<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/NCT01684709</url>
  </required_header>
  <id_info>
    <org_study_id>DK088294</org_study_id>
    <secondary_id>1R18DK088294-01</secondary_id>
    <nct_id>NCT01684709</nct_id>
  </id_info>
  <brief_title>Enhancing Informal Caregiving to Support Diabetes Self-Management</brief_title>
  <official_title>Enhancing Informal Caregiving to Support Diabetes Self-Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares the medical and psychological effects of telemonitoring plus intensified&#xD;
      self-management support to those of usual care alone for patients with poorly controlled type&#xD;
      2 diabetes mellitus (DM). If this intervention proves effective without increasing costs or&#xD;
      clinician burden, then its implementation could yield major public health benefits,&#xD;
      especially for vulnerable and underserved DM patients, and broader societal benefit may occur&#xD;
      through increased helping behavior and strengthened social ties.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although in-home caregivers (ICGs) help improve diabetes mellitus (DM) outcomes, they may&#xD;
      lack the resources needed to do this optimally, and are at risk for psychosocial decline and&#xD;
      caregiver burnout. Complicating matters, millions of chronically-ill older Americans live&#xD;
      alone and receive long-distance caregiving without any supporting structure or resources to&#xD;
      ensure its effectiveness. In this study, diabetes patients with poor glycemic will be&#xD;
      recruited from two clinical sites, and half will have an ICG. Patients will nominate a&#xD;
      &quot;CarePartner&quot; (CP; adult relatives or friends from outside their home) to receive weekly&#xD;
      email reports about their DM health and behavioral needs, and will be given resources to help&#xD;
      them to provide self-management support. Patients will then be randomized to receive either&#xD;
      one year of CP intervention or usual medical care. In the CP intervention arm, patients will&#xD;
      provide weekly updates on their DM health and self-management through weekly automated&#xD;
      telemonitoring. Summaries of this will be emailed to their CP along with guidance on helping&#xD;
      the patient address reported problem(s), and their clinicians will be alerted about&#xD;
      medically-urgent problems. We will assess the following outcomes in both arms before&#xD;
      intervention and also after 6 and 12 months of intervention: glycemic control, DM-related&#xD;
      distress, DM self-management, health-related quality of life, systolic blood pressure,&#xD;
      caregiver burden, relationship quality, and cost of DM care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">September 26, 2017</completion_date>
  <primary_completion_date type="Actual">September 26, 2017</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>12-month glycemic control</measure>
    <time_frame>12 months</time_frame>
    <description>H1 (Primary biological outcome): Compared to DM patients randomized to control, those randomized to intervention will have a 0.3% greater improvement in HbA1c units.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary effects upon adjustment to diabetes</measure>
    <time_frame>12 months</time_frame>
    <description>Compared to controls, intervention patients will have lower diabetes related distress.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">864</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Telemonitoring + self-management support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Automated assessment calls with follow-up by a Care Manager and a CarePartner for 12 months. Baseline, 6 month, and 12 month follow-up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual Care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telemonitoring + self-management support</intervention_name>
    <description>Weekly automated assessment calls with follow-up by a care manager and a CarePartner for 12 months. Baseline, 6 month, and 12 month follow-up</description>
    <arm_group_label>Telemonitoring + self-management support</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  type 2 DM (hospitalization or outpatient visit within 12 months for &gt;2 ICD9 codes of&#xD;
             250.xx or therapeutic class codes C4G, C4K, or C4L in past 2 years' problem list)&#xD;
&#xD;
          -  poor glycemic control (recent HbA1c% &gt;7.5)&#xD;
&#xD;
          -  at least 21 years old&#xD;
&#xD;
          -  fluent in English&#xD;
&#xD;
          -  can use telephone numeric touchtone keypad&#xD;
&#xD;
          -  can identify 1-4 eligible CPs&#xD;
&#xD;
          -  not in palliative care, on transplant waitlist, or at high risk for 1-year mortality&#xD;
&#xD;
          -  free of major psychiatric or cognitive impairment.&#xD;
&#xD;
          -  ICGs: We will stratify recruitment within sites so that 50% of enrolled patients have&#xD;
             an ICG.&#xD;
&#xD;
          -  Patients with an ICG cannot enroll unless their ICG also provides consent.&#xD;
&#xD;
          -  has a CP that resides in continental US but outside patient's household; has&#xD;
             communicated with patient, in person or by phone, at least once monthly over preceding&#xD;
             6 months; has a home telephone or mobile cell phone; has an internet connection; can&#xD;
             communicate via e-mail; is free of severe psychiatric/cognitive impairment; is fluent&#xD;
             in English; and is at least 21 years of age.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Limited life expectancy (e.g., advanced stage cancer/heart failure/on oxygen/end stage&#xD;
             renal disease), receiving palliative care&#xD;
&#xD;
          -  active alcohol or drug abuse&#xD;
&#xD;
          -  dementia, bipolar disorder, schizophrenia&#xD;
&#xD;
          -  unable to speak English&#xD;
&#xD;
          -  not planning to get all or most of care at study site&#xD;
&#xD;
          -  primary care physician not affiliated with study site&#xD;
&#xD;
          -  unable to use a telephone to respond to weekly automated self-management support calls&#xD;
&#xD;
          -  unable to nominate an eligible CP&#xD;
&#xD;
          -  ICG (if present) does not consent to participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James E Aikens, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamilton Health Center</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Family Health</name>
      <address>
        <city>Jackson</city>
        <state>Michigan</state>
        <zip>49201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alcona Health Center</name>
      <address>
        <city>Lincoln</city>
        <state>Michigan</state>
        <zip>48742</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Muskegon Family Care</name>
      <address>
        <city>Muskegon Heights</city>
        <state>Michigan</state>
        <zip>49444</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. John Masonic Medical Center</name>
      <address>
        <city>Saint Clair Shores</city>
        <state>Michigan</state>
        <zip>48082</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <last_update_submitted>October 23, 2017</last_update_submitted>
  <last_update_submitted_qc>October 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>James Aikens, PhD</investigator_full_name>
    <investigator_title>Associate Professor of Family Medicine</investigator_title>
  </responsible_party>
  <keyword>Type 2 Diabetes</keyword>
  <keyword>Informal Caregivers</keyword>
  <keyword>Self Care</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Health Information Technology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Pending IRB approval.</ipd_description>
  </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/NCT01684709
org study id: DK088294
secondary id: 1R18DK088294-01
nct id: NCT01684709
lead sponsor: 
collaborator: 
has dmc: Yes
This study compares the medical and psychological effects of telemonitoring plus intensified
      self-management support to those of usual care alone for patients with poorly controlled type
      2 diabetes mellitus (DM). If this intervention proves effective without increasing costs or
      clinician burden, then its implementation could yield major public health benefits,
      especially for vulnerable and underserved DM patients, and broader societal benefit may occur
      through increased helping behavior and strengthened social ties.
Although in-home caregivers (ICGs) help improve diabetes mellitus (DM) outcomes, they may
      lack the resources needed to do this optimally, and are at risk for psychosocial decline and
      caregiver burnout. Complicating matters, millions of chronically-ill older Americans live
      alone and receive long-distance caregiving without any supporting structure or resources to
      ensure its effectiveness. In this study, diabetes patients with poor glycemic will be
      recruited from two clinical sites, and half will have an ICG. Patients will nominate a
      "CarePartner" (CP; adult relatives or friends from outside their home) to receive weekly
      email reports about their DM health and behavioral needs, and will be given resources to help
      them to provide self-management support. Patients will then be randomized to receive either
      one year of CP intervention or usual medical care. In the CP intervention arm, patients will
      provide weekly updates on their DM health and self-management through weekly automated
      telemonitoring. Summaries of this will be emailed to their CP along with guidance on helping
      the patient address reported problem(s), and their clinicians will be alerted about
      medically-urgent problems. We will assess the following outcomes in both arms before
      intervention and also after 6 and 12 months of intervention: glycemic control, DM-related
      distress, DM self-management, health-related quality of life, systolic blood pressure,
      caregiver burden, relationship quality, and cost of DM care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: 12-month glycemic control
time frame: 12 months
description: H1 (Primary biological outcome): Compared to DM patients randomized to control, those randomized to intervention will have a 0.3% greater improvement in HbA1c units.
measure: Secondary effects upon adjustment to diabetes
time frame: 12 months
description: Compared to controls, intervention patients will have lower diabetes related distress.
arm group label: Telemonitoring + self-management support
arm group type: Experimental
description: Automated assessment calls with follow-up by a Care Manager and a CarePartner for 12 months. Baseline, 6 month, and 12 month follow-up.
arm group label: Usual Care
arm group type: No Intervention
description: Usual Care
intervention type: Behavioral
intervention name: Telemonitoring + self-management support
description: Weekly automated assessment calls with follow-up by a care manager and a CarePartner for 12 months. Baseline, 6 month, and 12 month follow-up
arm group label: Telemonitoring + self-management support
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: James E Aikens, PhD
role: Principal Investigator
affiliation: University of Michigan
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: James Aikens, PhD
investigator title: Associate Professor of Family Medicine
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: Undecided
ipd description: Pending IRB approval.