<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/NCT03812614</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY20110344</org_study_id>
    <secondary_id>R01DK116733</secondary_id>
    <nct_id>NCT03812614</nct_id>
  </id_info>
  <brief_title>Comparative Effectiveness of Family vs. Individually Focused Diabetes Education and Support</brief_title>
  <official_title>Comparative Effectiveness of Adding Family Supporter Training to a CHW-Led Intervention to Improve Behavioral Management of Multiple Risk Factors for Diabetes Complications</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Community Health and Social Services Center, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>Yes</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 this study is to compare the effectiveness of a novel program-Family Support&#xD;
      for Health Action (FAM-ACT) - to individual patient-focused diabetes self-management&#xD;
      education and support (I-DSMES).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      FAM-ACT uses three innovative approaches to enhance the impact of family support on diabetes&#xD;
      management for adults with diabetes (AWDs):&#xD;
&#xD;
        1. coach family supporters in regular discussions about AWDs' diabetes progress and goals&#xD;
           that uses empathetic and autonomy-supportive communication,&#xD;
&#xD;
        2. coach family supporters in practical roles that support diabetes-specific tasks tailored&#xD;
           to AWDs' personal goals,&#xD;
&#xD;
        3. leverage family support in the setting of other types of social support for AWDs&#xD;
           (support from other AWDs and their family members and Community Health Workers (CHWs))&#xD;
&#xD;
      FAM-ACT will be developed and implemented in culturally-concordant ways, in partnership with&#xD;
      the community participating in the program.&#xD;
&#xD;
      Adults with type 2 diabetes and either poor glycemic or blood pressure control will be&#xD;
      randomized together with a Support Person (a chosen adult family member or friend) to receive&#xD;
      either FAM-ACT or more traditional CHW-led patient-focused I-DSMES over 6 months.&#xD;
&#xD;
      See our published protocol (Deverts et al 2022; full citation in references section) for&#xD;
      additional details on the protocol including any changes made after the study started.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 23, 2019</start_date>
  <completion_date type="Anticipated">May 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>
    <intervention_model_description>This is a randomized comparative effectiveness trial comparing two interventions.&#xD;
The participants and staff delivering the interventions will not be blinded, but the data analyst will be.&#xD;
This trial aims to compare the effect of the FAM-ACT intervention on patients' diabetes-related health behaviors and outcomes compared to patient-focused DSME and support (I-DSMES).</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Outcomes Assessor will be unaware of the arm assignment of the participant when assessing main outcomes.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in patient glycemic control at 6 months</measure>
    <time_frame>Baseline vs. 6 months</time_frame>
    <description>Hemoglobin A1c (HbA1c) in % will be measured through finger stick performed by a study RA, by a clinician as a part of the patients' regular care, or by the patients themselves via a home test kit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in patient glycemic control at 12 months</measure>
    <time_frame>Baseline vs. 12 months</time_frame>
    <description>Hemoglobin A1c (HbA1c) in % will be measured through finger stick performed by a study RA, by a clinician as a part of the patients' regular care, or by the patients themselves via a home test kit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in systolic blood pressure</measure>
    <time_frame>Baseline vs. 6 months</time_frame>
    <description>SBP will be measured using an electronic, upper arm blood pressure monitor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in systolic blood pressure</measure>
    <time_frame>Baseline vs. 12 months</time_frame>
    <description>SBP will be measured using an electronic, upper arm blood pressure monitor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in diabetes distress in patient</measure>
    <time_frame>Baseline vs. 6 months</time_frame>
    <description>Patient diabetes distress will be assessed using the Problem Areas in Diabetes (PAID-5) Scale. The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items will be summed to create a total score with a range of 0 to 20. A total score of &gt;=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in diabetes distress in patient</measure>
    <time_frame>Baseline vs. 12 months</time_frame>
    <description>Patient diabetes distress will be assessed using the Problem Areas in Diabetes (PAID-5) Scale. The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items will be summed to create a total score with a range of 0 to 20. A total score of &gt;=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in diabetes self-care behaviors in patient: Healthy Eating</measure>
    <time_frame>Baseline vs. 6 months</time_frame>
    <description>The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Our study will score results within each domain separately.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in diabetes self-care behaviors in patient: Physical Activity</measure>
    <time_frame>Baseline vs. 6 months</time_frame>
    <description>The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Our study will score results within each domain separately.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in diabetes self-care behaviors in patient: Medication Adherence</measure>
    <time_frame>Baseline vs. 6 months</time_frame>
    <description>The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Our study will score results within each domain separately.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-efficacy of patient</measure>
    <time_frame>Baseline vs. 6 months</time_frame>
    <description>Patient self-efficacy for managing diabetes will be assessed with the Self-Efficacy for Managing Chronic Diseases Scale. The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can perform tasks related to their diabetes management. Responses range from 0 to 10, with higher numbers indicating greater self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in patient activation in patient</measure>
    <time_frame>Baseline vs. 6 months</time_frame>
    <description>Patient activation will be assessed with the Patient Activation Measure (PAM)-10. Using a 4-point scale (1=strongly disagree to 4=strongly agree), respondents indicate the extent to which statements related to being ready, willing and able to manage their health and health care accurately describe them. Responses are summed to create a total score with higher numbers indicating greater activation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient perceived overall satisfaction with SP support for diabetes</measure>
    <time_frame>Baseline vs. 6 months</time_frame>
    <description>Patient satisfaction with SP support for diabetes will be assessed with o items assessing patient's satisfaction with the support they receive from their SP and whether they feel like they would be worse off without their SP's help with their diabetes care. Responses will be rated on a 7-point scale ranging from &quot;strongly disagree&quot; to &quot;strongly agree&quot;. Responses are summed to create a total score with higher numbers indicating greater satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient perception of SP support: Supportive and non-supportive behaviors</measure>
    <time_frame>Baseline vs. 6 months</time_frame>
    <description>Patient perception of SP's supportive behaviors will be assessed using the 8-item Important Other Climate Questionnaire (IOCQ) and non-supportive behaviors using 3 similarly-structured items addressing SP irritation, criticism and argumentativeness. All items are rated on a 7-point scale ranging from 1 (&quot;strongly disagree&quot;) to 7 (&quot;strongly agree&quot;), with non-supportive behavior items being reversed scored.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of COVID on ability to manage diabetes</measure>
    <time_frame>Cross-sectional at 6 months</time_frame>
    <description>Impact of COVID on Ability to Manage Diabetes will be assessed with a single closed-ended item: &quot;In the last six months, how have the COVID pandemic or social distancing rules affected your ability to manage your diabetes?&quot; The item is rated on a 5-point scale ranging from &quot;much harder&quot; to &quot;much easier&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in diabetes distress in support person</measure>
    <time_frame>Baseline vs. 6 months</time_frame>
    <description>Support person distress about the patient's diabetes will be assessed using the Problem Areas in Diabetes (PAID-5) Scale (for family members). The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items will be summed to create a total score with a range of 0 to 20. A total score of &gt;=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in self-efficacy of support person</measure>
    <time_frame>Baseline vs. 6 months</time_frame>
    <description>Support person self-efficacy for helping the patient with managing diabetes will be assessed with the Self-Efficacy for Managing Chronic Diseases Scale (adapted for support persons). The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can help patients perform tasks related to their diabetes management. Responses range from 0 to 10, with higher numbers indicating greater self-efficacy.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in diabetes self-care behaviors in patient: Healthy Eating</measure>
    <time_frame>Baseline vs. 12 months</time_frame>
    <description>The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Our study will score results within each domain separately.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in diabetes self-care behaviors in patient: Physical Activity</measure>
    <time_frame>Baseline vs. 12 months</time_frame>
    <description>The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Our study will score results within each domain separately.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in diabetes self-care behaviors in patient: Medication Adherence</measure>
    <time_frame>Baseline vs. 12 months</time_frame>
    <description>The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Our study will score results within each domain separately.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in self-efficacy of patient</measure>
    <time_frame>Baseline vs. 12 months</time_frame>
    <description>Patient self-efficacy for managing diabetes will be assessed with the Self-Efficacy for Managing Chronic Diseases Scale. The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can perform tasks related to their diabetes management. Responses range from 0 to 10, with higher numbers indicating greater self-efficacy.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in patient activation in patient</measure>
    <time_frame>Baseline vs. 12 months</time_frame>
    <description>Patient activation will be assessed with the Patient Activation Measure (PAM)-10. Using a 4-point scale (1=strongly disagree to 4=strongly agree), respondents indicate the extent to which statements related to being ready, willing and able to manage their health and health care accurately describe them. Responses are summed to create a total score with higher numbers indicating greater activation.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient perceived overall satisfaction with SP support for diabetes</measure>
    <time_frame>Baseline vs. 12 months</time_frame>
    <description>Patient satisfaction with SP support for diabetes will be assessed with o items assessing patient's satisfaction with the support they receive from their SP and whether they feel like they would be worse off without their SP's help with their diabetes care. Responses will be rated on a 7-point scale ranging from &quot;strongly disagree&quot; to &quot;strongly agree&quot;. Responses are summed to create a total score with higher numbers indicating greater satisfaction.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient perception of SP support: Supportive and non-supportive behaviors</measure>
    <time_frame>Baseline vs. 12 months</time_frame>
    <description>Patient perception of SP's supportive behaviors will be assessed using the 8-item Important Other Climate Questionnaire (IOCQ) and non-supportive behaviors using 3 similarly-structured items addressing SP irritation, criticism and argumentativeness. All items are rated on a 7-point scale ranging from 1 (&quot;strongly disagree&quot;) to 7 (&quot;strongly agree&quot;), with non-supportive behavior items being reversed scored.</description>
  </other_outcome>
  <other_outcome>
    <measure>Impact of COVID on ability to manage diabetes</measure>
    <time_frame>Cross-sectional at 12 months</time_frame>
    <description>Impact of COVID on Ability to Manage Diabetes will be assessed with a single closed-ended item: &quot;In the last six months, how have the COVID pandemic or social distancing rules affected your ability to manage your diabetes?&quot; The item is rated on a 5-point scale ranging from &quot;much harder&quot; to &quot;much easier&quot;.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in diabetes distress in support person</measure>
    <time_frame>Baseline vs. 12 months</time_frame>
    <description>Support person distress about the patient's diabetes will be assessed using the Problem Areas in Diabetes (PAID-5) Scale (for family members). The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items will be summed to create a total score with a range of 0 to 20. A total score of &gt;=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in self-efficacy of support person</measure>
    <time_frame>Baseline vs. 12 months</time_frame>
    <description>Support person self-efficacy for helping the patient with managing diabetes will be assessed with the Self-Efficacy for Managing Chronic Diseases Scale (adapted for support persons). The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can help patients perform tasks related to their diabetes management. Responses range from 0 to 10, with higher numbers indicating greater self-efficacy.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">444</enrollment>
  <condition>Diabetes Mellitus</condition>
  <condition>High Blood Pressure</condition>
  <condition>High Blood Sugar</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>FAM-ACT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient and Support Person (dyad) will be included together as much as possible. The dyad will:&#xD;
Take part in a one-hour introductory session and review of the patient's Diabetes Complications Risk Assessment profile.&#xD;
Be invited to 4-6 Support Person-focused, group diabetes self-management education (DSME) sessions lasting 1-2 ½ hours each.&#xD;
Receive case management contacts with a Community Health Worker (CHW) once every 2-4 weeks, subject to participant availability. Successful contacts will last approximately 20 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>I-DSMES</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm will focus on the patient only. The Support Person assigned to this arm will not be invited to the introduction sessions, care management contacts, or diabetes self-management education sessions. Patients assigned to this arm will:&#xD;
Take part in a one-hour introductory session and review of patient's diabetes management risk assessment.&#xD;
Be invited to 4-6 group diabetes self-management education (DSME) sessions lasting 45 min to 2 hours each.&#xD;
Receive case management contacts with a Community Health Worker (CHW) once every 2-4 weeks, subject to participant availability. Successful contacts will last approximately 20 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>FAM ACT</intervention_name>
    <description>Patient and Support Person (dyad) will receive a Diabetes Complications Risk Assessment profile and introduction session, Support Person-focused information/skills training through 4-6 extended DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments.</description>
    <arm_group_label>FAM-ACT</arm_group_label>
    <other_name>Family Support for Health Action</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>I-DSMES</intervention_name>
    <description>Patient only will receive a Diabetes Complications Risk Assessment profile and introduction session, 4-6 group DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments.</description>
    <arm_group_label>I-DSMES</arm_group_label>
    <other_name>Individual-Focused DM Self-Management Education and Support</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Patient Inclusion Criteria:&#xD;
&#xD;
          1. Have a diagnosis of Type 2 diabetes&#xD;
&#xD;
          2. Most recent HbA1c done in the 3 months prior to screening phone call &gt;= 7.5%&#xD;
&#xD;
          3. Plan to use recruiting site for health care over the next 12 months after enrollment&#xD;
&#xD;
          4. Must be able to identify a family member or friend who is willing to be involved in&#xD;
             their health care&#xD;
&#xD;
        Patient Exclusion Criteria:&#xD;
&#xD;
          1. Diagnosis (active or prior) of Alzheimer's disease or dementia&#xD;
&#xD;
          2. Preferred language is not English or Spanish&#xD;
&#xD;
          3. Diagnosis (active or prior) of schizophrenia or other psychotic/delusional disorder in&#xD;
             CHASS EMR Problem list as of screening call date&#xD;
&#xD;
          4. Diagnosis of gestational diabetes without any other diabetes diagnoses&#xD;
&#xD;
          5. Diagnosed with diabetes at age &lt; 21 years&#xD;
&#xD;
          6. Pregnant or planning to become pregnant in the next 12 months&#xD;
&#xD;
          7. Concerns that may make it difficult to participate (ongoing health issues, personal&#xD;
             events, etc.)&#xD;
&#xD;
          8. Have a life-limiting severe illness (e.g. chronic obstructive pulmonary disease&#xD;
             requiring oxygen)&#xD;
&#xD;
        Support Person Inclusion Criteria:&#xD;
&#xD;
          1. Able to attend intervention sessions in person or remotely via online&#xD;
             video-conferencing&#xD;
&#xD;
          2. At least 21 years old&#xD;
&#xD;
        Support Person Exclusion Criteria:&#xD;
&#xD;
          1. Does not speak English or Spanish&#xD;
&#xD;
          2. Receives pay for caring for the patient&#xD;
&#xD;
          3. Has self-reported serious mental illness (schizophrenia)&#xD;
&#xD;
          4. Has a life-limiting severe illness (e.g. chronic obstructive pulmonary disease&#xD;
             requiring oxygen)&#xD;
&#xD;
          5. Has significant cognitive impairment (Alzheimer's disease or dementia)&#xD;
&#xD;
          6. Lives in a nursing home or long-term care facility&#xD;
&#xD;
          7. Concerns that may make it difficult to participate (ongoing health issues, personal&#xD;
             events, etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ann-Marie Rosland, MD,MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Community Health and Social Services Center (CHASS)</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Deverts DJ, Heisler M, Kieffer EC, Piatt GA, Valbuena F, Yabes JG, Guajardo C, Ilarraza-Montalvo D, Palmisano G, Koerbel G, Rosland AM. Comparing the effectiveness of Family Support for Health Action (FAM-ACT) with traditional community health worker-led interventions to improve adult diabetes management and outcomes: study protocol for a randomized controlled trial. Trials. 2022 Oct 3;23(1):841. doi: 10.1186/s13063-022-06764-1.</citation>
    <PMID>36192769</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>August 4, 2023</last_update_submitted>
  <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Ann-Marie Rosland</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <keyword>Patient Activation</keyword>
  <keyword>Self Management Education</keyword>
  <keyword>Self Management Behavior</keyword>
  <keyword>Autonomy Support</keyword>
  <keyword>Social Support</keyword>
  <keyword>Caregiver</keyword>
  <keyword>Family Support</keyword>
  <keyword>Glycemic Control</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Hyperglycemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The study investigators will make de-identified data sets available for sharing after the trial is finished and primary analyses have been completed and published. Researchers requesting data must present an IRB-approved methodological protocol and explain the relevance of their interest in the study completed data to public health goals. Authors completing secondary analyses of the shared study data must agree to the Center for Clinical Trials and Data Coordination (CCDC) policy on data sharing and publishing. All secondary analysis authors will be expected to credit the primary investigators and mention the data source in all publications. Secondary authors will acknowledge that the data use was in accordance with CCDC protocol and the signed Data Use Agreement (DUA). The University of Pittsburgh Principal Investigator and study coordinator will not release any data until all request criteria are met and a signed Data Use Agreement is filed.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>The data will become available beginning 6 months and ending 36 months after the primary trial results are published.</ipd_time_frame>
    <ipd_access_criteria>All access will be thru the Center for Clinical Trials &amp; Data Coordination (CCDC) at the University of Pittsburgh. Access will be monitored and controlled by our data center. No access will be granted until the initial requesting investigator vetting process is completed and a signed DUA is on file. All data safety plans and monitoring are listed on the CCDC website. Researchers interested in the data must sign a data use agreement (DUA) with the University of Pittsburgh, which must also be reviewed and agreed to by study partner CHASS Center Inc. No other data sharing options will be considered. The data that may be shared includes: de-identified participant data, tables, figures, appendices, analysis plan, and protocol.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 7, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03812614/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03812614
org study id: STUDY20110344
secondary id: R01DK116733
nct id: NCT03812614
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to compare the effectiveness of a novel program-Family Support
      for Health Action (FAM-ACT) - to individual patient-focused diabetes self-management
      education and support (I-DSMES).
FAM-ACT uses three innovative approaches to enhance the impact of family support on diabetes
      management for adults with diabetes (AWDs):

        1. coach family supporters in regular discussions about AWDs' diabetes progress and goals
           that uses empathetic and autonomy-supportive communication,

        2. coach family supporters in practical roles that support diabetes-specific tasks tailored
           to AWDs' personal goals,

        3. leverage family support in the setting of other types of social support for AWDs
           (support from other AWDs and their family members and Community Health Workers (CHWs))

      FAM-ACT will be developed and implemented in culturally-concordant ways, in partnership with
      the community participating in the program.

      Adults with type 2 diabetes and either poor glycemic or blood pressure control will be
      randomized together with a Support Person (a chosen adult family member or friend) to receive
      either FAM-ACT or more traditional CHW-led patient-focused I-DSMES over 6 months.

      See our published protocol (Deverts et al 2022; full citation in references section) for
      additional details on the protocol including any changes made after the study started.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a randomized comparative effectiveness trial comparing two interventions.
The participants and staff delivering the interventions will not be blinded, but the data analyst will be.
This trial aims to compare the effect of the FAM-ACT intervention on patients' diabetes-related health behaviors and outcomes compared to patient-focused DSME and support (I-DSMES).
primary purpose: Health Services Research
masking: Double (Investigator, Outcomes Assessor)
masking description: Outcomes Assessor will be unaware of the arm assignment of the participant when assessing main outcomes.
measure: Change from baseline in patient glycemic control at 6 months
time frame: Baseline vs. 6 months
description: Hemoglobin A1c (HbA1c) in % will be measured through finger stick performed by a study RA, by a clinician as a part of the patients' regular care, or by the patients themselves via a home test kit.
measure: Change from baseline in patient glycemic control at 12 months
time frame: Baseline vs. 12 months
description: Hemoglobin A1c (HbA1c) in % will be measured through finger stick performed by a study RA, by a clinician as a part of the patients' regular care, or by the patients themselves via a home test kit.
measure: Change in systolic blood pressure
time frame: Baseline vs. 6 months
description: SBP will be measured using an electronic, upper arm blood pressure monitor.
measure: Change in systolic blood pressure
time frame: Baseline vs. 12 months
description: SBP will be measured using an electronic, upper arm blood pressure monitor.
measure: Change in diabetes distress in patient
time frame: Baseline vs. 6 months
description: Patient diabetes distress will be assessed using the Problem Areas in Diabetes (PAID-5) Scale. The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items will be summed to create a total score with a range of 0 to 20. A total score of >=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress.
measure: Change in diabetes distress in patient
time frame: Baseline vs. 12 months
description: Patient diabetes distress will be assessed using the Problem Areas in Diabetes (PAID-5) Scale. The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items will be summed to create a total score with a range of 0 to 20. A total score of >=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress.
measure: Change in diabetes self-care behaviors in patient: Healthy Eating
time frame: Baseline vs. 6 months
description: The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Our study will score results within each domain separately.
measure: Change in diabetes self-care behaviors in patient: Physical Activity
time frame: Baseline vs. 6 months
description: The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Our study will score results within each domain separately.
measure: Change in diabetes self-care behaviors in patient: Medication Adherence
time frame: Baseline vs. 6 months
description: The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Our study will score results within each domain separately.
measure: Change in self-efficacy of patient
time frame: Baseline vs. 6 months
description: Patient self-efficacy for managing diabetes will be assessed with the Self-Efficacy for Managing Chronic Diseases Scale. The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can perform tasks related to their diabetes management. Responses range from 0 to 10, with higher numbers indicating greater self-efficacy.
measure: Change in patient activation in patient
time frame: Baseline vs. 6 months
description: Patient activation will be assessed with the Patient Activation Measure (PAM)-10. Using a 4-point scale (1=strongly disagree to 4=strongly agree), respondents indicate the extent to which statements related to being ready, willing and able to manage their health and health care accurately describe them. Responses are summed to create a total score with higher numbers indicating greater activation.
measure: Patient perceived overall satisfaction with SP support for diabetes
time frame: Baseline vs. 6 months
description: Patient satisfaction with SP support for diabetes will be assessed with o items assessing patient's satisfaction with the support they receive from their SP and whether they feel like they would be worse off without their SP's help with their diabetes care. Responses will be rated on a 7-point scale ranging from "strongly disagree" to "strongly agree". Responses are summed to create a total score with higher numbers indicating greater satisfaction.
measure: Patient perception of SP support: Supportive and non-supportive behaviors
time frame: Baseline vs. 6 months
description: Patient perception of SP's supportive behaviors will be assessed using the 8-item Important Other Climate Questionnaire (IOCQ) and non-supportive behaviors using 3 similarly-structured items addressing SP irritation, criticism and argumentativeness. All items are rated on a 7-point scale ranging from 1 ("strongly disagree") to 7 ("strongly agree"), with non-supportive behavior items being reversed scored.
measure: Impact of COVID on ability to manage diabetes
time frame: Cross-sectional at 6 months
description: Impact of COVID on Ability to Manage Diabetes will be assessed with a single closed-ended item: "In the last six months, how have the COVID pandemic or social distancing rules affected your ability to manage your diabetes?" The item is rated on a 5-point scale ranging from "much harder" to "much easier".
measure: Change in diabetes distress in support person
time frame: Baseline vs. 6 months
description: Support person distress about the patient's diabetes will be assessed using the Problem Areas in Diabetes (PAID-5) Scale (for family members). The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items will be summed to create a total score with a range of 0 to 20. A total score of >=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress.
measure: Change in self-efficacy of support person
time frame: Baseline vs. 6 months
description: Support person self-efficacy for helping the patient with managing diabetes will be assessed with the Self-Efficacy for Managing Chronic Diseases Scale (adapted for support persons). The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can help patients perform tasks related to their diabetes management. Responses range from 0 to 10, with higher numbers indicating greater self-efficacy.
measure: Change in diabetes self-care behaviors in patient: Healthy Eating
time frame: Baseline vs. 12 months
description: The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Our study will score results within each domain separately.
measure: Change in diabetes self-care behaviors in patient: Physical Activity
time frame: Baseline vs. 12 months
description: The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Our study will score results within each domain separately.
measure: Change in diabetes self-care behaviors in patient: Medication Adherence
time frame: Baseline vs. 12 months
description: The Summary of Diabetes Self-Care Activities (SDSCA) is a brief self-report instrument for measuring levels of self-management across different components of the diabetes regimen. Our study will score results within each domain separately.
measure: Change in self-efficacy of patient
time frame: Baseline vs. 12 months
description: Patient self-efficacy for managing diabetes will be assessed with the Self-Efficacy for Managing Chronic Diseases Scale. The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can perform tasks related to their diabetes management. Responses range from 0 to 10, with higher numbers indicating greater self-efficacy.
measure: Change in patient activation in patient
time frame: Baseline vs. 12 months
description: Patient activation will be assessed with the Patient Activation Measure (PAM)-10. Using a 4-point scale (1=strongly disagree to 4=strongly agree), respondents indicate the extent to which statements related to being ready, willing and able to manage their health and health care accurately describe them. Responses are summed to create a total score with higher numbers indicating greater activation.
measure: Patient perceived overall satisfaction with SP support for diabetes
time frame: Baseline vs. 12 months
description: Patient satisfaction with SP support for diabetes will be assessed with o items assessing patient's satisfaction with the support they receive from their SP and whether they feel like they would be worse off without their SP's help with their diabetes care. Responses will be rated on a 7-point scale ranging from "strongly disagree" to "strongly agree". Responses are summed to create a total score with higher numbers indicating greater satisfaction.
measure: Patient perception of SP support: Supportive and non-supportive behaviors
time frame: Baseline vs. 12 months
description: Patient perception of SP's supportive behaviors will be assessed using the 8-item Important Other Climate Questionnaire (IOCQ) and non-supportive behaviors using 3 similarly-structured items addressing SP irritation, criticism and argumentativeness. All items are rated on a 7-point scale ranging from 1 ("strongly disagree") to 7 ("strongly agree"), with non-supportive behavior items being reversed scored.
measure: Impact of COVID on ability to manage diabetes
time frame: Cross-sectional at 12 months
description: Impact of COVID on Ability to Manage Diabetes will be assessed with a single closed-ended item: "In the last six months, how have the COVID pandemic or social distancing rules affected your ability to manage your diabetes?" The item is rated on a 5-point scale ranging from "much harder" to "much easier".
measure: Change in diabetes distress in support person
time frame: Baseline vs. 12 months
description: Support person distress about the patient's diabetes will be assessed using the Problem Areas in Diabetes (PAID-5) Scale (for family members). The scale is comprised of 5 closed-ended items with response options ranging from 0 ('not a problem') to 4 ('serious problem'). The scale's 5 items will be summed to create a total score with a range of 0 to 20. A total score of >=8 indicates possible diabetes-related emotional distress that warrants further assessment, with higher scores suggesting greater diabetes-related emotional distress.
measure: Change in self-efficacy of support person
time frame: Baseline vs. 12 months
description: Support person self-efficacy for helping the patient with managing diabetes will be assessed with the Self-Efficacy for Managing Chronic Diseases Scale (adapted for support persons). The scale is comprised of 5 items asking respondents to indicate how confident they are that they regularly can help patients perform tasks related to their diabetes management. Responses range from 0 to 10, with higher numbers indicating greater self-efficacy.
arm group label: FAM-ACT
arm group type: Experimental
description: Patient and Support Person (dyad) will be included together as much as possible. The dyad will:
Take part in a one-hour introductory session and review of the patient's Diabetes Complications Risk Assessment profile.
Be invited to 4-6 Support Person-focused, group diabetes self-management education (DSME) sessions lasting 1-2 ½ hours each.
Receive case management contacts with a Community Health Worker (CHW) once every 2-4 weeks, subject to participant availability. Successful contacts will last approximately 20 minutes.
arm group label: I-DSMES
arm group type: Active Comparator
description: This arm will focus on the patient only. The Support Person assigned to this arm will not be invited to the introduction sessions, care management contacts, or diabetes self-management education sessions. Patients assigned to this arm will:
Take part in a one-hour introductory session and review of patient's diabetes management risk assessment.
Be invited to 4-6 group diabetes self-management education (DSME) sessions lasting 45 min to 2 hours each.
Receive case management contacts with a Community Health Worker (CHW) once every 2-4 weeks, subject to participant availability. Successful contacts will last approximately 20 minutes.
intervention type: Behavioral
intervention name: FAM ACT
description: Patient and Support Person (dyad) will receive a Diabetes Complications Risk Assessment profile and introduction session, Support Person-focused information/skills training through 4-6 extended DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments.
arm group label: FAM-ACT
other name: Family Support for Health Action
intervention type: Behavioral
intervention name: I-DSMES
description: Patient only will receive a Diabetes Complications Risk Assessment profile and introduction session, 4-6 group DSME sessions, case management contacts with CHW throughout the duration of the 6-month intervention, and guidance on how to prepare for and participate in healthcare appointments.
arm group label: I-DSMES
other name: Individual-Focused DM Self-Management Education and Support
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ann-Marie Rosland, MD,MS
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
facility: 
country: United States
citation: Deverts DJ, Heisler M, Kieffer EC, Piatt GA, Valbuena F, Yabes JG, Guajardo C, Ilarraza-Montalvo D, Palmisano G, Koerbel G, Rosland AM. Comparing the effectiveness of Family Support for Health Action (FAM-ACT) with traditional community health worker-led interventions to improve adult diabetes management and outcomes: study protocol for a randomized controlled trial. Trials. 2022 Oct 3;23(1):841. doi: 10.1186/s13063-022-06764-1.
PMID: 36192769
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Ann-Marie Rosland
investigator title: Associate Professor
mesh term: Hypertension
mesh term: Diabetes Mellitus
mesh term: Hyperglycemia
sharing ipd: Yes
ipd description: The study investigators will make de-identified data sets available for sharing after the trial is finished and primary analyses have been completed and published. Researchers requesting data must present an IRB-approved methodological protocol and explain the relevance of their interest in the study completed data to public health goals. Authors completing secondary analyses of the shared study data must agree to the Center for Clinical Trials and Data Coordination (CCDC) policy on data sharing and publishing. All secondary analysis authors will be expected to credit the primary investigators and mention the data source in all publications. Secondary authors will acknowledge that the data use was in accordance with CCDC protocol and the signed Data Use Agreement (DUA). The University of Pittsburgh Principal Investigator and study coordinator will not release any data until all request criteria are met and a signed Data Use Agreement is filed.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: The data will become available beginning 6 months and ending 36 months after the primary trial results are published.
ipd access criteria: All access will be thru the Center for Clinical Trials & Data Coordination (CCDC) at the University of Pittsburgh. Access will be monitored and controlled by our data center. No access will be granted until the initial requesting investigator vetting process is completed and a signed DUA is on file. All data safety plans and monitoring are listed on the CCDC website. Researchers interested in the data must sign a data use agreement (DUA) with the University of Pittsburgh, which must also be reviewed and agreed to by study partner CHASS Center Inc. No other data sharing options will be considered. The data that may be shared includes: de-identified participant data, tables, figures, appendices, analysis plan, and protocol.
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