<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/NCT02967835</url>
  </required_header>
  <id_info>
    <org_study_id>16-003068</org_study_id>
    <nct_id>NCT02967835</nct_id>
  </id_info>
  <brief_title>Effectiveness and Satisfaction With Brief Synchronous Tele-psychiatry Consult</brief_title>
  <official_title>Pilot to Assess Effectiveness of and Satisfaction With Brief Synchronous Tele-psychiatry Consult</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
      Will Tele-psychiatry be effective and acceptable to patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This pilot aims to provide tele-psychiatry consults to patients at regional Mayo Clinic&#xD;
      Florida primary care sites. The primary aim of this study is to assess the impact of brief&#xD;
      tele-psychiatry consults on depression and anxiety outcomes for patients enrolled in complex&#xD;
      care management; the secondary aim is to assess patient satisfaction with brief&#xD;
      tele-psychiatry consults.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    not able to recruit&#xD;
  </why_stopped>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">June 14, 2017</completion_date>
  <primary_completion_date type="Actual">June 14, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depression Outcome</measure>
    <time_frame>6 month</time_frame>
    <description>Will measure depression outcome by measuring PHQ9 score at baseline and 6 months after initial tele-psychiatry consult.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety Outcome</measure>
    <time_frame>6 month</time_frame>
    <description>Will measure Anxiety outcome by using GAD7 score at baseline and 6 months after initial tele-psychiatry consult.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction with tele-psychiatry consult</measure>
    <time_frame>baseline visit</time_frame>
    <description>Assess patient satisfaction with tele-psychiatry consult at baseline visit by use of patient satisfaction questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Telepsychiatry Consult</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One time tele-psychiatry consultation to provide treatment recommendations for patients primary care physician.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tele-psychiatry consult</intervention_name>
    <description>tele-psychiatry consult for evaluation and treatment recommendations</description>
    <arm_group_label>Telepsychiatry Consult</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Enrolled in complex care management&#xD;
&#xD;
          2. PHQ9 above 10 or GAD7 above 10.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Not able to provide informed consent&#xD;
&#xD;
          2. Severe cognitive impairments or sensory deficits&#xD;
&#xD;
          3. Not able to understand and speak English&#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>Mohit Chauhan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 12, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>February 5, 2019</last_update_submitted>
  <last_update_submitted_qc>February 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Mohit Chauhan, M.B.B.S.</investigator_full_name>
    <investigator_title>Senior Associate Consultant</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</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/NCT02967835
org study id: 16-003068
nct id: NCT02967835
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Will Tele-psychiatry be effective and acceptable to patients.
This pilot aims to provide tele-psychiatry consults to patients at regional Mayo Clinic
      Florida primary care sites. The primary aim of this study is to assess the impact of brief
      tele-psychiatry consults on depression and anxiety outcomes for patients enrolled in complex
      care management; the secondary aim is to assess patient satisfaction with brief
      tele-psychiatry consults.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Depression Outcome
time frame: 6 month
description: Will measure depression outcome by measuring PHQ9 score at baseline and 6 months after initial tele-psychiatry consult.
measure: Anxiety Outcome
time frame: 6 month
description: Will measure Anxiety outcome by using GAD7 score at baseline and 6 months after initial tele-psychiatry consult.
measure: Patient satisfaction with tele-psychiatry consult
time frame: baseline visit
description: Assess patient satisfaction with tele-psychiatry consult at baseline visit by use of patient satisfaction questionnaire.
arm group label: Telepsychiatry Consult
arm group type: Experimental
description: One time tele-psychiatry consultation to provide treatment recommendations for patients primary care physician.
intervention type: Behavioral
intervention name: Tele-psychiatry consult
description: tele-psychiatry consult for evaluation and treatment recommendations
arm group label: Telepsychiatry Consult
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mohit Chauhan
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Mohit Chauhan, M.B.B.S.
investigator title: Senior Associate Consultant
mesh term: Depression
sharing ipd: No