<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/NCT01724125</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00012759</org_study_id>
    <secondary_id>1R18HS017829</secondary_id>
    <nct_id>NCT01724125</nct_id>
  </id_info>
  <brief_title>An Electronic Personal Health Record for Mental Health Consumers</brief_title>
  <official_title>An Electronic Personal Health Record for Mental Health Consumers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Agency for Healthcare Research and Quality (AHRQ)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Electronic Personal Health Records (PHRs) hold promise in helping reshape healthcare by&#xD;
      shifting the ownership and locus of health records from being scattered across multiple&#xD;
      providers to an approach that is longitudinal and patient-centered. Given the complex health&#xD;
      needs and the fragmentation of care for persons with serious mental illnesses, these&#xD;
      individuals could derive particular benefit from a PHR. However, there are currently no&#xD;
      established PHRs developed for use in this population.&#xD;
&#xD;
      In order to fill this gap, the investigators propose to develop, test, and disseminate a&#xD;
      Personal Health Record for persons with serious mental illnesses and one or more comorbid&#xD;
      medical condition. The Mental Health PHR (MH-PHR) builds on an established personal health&#xD;
      record which was developed in partnership with medical consumers and is in wide use in a&#xD;
      number of communities in the United States and abroad.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2009</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">September 2011</primary_completion_date>
  <phase>Phase 3</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>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of Care</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">170</enrollment>
  <condition>Chronic Comorbid Conditions</condition>
  <arm_group>
    <arm_group_label>Case</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Assigned a Personal Electronic Health Record</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control: Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Assigned to control arm, continued to receive care as usual in community. Was issued information on community health resources, but did not use research study personal health record.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>personal electronic medical record</intervention_name>
    <arm_group_label>Case</arm_group_label>
    <arm_group_label>Control: Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Currently in treatment at the CMHC.&#xD;
&#xD;
          2. Serious Mental Illness: based on or chart review;&#xD;
&#xD;
          3. One or more Chronic Medical Condition as ascertained via administrative records.&#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>Benjamin Druss, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Grady Health Systems</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>April 25, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 9, 2012</study_first_posted>
  <last_update_submitted>August 3, 2016</last_update_submitted>
  <last_update_submitted_qc>August 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Benjamin Druss</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>serious mental illness</keyword>
  <!-- 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/NCT01724125
org study id: IRB00012759
secondary id: 1R18HS017829
nct id: NCT01724125
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Electronic Personal Health Records (PHRs) hold promise in helping reshape healthcare by
      shifting the ownership and locus of health records from being scattered across multiple
      providers to an approach that is longitudinal and patient-centered. Given the complex health
      needs and the fragmentation of care for persons with serious mental illnesses, these
      individuals could derive particular benefit from a PHR. However, there are currently no
      established PHRs developed for use in this population.

      In order to fill this gap, the investigators propose to develop, test, and disseminate a
      Personal Health Record for persons with serious mental illnesses and one or more comorbid
      medical condition. The Mental Health PHR (MH-PHR) builds on an established personal health
      record which was developed in partnership with medical consumers and is in wide use in a
      number of communities in the United States and abroad.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Quality of Care
time frame: 1 year
arm group label: Case
arm group type: Experimental
description: Assigned a Personal Electronic Health Record
arm group label: Control: Usual Care
arm group type: Active Comparator
description: Assigned to control arm, continued to receive care as usual in community. Was issued information on community health resources, but did not use research study personal health record.
intervention type: Other
intervention name: personal electronic medical record
arm group label: Case
arm group label: Control: Usual Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Benjamin Druss, MD MPH
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Benjamin Druss
investigator title: Professor