<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/NCT02215655</url>
  </required_header>
  <id_info>
    <org_study_id>141143</org_study_id>
    <nct_id>NCT02215655</nct_id>
  </id_info>
  <brief_title>Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence</brief_title>
  <official_title>Increasing Autonomous Motivation in ESRD to Enhance Phosphate Binder Adherence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hyperphosphatemia in end-stage renal disease (ESRD) patients is a non-traditional risk factor&#xD;
      for all-cause and cardiovascular mortality. Non-adherence to phosphate binders is as high as&#xD;
      74% in ESRD patients and has been shown to be most related to psychosocial factors including&#xD;
      attitudes. There is limited data on the influence of attitudes and perceived autonomy support&#xD;
      on phosphate binder adherence and these two psychosocial constructs can be positively&#xD;
      influenced through the use of motivational interviewing skills to increase autonomous&#xD;
      motivation. Furthermore, racial disparities are known to exist in ESRD however and there are&#xD;
      still gaps, which exist in understanding the determinants of disparities in adherence in&#xD;
      vulnerable patients with ESRD.&#xD;
&#xD;
      In this study, the investigators seek to determine the impact of motivational interviewing on&#xD;
      phosphate binder adherence in diverse ESRD patients. The investigators will ask all the&#xD;
      subjects to fill out surveys mainly regarding their attitudes; perceived providers' autonomy&#xD;
      support and phosphate binder adherence. The investigators will administer motivational&#xD;
      counseling to subjects in the intervention arm of the study, at baseline and 1 month after&#xD;
      recruitment. The investigators will ask all the subjects to fill out the same surveys 2&#xD;
      months after recruitment and the investigators will compare subjects who underwent&#xD;
      motivational interviewing to those who did not.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</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>
  </study_design_info>
  <primary_outcome>
    <measure>change in subjects' adherence to phosphate binders</measure>
    <time_frame>baseline and 2 months</time_frame>
    <description>Change from baseline in the following survey at 2 months:&#xD;
- Morisky Medication Adherence Scale (MMAS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in attitudes towards phosphate binder therapy</measure>
    <time_frame>baseline and 2 months</time_frame>
    <description>Change from baseline in the following survey/questionnaire at 2 months:&#xD;
- Autonomous Regulation Scale (AR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in perceived providers' autonomy support towards phosphate binder therapy</measure>
    <time_frame>baseline and 2 months</time_frame>
    <description>Change from baseline in the following survey/questionnaire at 2 months:&#xD;
- Health Care Climate Questionnaire (HCC)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>End Stage Renal Disease</condition>
  <arm_group>
    <arm_group_label>Motivational interviewing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Motivational interviewing counselling will be administered to the subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No intervention: control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No motivational interviewing counselling will be administered to the subjects</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motivational interviewing</intervention_name>
    <description>Motivational interviewing counselling sessions will be administered to the subjects.</description>
    <arm_group_label>Motivational interviewing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults age 18 years or older&#xD;
&#xD;
          -  Receiving phosphate binder therapy currently&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non- English speaking&#xD;
&#xD;
          -  Known diagnosis of psychosis or dementia, limiting ability to provide informed consent&#xD;
&#xD;
          -  Any medical condition that precludes participation in the study including deafness,&#xD;
             dying etc.&#xD;
&#xD;
          -  Initial Morisky Medication Adherence score greater than 6&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ebele M Umeukeje, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>April 27, 2016</last_update_submitted>
  <last_update_submitted_qc>April 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University</investigator_affiliation>
    <investigator_full_name>Ebele Umeukeje</investigator_full_name>
    <investigator_title>Fellow</investigator_title>
  </responsible_party>
  <keyword>phosphate binder adherence</keyword>
  <keyword>autonomous motivation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <!-- 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/NCT02215655
org study id: 141143
nct id: NCT02215655
lead sponsor: 
has dmc: No
Hyperphosphatemia in end-stage renal disease (ESRD) patients is a non-traditional risk factor
      for all-cause and cardiovascular mortality. Non-adherence to phosphate binders is as high as
      74% in ESRD patients and has been shown to be most related to psychosocial factors including
      attitudes. There is limited data on the influence of attitudes and perceived autonomy support
      on phosphate binder adherence and these two psychosocial constructs can be positively
      influenced through the use of motivational interviewing skills to increase autonomous
      motivation. Furthermore, racial disparities are known to exist in ESRD however and there are
      still gaps, which exist in understanding the determinants of disparities in adherence in
      vulnerable patients with ESRD.

      In this study, the investigators seek to determine the impact of motivational interviewing on
      phosphate binder adherence in diverse ESRD patients. The investigators will ask all the
      subjects to fill out surveys mainly regarding their attitudes; perceived providers' autonomy
      support and phosphate binder adherence. The investigators will administer motivational
      counseling to subjects in the intervention arm of the study, at baseline and 1 month after
      recruitment. The investigators will ask all the subjects to fill out the same surveys 2
      months after recruitment and the investigators will compare subjects who underwent
      motivational interviewing to those who did not.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: change in subjects' adherence to phosphate binders
time frame: baseline and 2 months
description: Change from baseline in the following survey at 2 months:
- Morisky Medication Adherence Scale (MMAS)
measure: change in attitudes towards phosphate binder therapy
time frame: baseline and 2 months
description: Change from baseline in the following survey/questionnaire at 2 months:
- Autonomous Regulation Scale (AR)
measure: change in perceived providers' autonomy support towards phosphate binder therapy
time frame: baseline and 2 months
description: Change from baseline in the following survey/questionnaire at 2 months:
- Health Care Climate Questionnaire (HCC)
arm group label: Motivational interviewing
arm group type: Active Comparator
description: Motivational interviewing counselling will be administered to the subjects
arm group label: No intervention: control group
arm group type: No Intervention
description: No motivational interviewing counselling will be administered to the subjects
intervention type: Behavioral
intervention name: Motivational interviewing
description: Motivational interviewing counselling sessions will be administered to the subjects.
arm group label: Motivational interviewing
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ebele M Umeukeje, MD
role: Principal Investigator
affiliation: Vanderbilt University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University
investigator full name: Ebele Umeukeje
investigator title: Fellow
mesh term: Kidney Failure, Chronic