and warrant a follow-up comprehensive assessment. A score of greater than or equal to 10 is almost always indicative of depression.
  measure: Problem Areas in Diabetes
  time frame: Collected at Baseline, 3 month, and 6 month follow up.
  description: "Problem Areas In Diabetes (PAID) Scale" a five point scale ranging from 0 "not a problem" to 4 "serious problem", where a higher score indicates more problems in diabetes management.
  measure: Diabetes Self-Management
  time frame: Collected at Baseline, 3 month, and 6 month follow up.
  description: Diabetes Self-Management Questionnaire (DSMQ) is a four point scale ranging from 0 "does not apply to me" to 3 "applies to me very much". Higher scores indicate better diabetes management.
  measure: Acts of Daily Living
  time frame: Collected at Baseline, 3 month, and 6 month follow up.
  description: "Lawton-Brody Instrumental Activities of Daily Living Scale (L.A.D.L) is a binary where "0" is low functioning and "1" is high functioning. Higher scores indicate higher functioning.
  measure: Social Network Scale
  time frame: Collected at Baseline, 3 month, and 6 month follow up.
  description: "Lubbens Social Network Scale - 6 (LSNS-6) is a five point scale ranging from "0" none to "5" nine or more. Higher scores indicate greater amount of social support.
  arm group label: Peer Participants (A)
  arm group type: Experimental
  description: Peer participants in group A will self select a peer coach using peer coach profile sheets, and will be contacted weekly during intervention period.
  arm group label: Peer Participants (B)
  arm group type: Experimental
  description: Peer participants in group B will self select a peer coach using peer coach profile sheets, and will be contacted biweekly during intervention period.
  arm group label: Peer Participants (C)
  arm group type: Experimental
  description: Peer participants in group C will be matched with a peer coach by study personnel, and will be contacted weekly during intervention period.
  arm group label: Peer Participant (D)
  arm group type: Experimental
  description: Peer participants in group D will be matched with a peer coach by study personnel, and will be contacted biweekly during intervention period.
  intervention type: Behavioral
  intervention name: Peer Coaching - Peer Participants A
  description: Peer participants in group A will self select a peer coach and will be contacted weekly by peer coaches.
  arm group label: Peer Participants (A)
  intervention type: Behavioral
  intervention name: Peer Coaching - Peer Participants B
  description: Peer participants in group B will self select a peer coach and will be contacted bi-weekly by peer coaches.
  arm group label: Peer Participants (B)
  intervention type: Behavioral
  intervention name: Peer Coaching - Peer Participants C
  description: Peer participants in group C will be matched with a peer coach and will be contacted weekly by peer coaches.
  arm group label: Peer Participants (C)
  intervention type: Behavioral
  intervention name: Peer Coaching - Peer Participants D
  description: Peer participants in group D will be matched with a peer coach and will be contacted bi-weekly by peer coaches.
  arm group label: Peer Participant (D)
  criteria: 
  gender: All
  minimum age: 55 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Brittany L Smalls, PhD
  role: Principal Investigator
  affiliation: University of Kentucky
  last name: Brittany L Smalls, PhD
  phone: 859-323-4916
  email: Brittany.Smalls@uky.edu
  last name: Zoe M Taylor, MSPH
  phone: 859-562-0757
  email: Zoe.Taylor@uky.edu
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of Kentucky
  investigator full name: Brittany L Smalls
  investigator title: Associate Professor
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2