<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/NCT03293914</url>
  </required_header>
  <id_info>
    <org_study_id>SC CTSI Grant #UL1TR001855</org_study_id>
    <secondary_id>UL1TR001855</secondary_id>
    <nct_id>NCT03293914</nct_id>
  </id_info>
  <brief_title>Addressing Uncontrolled Diabetes in Primary Care: A Lifestyle Redesign Approach</brief_title>
  <official_title>Addressing Uncontrolled Diabetes in Primary Care: A Lifestyle Redesign Approach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Los Angeles County Department of Health Services (DHS)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Center for Advancing Translational Sciences (NCATS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</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>
      This study is examining the feasibility of implementing an occupational therapy intervention&#xD;
      addressing diabetes management in a primary care clinic within the Los Angeles County&#xD;
      Department of Health Services (LAC-DHS), as well as the impact of this intervention approach&#xD;
      on clinical outcomes, efficiency and patient-centeredness of care. This implementation&#xD;
      science study is evaluating two emerging trends in healthcare delivery: (1) the integration&#xD;
      of nontraditional providers into primary care medical home (PCMH) settings to facilitate the&#xD;
      delivery of high-quality, comprehensive primary care while reducing the burden on physicians;&#xD;
      and (2) the potential value of using occupational therapists to address chronic disease&#xD;
      management in this setting&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 18, 2017</start_date>
  <completion_date type="Actual">November 30, 2019</completion_date>
  <primary_completion_date type="Actual">May 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>This is an implementation trial being conducted in a real-world clinical setting in which masking is not appropriate.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in the daily rate of change of Glycated hemoglobin (HbA1C) during the year prior to baseline, compared to the period from baseline to post-intervention</measure>
    <time_frame>all measures taken from one year prior to baseline, to immediately post-intervention (an average of 4 months)</time_frame>
    <description>Measure of average blood glucose concentration over approximately the previous 12 weeks. HbA1C is measured periodically, as prescribed by study-independent provider.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Audit of Diabetes-Dependent Quality of Life (ADD-QoL) at post-intervention</measure>
    <time_frame>Baseline, an average of 4 months</time_frame>
    <description>19-item survey measure assessing impact of diabetes on social, physical, and emotional functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the daily rate of change of Patient Health Questionnaire-9 (PHQ-9) during the year prior to baseline, compared to the period from baseline to post-intervention</measure>
    <time_frame>all measures taken from one year prior to baseline, to immediately post-intervention (an average of 4 months)</time_frame>
    <description>9-item survey measure assessing severity of depressive symptoms. PHQ-9 is measured at each study-independent clinic visit for patients who screen positive on the PHQ-2 (score &gt;2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Summary of Diabetes Self-Care Activities (SDSCA) at post-intervention</measure>
    <time_frame>Baseline, an average of 4 months</time_frame>
    <description>14 items assessing diet, physical activity, medication adherence and other self-care behaviors relevant to diabetes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Medication adherence scale at post-intervention</measure>
    <time_frame>Baseline, an average of 4 months</time_frame>
    <description>3-item self-report medication adherence scale designed by Ira B. Wilson, Yoojin Lee, Joanne Michaud, Floyd J. FowlerJr., and William H. Rogers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Appraisal of Diabetes Scale at post-intervention</measure>
    <time_frame>Baseline, an average of 4 months</time_frame>
    <description>7-item self-report scale assessing the individual's appraisal of his or her diabetes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline RAND 20-Item Short Form Survey (SF-20) at post-intervention</measure>
    <time_frame>Baseline, an average of 4 months</time_frame>
    <description>The SF-20 is a 20-item set of generic, coherent, and easily administered quality-of-life measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability</measure>
    <time_frame>Months 11-12</time_frame>
    <description>Both formative and summative data will be gathered throughout the study to assess acceptability, defined herein as the perception of the intervention as agreeable/satisfactory. Acceptability will be assessed through interviews.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Appropriateness</measure>
    <time_frame>Months 0-2, 3-10, and 11-12</time_frame>
    <description>Both formative and summative data will be gathered throughout the study to assess appropriateness, defined herein as the perceived relevance or compatibility of the intervention in the practice setting. Appropriateness will be assessed through interviews.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility</measure>
    <time_frame>Months 0-2, and 11-12</time_frame>
    <description>Both formative and summative data will be gathered throughout the study to assess feasibility, defined herein as the extent to which the intervention can be successfully used in a practice setting. Feasibility will be assessed through surveys.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fidelity</measure>
    <time_frame>Months 0-2, 3-10, and 11-12</time_frame>
    <description>Both formative and summative data will be gathered throughout the study to assess fidelity, defined herein as the extent to which the intervention is implemented as intended. Fidelity will be assessed through score on fidelity checklist.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficiency</measure>
    <time_frame>Months 0-2 and 11-12</time_frame>
    <description>Both formative and summative data will be gathered throughout the study to assess efficiency, defined herein as the degree to which providers work to the &quot;top of license&quot;. Efficiency will be assessed through interviews.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timeliness</measure>
    <time_frame>Months 11-12</time_frame>
    <description>Both formative and summative data will be gathered throughout the study to assess timeliness, defined herein as the availability of appointments when needed. Timeliness will be assessed through staff documentation records.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">143</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be invited to enroll in an occupational therapy (OT) lifestyle redesign intervention focused on diabetes management. The intervention includes approximately 8 one-hour OT sessions over 4 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will not be contacted; outcome data will be extracted from medical records.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lifestyle Redesign</intervention_name>
    <description>Individualized lifestyle intervention incorporating the following topics: Diabetes knowledge; access to healthcare; communication with healthcare providers; incorporation of diabetes self-care tasks within daily habits and routines; social support; and emotional well-being. Participants receive approximately 8 hours of intervention by a licensed occupational therapist with training in diabetes education, motivational interviewing and the intervention protocol.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Resilient, Empowered, Active Living with Diabetes (REAL)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current patient at Los Angeles County-USC Medical Center Adult West Primary Care&#xD;
             clinic&#xD;
&#xD;
          -  Diagnosed diabetes (type 1 or type 2) documented in EMR&#xD;
&#xD;
          -  Most recent HbA1c level &gt;9.0% OR has not had an HbA1c measurement within past 12&#xD;
             months&#xD;
&#xD;
          -  Per provider judgment, would be willing to make lifestyle changes related to diabetes&#xD;
             self-care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active, untreated substance use or behavioral health disorder which interferes with&#xD;
             participation in major life activities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth Pyatak, PhD, OTR/L</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>LAC+USC Primary Care Adult West Clinic</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://chan.usc.edu/research/funded/uncontrolled-diabetes</url>
    <description>Summary of research study.</description>
  </link>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>March 23, 2020</last_update_submitted>
  <last_update_submitted_qc>March 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>Beth Pyatak</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03293914
org study id: SC CTSI Grant #UL1TR001855
secondary id: UL1TR001855
nct id: NCT03293914
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is examining the feasibility of implementing an occupational therapy intervention
      addressing diabetes management in a primary care clinic within the Los Angeles County
      Department of Health Services (LAC-DHS), as well as the impact of this intervention approach
      on clinical outcomes, efficiency and patient-centeredness of care. This implementation
      science study is evaluating two emerging trends in healthcare delivery: (1) the integration
      of nontraditional providers into primary care medical home (PCMH) settings to facilitate the
      delivery of high-quality, comprehensive primary care while reducing the burden on physicians;
      and (2) the potential value of using occupational therapists to address chronic disease
      management in this setting
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: This is an implementation trial being conducted in a real-world clinical setting in which masking is not appropriate.
measure: Difference in the daily rate of change of Glycated hemoglobin (HbA1C) during the year prior to baseline, compared to the period from baseline to post-intervention
time frame: all measures taken from one year prior to baseline, to immediately post-intervention (an average of 4 months)
description: Measure of average blood glucose concentration over approximately the previous 12 weeks. HbA1C is measured periodically, as prescribed by study-independent provider.
measure: Change from baseline in Audit of Diabetes-Dependent Quality of Life (ADD-QoL) at post-intervention
time frame: Baseline, an average of 4 months
description: 19-item survey measure assessing impact of diabetes on social, physical, and emotional functioning.
measure: Difference in the daily rate of change of Patient Health Questionnaire-9 (PHQ-9) during the year prior to baseline, compared to the period from baseline to post-intervention
time frame: all measures taken from one year prior to baseline, to immediately post-intervention (an average of 4 months)
description: 9-item survey measure assessing severity of depressive symptoms. PHQ-9 is measured at each study-independent clinic visit for patients who screen positive on the PHQ-2 (score >2).
measure: Change from baseline in Summary of Diabetes Self-Care Activities (SDSCA) at post-intervention
time frame: Baseline, an average of 4 months
description: 14 items assessing diet, physical activity, medication adherence and other self-care behaviors relevant to diabetes.
measure: Change from baseline in Medication adherence scale at post-intervention
time frame: Baseline, an average of 4 months
description: 3-item self-report medication adherence scale designed by Ira B. Wilson, Yoojin Lee, Joanne Michaud, Floyd J. FowlerJr., and William H. Rogers
measure: Change from baseline in Appraisal of Diabetes Scale at post-intervention
time frame: Baseline, an average of 4 months
description: 7-item self-report scale assessing the individual's appraisal of his or her diabetes
measure: Change from baseline RAND 20-Item Short Form Survey (SF-20) at post-intervention
time frame: Baseline, an average of 4 months
description: The SF-20 is a 20-item set of generic, coherent, and easily administered quality-of-life measures.
measure: Acceptability
time frame: Months 11-12
description: Both formative and summative data will be gathered throughout the study to assess acceptability, defined herein as the perception of the intervention as agreeable/satisfactory. Acceptability will be assessed through interviews.
measure: Appropriateness
time frame: Months 0-2, 3-10, and 11-12
description: Both formative and summative data will be gathered throughout the study to assess appropriateness, defined herein as the perceived relevance or compatibility of the intervention in the practice setting. Appropriateness will be assessed through interviews.
measure: Feasibility
time frame: Months 0-2, and 11-12
description: Both formative and summative data will be gathered throughout the study to assess feasibility, defined herein as the extent to which the intervention can be successfully used in a practice setting. Feasibility will be assessed through surveys.
measure: Fidelity
time frame: Months 0-2, 3-10, and 11-12
description: Both formative and summative data will be gathered throughout the study to assess fidelity, defined herein as the extent to which the intervention is implemented as intended. Fidelity will be assessed through score on fidelity checklist.
measure: Efficiency
time frame: Months 0-2 and 11-12
description: Both formative and summative data will be gathered throughout the study to assess efficiency, defined herein as the degree to which providers work to the "top of license". Efficiency will be assessed through interviews.
measure: Timeliness
time frame: Months 11-12
description: Both formative and summative data will be gathered throughout the study to assess timeliness, defined herein as the availability of appointments when needed. Timeliness will be assessed through staff documentation records.
arm group label: Intervention
arm group type: Experimental
description: Participants will be invited to enroll in an occupational therapy (OT) lifestyle redesign intervention focused on diabetes management. The intervention includes approximately 8 one-hour OT sessions over 4 months.
arm group label: Usual Care Control
arm group type: No Intervention
description: Participants will not be contacted; outcome data will be extracted from medical records.
intervention type: Behavioral
intervention name: Lifestyle Redesign
description: Individualized lifestyle intervention incorporating the following topics: Diabetes knowledge; access to healthcare; communication with healthcare providers; incorporation of diabetes self-care tasks within daily habits and routines; social support; and emotional well-being. Participants receive approximately 8 hours of intervention by a licensed occupational therapist with training in diabetes education, motivational interviewing and the intervention protocol.
arm group label: Intervention
other name: Resilient, Empowered, Active Living with Diabetes (REAL)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Elizabeth Pyatak, PhD, OTR/L
role: Principal Investigator
affiliation: University of Southern California
facility: 
country: United States
url: http://chan.usc.edu/research/funded/uncontrolled-diabetes
description: Summary of research study.
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: Beth Pyatak
investigator title: Assistant Professor
mesh term: Diabetes Mellitus
sharing ipd: No