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/NCT06004219</url>
    </required_header>
    <id_info>
      <org_study_id>IRB:00002372</org_study_id>
      <nct_id>NCT06004219</nct_id>
    </id_info>
    <brief_title>Peer Support for Patients With Diabetic Foot Ulcers</brief_title>
    <official_title>Peer Support in Patients With Diabetic Foot Ulceration</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Casa Colina Hospital and Centers for Healthcare</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Southern California</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Vascular Cures</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Department of Health and Human Services</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
      <collaborator>
        <agency>Rancho Los Amigos National Rehabilitation Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Casa Colina Hospital and Centers for Healthcare</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 objective of the study is to develop a peer support program that helps improve ulcer care&#xD;
        in patients with a diabetic foot ulcer (DFU).Diabetes, peripheral arterial disease (PAD),&#xD;
        foot ulceration, and subsequent amputation are unevenly patterned in terms of&#xD;
        racial/ethnicity, socioeconomic status, health insurance, and geographic area. The project&#xD;
        will identify opportunities to reduce health disparities among economically marginalized&#xD;
        patients regarding DFU outcomes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Of the estimated 30 million people in the U.S. with diabetes, 34% will develop a DFU in their&#xD;
        lifetime, and 50% of those with a DFU have concurrent PAD. Foot ulceration, which precedes&#xD;
        80% of amputations in diabetics, is associated with impaired physical function, reduced&#xD;
        quality of life, and increased risk of death. Moreover, PAD, DFU, and subsequent major&#xD;
        amputations are unevenly patterned in terms of racial/ethnic, SES, health insurance, and&#xD;
        geographic status. More specifically, Black and Hispanic adults with an ischemic DFU have a&#xD;
        higher prevalence of amputation than their White counterparts. The mechanisms of these&#xD;
        observed disparities in amputation, beyond disease severity and comorbidities, are complex.&#xD;
        However, evidence indicates that ulcer care (including wound care, diabetic shoe, offloading,&#xD;
        and recognizing warning signs) is a significant challenge for low-income patients with an&#xD;
        ischemic DFU. In addition, our team and other researchers have demonstrated how&#xD;
        psychological, interpersonal, social, and healthcare system-level barriers limit appropriate&#xD;
        ulcer and foot care. Furthermore, our qualitative data demonstrates a high rate of&#xD;
        psychological and interpersonal factors to diabetic foot care that cannot be ignored.&#xD;
        Clearly, there is a compelling need for innovative methods to improve DFU care that are based&#xD;
        on health equity that led to diverse support. To address this gap, we propose a&#xD;
        patient-centered and culturally tailored Peer-Pal Intervention (PPI) that helps promote ulcer&#xD;
        care in patients with a DFU, while minimizing the burden placed on system resources.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 21, 2023</start_date>
    <completion_date type="Anticipated">January 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 2024</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>Parallel Assignment</intervention_model>
      <intervention_model_description>We will assign 12 patients into peer support group (intervention) and 12 patients as control (usual care with no support group) group. Patients will be followed for 6 months.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>VascuQoL-6</measure>
      <time_frame>Complete at enrollment visit</time_frame>
      <description>A self-reported survey or questionnaire that facilitates health-related quality of life assessment in peripheral arterial disease. Each question is scored 1-4. The sum of each individual question is used to generate a &quot;Total&quot; Quality of Life Score. A higher value indicates better health status.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>VascuQoL-6</measure>
      <time_frame>Complete at 3 month visit</time_frame>
      <description>A self-reported survey or questionnaire that facilitates health-related quality of life assessment in peripheral arterial disease. Each question is scored 1-4. The sum of each individual question is used to generate a &quot;Total&quot; Quality of Life Score. A higher value indicates better health status.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>VascuQoL-6</measure>
      <time_frame>Complete at 6 month visit, end of study</time_frame>
      <description>A self-reported survey or questionnaire that facilitates health-related quality of life assessment in peripheral arterial disease. Each question is scored 1-4. The sum of each individual question is used to generate a &quot;Total&quot; Quality of Life Score. A higher value indicates better health status.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PROMIS (Patient Reported Outcomes Measurement Information System)</measure>
      <time_frame>Complete at enrollment visit</time_frame>
      <description>Set of person-centered measures which evaluates and monitors physical, mental and social health in adults. It will be administered using a computer adaptive test (CAT) where items are selected for administration from an item bank based upon the respondent's answers. Items are ordered by level of difficulty from low to high using the Item Response Theory. After a person provides a response, the estimated score is recalculated. The CAT continues to administer items until stopping rules are met. The stopping rules for adults are as follows: at least 4 items administered, 12-items are administered or the standard error is below a threshold (0.3 on the theta metric or 3.0 on the T-score metric).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PROMIS (Patient Reported Outcomes Measurement Information System)</measure>
      <time_frame>Complete at 3 month visit</time_frame>
      <description>Set of person-centered measures which evaluates and monitors physical, mental and social health in adults. It will be administered using a computer adaptive test (CAT) where items are selected for administration from an item bank based upon the respondent's answers. Items are ordered by level of difficulty from low to high using the Item Response Theory. After a person provides a response, the estimated score is recalculated. The CAT continues to administer items until stopping rules are met. The stopping rules for adults are as follows: at least 4 items administered, 12-items are administered or the standard error is below a threshold (0.3 on the theta metric or 3.0 on the T-score metric).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PROMIS (Patient Reported Outcomes Measurement Information System)</measure>
      <time_frame>Complete at 6 month visit, end of study</time_frame>
      <description>Set of person-centered measures which evaluates and monitors physical, mental and social health in adults. It will be administered using a computer adaptive test (CAT) where items are selected for administration from an item bank based upon the respondent's answers. Items are ordered by level of difficulty from low to high using the Item Response Theory. After a person provides a response, the estimated score is recalculated. The CAT continues to administer items until stopping rules are met. The stopping rules for adults are as follows: at least 4 items administered, 12-items are administered or the standard error is below a threshold (0.3 on the theta metric or 3.0 on the T-score metric).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability Questionnaire --Peer to Pal Intervention (PPI)</measure>
      <time_frame>End of study, 6 month visit</time_frame>
      <description>5-point scale: strongly agree, agree, neutral, disagree, and strongly disagree</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Twenty Three Item Questionnaire (Heisler)</measure>
      <time_frame>End of Study, 6 month visit</time_frame>
      <description>The questionnaire is a follow-up patient assessment comprised of 23 questions derived and modified from (Heisler et al.) It is a series of open ended questions to evaluate the effectiveness and attitudes of peer support with participants who have diabetic foot ulcer.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Diabetes Distress Screening Scale (DDS17)</measure>
      <time_frame>Complete at enrollment visit</time_frame>
      <description>6-point scale: 1-not a problem, 2-slight problem, 3- moderate problem, 4-somewhat serious problem, 5-serious problem, 6-very serious problem. A mean item score of 3 or higher indicates a level of distress worthy of clinical attention.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Diabetes Distress Screening Scale (DDS17)</measure>
      <time_frame>Complete at 3 month visit</time_frame>
      <description>6-point scale: 1-not a problem, 2-slight problem, 3- moderate problem, 4-somewhat serious problem, 5-serious problem, 6-very serious problem. A mean item score of 3 or higher indicates a level of distress worthy of clinical attention.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Diabetes Distress Screening Scale (DDS17)</measure>
      <time_frame>End of study, 6 month visit</time_frame>
      <description>6-point scale: 1-not a problem, 2-slight problem, 3- moderate problem, 4-somewhat serious problem, 5-serious problem, 6-very serious problem. A mean item score of 3 or higher indicates a level of distress worthy of clinical attention.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Diabetic Foot Ulcer</condition>
    <condition>Diabetic Wound</condition>
    <condition>Diabetes Mellitus, Type 2</condition>
    <condition>Diabetic Foot</condition>
    <condition>Diabetes Complications</condition>
    <condition>Peripheral Neuropathy</condition>
    <arm_group>
      <arm_group_label>Peer Support Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will be asked to complete a health-related quality of life (HRQOL) survey at enrollment, 3 months, and end of the study. Participants will complete the VascuQoL-6 and PROMIS in several domains of HRQOL (including global physical function, global mental function, fatigue, depression, sleep disturbance, pain behavior, and social satisfaction). Each participant will complete the PROMIS CAT tool on an iPad App and the data will be stored in the secure REDCap</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual Care Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Subjects in this group will not participate in the peer group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Peer counseling group</intervention_name>
      <description>A community advisory board (CAB) will be set up for need assessment and to design the peer support program. Virtual meetings will be held quarterly for year 1 and 2. The group will consist of (up to 12 members) and will include at least 2 patient partners (patients with a recently diagnosed ulcer), 2 peer pals (patients with a healed DFU), family members or caregivers (limited to only 1 person per family represented on the CAB), healthcare workers (podiatrist, nurse, or case manager), medical equipment company representatives, and others. We will ask them about potential barriers at the first meeting, have flexible meeting times, and intentionally limit the number of healthcare providers. At the last meeting, we will seek feedback and input from the CAB. In addition, this group will have the opportunity to participate in a focus group which will be moderated with a trained, bilingual assistant and will last 40-60 minutes.</description>
      <arm_group_label>Peer Support Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age &gt;18 years&#xD;
  &#xD;
            -  New ischemic DFU &lt;6 months&#xD;
  &#xD;
            -  English or Spanish speaking&#xD;
  &#xD;
            -  Able to provide consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  incarceration or institutionalization&#xD;
  &#xD;
            -  unwillingness to participate in the PAI program&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Emily Rosario, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Casa Colina Hospital and Centers for Healthcare</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Niko Fullmer</last_name>
      <phone>909-596-7733</phone>
      <phone_ext>2220</phone_ext>
      <email>nfullmer@casacolina.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Rancho Los Amigos National Rehabilitation Center</name>
        <address>
          <city>Downey</city>
          <state>California</state>
          <zip>90242</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Tze-Woei Tan, MD</last_name>
        <phone>323-442-6835</phone>
        <email>Tze-woei.tan@med.usc.edu</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>University of Southern California</name>
        <address>
          <city>Los Angeles</city>
          <state>California</state>
          <zip>90033</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Tze-Woei Tan, MD</last_name>
        <phone>323-442-6835</phone>
        <email>Tze-woei.tan@med.usc.edu</email>
      </contact>
      <investigator>
        <last_name>Tze-Woei Tan</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Casa Colina Healthcare and Hospital</name>
        <address>
          <city>Pomona</city>
          <state>California</state>
          <zip>91767</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Emily Rosario, PhD</last_name>
        <phone>909-596-7733</phone>
        <phone_ext>3036</phone_ext>
        <email>erosario@casacolina.org</email>
      </contact>
      <investigator>
        <last_name>Emily Rosario, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <results_reference>
      <citation>Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375. doi: 10.1056/NEJMra1615439. No abstract available.</citation>
      <PMID>28614678</PMID>
    </results_reference>
    <results_reference>
      <citation>Hoffstad O, Mitra N, Walsh J, Margolis DJ. Diabetes, lower-extremity amputation, and death. Diabetes Care. 2015 Oct;38(10):1852-7. doi: 10.2337/dc15-0536. Epub 2015 Jul 22.</citation>
      <PMID>26203063</PMID>
    </results_reference>
    <results_reference>
      <citation>Crocker RM, Palmer KNB, Marrero DG, Tan TW. Patient perspectives on the physical, psycho-social, and financial impacts of diabetic foot ulceration and amputation. J Diabetes Complications. 2021 Aug;35(8):107960. doi: 10.1016/j.jdiacomp.2021.107960. Epub 2021 May 23.</citation>
      <PMID>34059410</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Casa Colina Hospital and Centers for Healthcare</investigator_affiliation>
      <investigator_full_name>Emily Rosario</investigator_full_name>
      <investigator_title>Executive Director</investigator_title>
    </responsible_party>
    <keyword>numbness</keyword>
    <keyword>tingling</keyword>
    <keyword>muscle weakness</keyword>
    <keyword>loss of balance</keyword>
    <keyword>shooting pain</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Peripheral Nervous System Diseases</mesh_term>
      <mesh_term>Diabetic Foot</mesh_term>
      <mesh_term>Foot Ulcer</mesh_term>
      <mesh_term>Diabetes Mellitus</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
      <mesh_term>Diabetes Complications</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06004219
  org study id: IRB:00002372
  nct id: NCT06004219
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective of the study is to develop a peer support program that helps improve ulcer care
        in patients with a diabetic foot ulcer (DFU).Diabetes, peripheral arterial disease (PAD),
        foot ulceration, and subsequent amputation are unevenly patterned in terms of
        racial/ethnicity, socioeconomic status, health insurance, and geographic area. The project
        will identify opportunities to reduce health disparities among economically marginalized
        patients regarding DFU outcomes.
  Of the estimated 30 million people in the U.S. with diabetes, 34% will develop a DFU in their
        lifetime, and 50% of those with a DFU have concurrent PAD. Foot ulceration, which precedes
        80% of amputations in diabetics, is associated with impaired physical function, reduced
        quality of life, and increased risk of death. Moreover, PAD, DFU, and subsequent major
        amputations are unevenly patterned in terms of racial/ethnic, SES, health insurance, and
        geographic status. More specifically, Black and Hispanic adults with an ischemic DFU have a
        higher prevalence of amputation than their White counterparts. The mechanisms of these
        observed disparities in amputation, beyond disease severity and comorbidities, are complex.
        However, evidence indicates that ulcer care (including wound care, diabetic shoe, offloading,
        and recognizing warning signs) is a significant challenge for low-income patients with an
        ischemic DFU. In addition, our team and other researchers have demonstrated how
        psychological, interpersonal, social, and healthcare system-level barriers limit appropriate
        ulcer and foot care. Furthermore, our qualitative data demonstrates a high rate of
        psychological and interpersonal factors to diabetic foot care that cannot be ignored.
        Clearly, there is a compelling need for innovative methods to improve DFU care that are based
        on health equity that led to diverse support. To address this gap, we propose a
        patient-centered and culturally tailored Peer-Pal Intervention (PPI) that helps promote ulcer
        care in patients with a DFU, while minimizing the burden placed on system resources.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: We will assign 12 patients into peer support group (intervention) and 12 patients as control (usual care with no support group) group. Patients will be followed for 6 months.
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: VascuQoL-6
  time frame: Complete at enrollment visit
  description: A self-reported survey or questionnaire that facilitates health-related quality of life assessment in peripheral arterial disease. Each question is scored 1-4. The sum of each individual question is used to generate a "Total" Quality of Life Score. A higher value indicates better health status.
  measure: VascuQoL-6
  time frame: Complete at 3 month visit
  description: A self-reported survey or questionnaire that facilitates health-related quality of life assessment in peripheral arterial disease. Each question is scored 1-4. The sum of each individual question is used to generate a "Total" Quality of Life Score. A higher value indicates better health status.
  measure: VascuQoL-6
  time frame: Complete at 6 month visit, end of study
  description: A self-reported survey or questionnaire that facilitates health-related quality of life assessment in peripheral arterial disease. Each question is scored 1-4. The sum of each individual question is used to generate a "Total" Quality of Life Score. A higher value indicates better health status.
  measure: PROMIS (Patient Reported Outcomes Measurement Information System)
  time frame: Complete at enrollment visit
  description: Set of person-centered measures which evaluates and monitors physical, mental and social health in adults. It will be administered using a computer adaptive test (CAT) where items are selected for administration from an item bank based upon the respondent's answers. Items are ordered by level of difficulty from low to high using the Item Response Theory. After a person provides a response, the estimated score is recalculated. The CAT continues to administer items until stopping rules are met. The stopping rules for adults are as follows: at least 4 items administered, 12-items are administered or the standard error is below a threshold (0.3 on the theta metric or 3.0 on the T-score metric).
  measure: PROMIS (Patient Reported Outcomes Measurement Information System)
  time frame: Complete at 3 month visit
  description: Set of person-centered measures which evaluates and monitors physical, mental and social health in adults. It will be administered using a computer adaptive test (CAT) where items are selected for administration from an item bank based upon the respondent's answers. Items are ordered by level of difficulty from low to high using the Item Response Theory. After a person provides a response, the estimated score is recalculated. The CAT continues to administer items until stopping rules are met. The stopping rules for adults are as follows: at least 4 items administered, 12-items are administered or the standard error is below a threshold (0.3 on the theta metric or 3.0 on the T-score metric).
  measure: PROMIS (Patient Reported Outcomes Measurement Information System)
  time frame: Complete at 6 month visit, end of study
  description: Set of person-centered measures which evaluates and monitors physical, mental and social health in adults. It will be administered using a computer adaptive test (CAT) where items are selected for administration from an item bank based upon the respondent's answers. Items are ordered by level of difficulty from low to high using the Item Response Theory. After a person provides a response, the estimated score is recalculated. The CAT continues to administer items until stopping rules are met. The stopping rules for adults are as follows: at least 4 items administered, 12-items are administered or the standard error is below a threshold (0.3 on the theta metric or 3.0 on the T-score metric).
  measure: Acceptability Questionnaire --Peer to Pal Intervention (PPI)
  time frame: End of study, 6 month visit
  description: 5-point scale: strongly agree, agree, neutral, disagree, and strongly disagree
  measure: Twenty Three Item Questionnaire (Heisler)
  time frame: End of Study, 6 month visit
  description: The questionnaire is a follow-up patient assessment comprised of 23 questions derived and modified from (Heisler et al.) It is a series of open ended questions to evaluate the effectiveness and attitudes of peer support with participants who have diabetic foot ulcer.
  measure: Diabetes Distress Screening Scale (DDS17)
  time frame: Complete at enrollment visit
  description: 6-point scale: 1-not a problem, 2-slight problem, 3- moderate problem, 4-somewhat serious problem, 5-serious problem, 6-very serious problem. A mean item score of 3 or higher indicates a level of distress worthy of clinical attention.
  measure: Diabetes Distress Screening Scale (DDS17)
  time frame: Complete at 3 month visit
  description: 6-point scale: 1-not a problem, 2-slight problem, 3- moderate problem, 4-somewhat serious problem, 5-serious problem, 6-very serious problem. A mean item score of 3 or higher indicates a level of distress worthy of clinical attention.
  measure: Diabetes Distress Screening Scale (DDS17)
  time frame: End of study, 6 month visit
  description: 6-point scale: 1-not a problem, 2-slight problem, 3- moderate problem, 4-somewhat serious problem, 5-serious problem, 6-very serious problem. A mean item score of 3 or higher indicates a level of distress worthy of clinical attention.
  arm group label: Peer Support Group
  arm group type: Experimental
  description: Patients will be asked to complete a health-related quality of life (HRQOL) survey at enrollment, 3 months, and end of the study. Participants will complete the VascuQoL-6 and PROMIS in several domains of HRQOL (including global physical function, global mental function, fatigue, depression, sleep disturbance, pain behavior, and social satisfaction). Each participant will complete the PROMIS CAT tool on an iPad App and the data will be stored in the secure REDCap
  arm group label: Usual Care Group
  arm group type: No Intervention
  description: Subjects in this group will not participate in the peer group.
  intervention type: Behavioral
  intervention name: Peer counseling group
  description: A community advisory board (CAB) will be set up for need assessment and to design the peer support program. Virtual meetings will be held quarterly for year 1 and 2. The group will consist of (up to 12 members) and will include at least 2 patient partners (patients with a recently diagnosed ulcer), 2 peer pals (patients with a healed DFU), family members or caregivers (limited to only 1 person per family represented on the CAB), healthcare workers (podiatrist, nurse, or case manager), medical equipment company representatives, and others. We will ask them about potential barriers at the first meeting, have flexible meeting times, and intentionally limit the number of healthcare providers. At the last meeting, we will seek feedback and input from the CAB. In addition, this group will have the opportunity to participate in a focus group which will be moderated with a trained, bilingual assistant and will last 40-60 minutes.
  arm group label: Peer Support Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Emily Rosario, PhD
  role: Principal Investigator
  affiliation: Casa Colina Hospital and Centers for Healthcare
  last name: Niko Fullmer
  phone: 909-596-7733
  phone ext: 2220
  email: nfullmer@casacolina.org
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  citation: Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375. doi: 10.1056/NEJMra1615439. No abstract available.
  PMID: 28614678
  citation: Hoffstad O, Mitra N, Walsh J, Margolis DJ. Diabetes, lower-extremity amputation, and death. Diabetes Care. 2015 Oct;38(10):1852-7. doi: 10.2337/dc15-0536. Epub 2015 Jul 22.
  PMID: 26203063
  citation: Crocker RM, Palmer KNB, Marrero DG, Tan TW. Patient perspectives on the physical, psycho-social, and financial impacts of diabetic foot ulceration and amputation. J Diabetes Complications. 2021 Aug;35(8):107960. doi: 10.1016/j.jdiacomp.2021.107960. Epub 2021 May 23.
  PMID: 34059410
  responsible party type: Principal Investigator
  investigator affiliation: Casa Colina Hospital and Centers for Healthcare
  investigator full name: Emily Rosario
  investigator title: Executive Director
  mesh term: Peripheral Nervous System Diseases
  mesh term: Diabetic Foot
  mesh term: Foot Ulcer
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2
  mesh term: Diabetes Complications
  sharing ipd: No