xml: <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/NCT06019143</url>
    </required_header>
    <id_info>
      <org_study_id>GoalNavRCC2023</org_study_id>
      <nct_id>NCT06019143</nct_id>
    </id_info>
    <brief_title>GoalNav® Clinic Module - Pilot Trial</brief_title>
    <official_title>GoalNav® Clinic Module - Pilot Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ardea Outcomes</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Research Council, Canada</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Ardea Outcomes</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a pilot study to test the feasibility of GoalNav® Clinic, an Electronic Data Capture&#xD;
        platform which is specifically designed to collect data on patient goals, live in a clinical&#xD;
        setting.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Goal Attainment Scaling (GAS) is an individualized outcome measure that quantifies the&#xD;
        effects of an intervention based on personalized goals.&#xD;
  &#xD;
        Ardea Outcomes has developed an electronic data capture system called GoalNav® Clinic that is&#xD;
        designed to capture GAS data (individual goals) in addition to other outcome measures that is&#xD;
        useful to the doctor such as assessment information, patient demographics, cognitive status,&#xD;
        etc..&#xD;
  &#xD;
        With the help of a study doctor and/or a member of the research team trained in the process&#xD;
        of conducting GAS interviews, patients and/or care partners set goals that are meaningful and&#xD;
        relevant to them or their loved one's condition. Goals are then followed up in three months,&#xD;
        and ratings are provided by the GAS interviewer and patient and/or care partner.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Goal Setting Survey</measure>
      <time_frame>4 months</time_frame>
      <description>The goal setting survey includes multiple choice, Likert type and open-ended questions with respect to the feasibility and acceptability of Goal Attainment Scaling. The questions focus on the impressions and experiences of patients and care partners (in Arm A and Arm B), and the study doctors when conducting interviews using GoalNav® EDC with and without goal inventory. The percentage of participants agreeing with statements with respect to ease of use, time commitment, etc. will be the unit of measurement. The answers to the open-ended questions will also be qualitatively analyzed.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>GAS Interviewer Individual Qualitative Interview</measure>
      <time_frame>4 months</time_frame>
      <description>The one-hour qualitative interview with GAS interviewers will include questions such as&#xD;
  did GAS interviewers use the goal inventory for participants in Arm B (no goal inventory)?&#xD;
  was there a difference between Arm A and Arm B in the goal setting process?&#xD;
  was there a difference between Arm A and Arm B in goal quality?&#xD;
  did patients and care partners in Arm B find it difficult to identify challenges or goal areas without sufficient prompts?</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Geriatric Assessment</condition>
    <arm_group>
      <arm_group_label>Arm A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Goal Attainment Scaling (GAS) with goal inventory</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm B</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Goal Attainment Scaling (GAS) without goal inventory</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Goal Attainment Scaling (GAS) with a goal inventory</intervention_name>
      <description>Goal Attainment Scaling (GAS) with a goal inventory (list of common goals) as a behavioral interventional tool</description>
      <arm_group_label>Arm A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Goal Attainment Scaling (GAS) without inventory</intervention_name>
      <description>Goal Attainment Scaling (GAS) without a goal inventory (list of common goals) as a behavioral interventional tool</description>
      <arm_group_label>Arm B</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  a new or returning patient who has been referred and has a pre-scheduled appointment&#xD;
               to the study doctor's clinic for a geriatric assessment&#xD;
  &#xD;
            -  of any age, with or without a disease diagnosis/memory complaint&#xD;
  &#xD;
            -  the patient is accompanied by a family member or friend who is willing to participate&#xD;
  &#xD;
            -  the patient and/or their care partner must be able to respond to questions in English&#xD;
  &#xD;
            -  the patient and their care partner give informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  the patient does not have a family member or friend who is willing to participate&#xD;
  &#xD;
            -  neither the patient nor their care partner can respond to questions in English&#xD;
  &#xD;
            -  either or both the patient and care partner decline to provide informed consent&#xD;
  &#xD;
            -  the study doctor deems that the patient and/or care partner is not suitable for the&#xD;
               study&#xD;
  &#xD;
            -  either the patient or their care partner indicates on the informed consent form that&#xD;
               they do not wish to be contacted by email or by telephone&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Arlene Kelly-Wiggins, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Nova Scotial Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sue Nesto, MA</last_name>
      <phone>902-580-7943</phone>
      <email>sue.nesto@ardeaoutcomes.com</email>
    </overall_contact>
    <reference>
      <citation>Kiresuk TJ, Sherman RE. Goal attainment scaling: A general method for evaluating comprehensive community mental health programs. Community Ment Health J. 1968 Dec;4(6):443-53. doi: 10.1007/BF01530764.</citation>
      <PMID>24185570</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06019143
  org study id: GoalNavRCC2023
  nct id: NCT06019143
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a pilot study to test the feasibility of GoalNav® Clinic, an Electronic Data Capture
        platform which is specifically designed to collect data on patient goals, live in a clinical
        setting.
  Goal Attainment Scaling (GAS) is an individualized outcome measure that quantifies the
        effects of an intervention based on personalized goals.
  
        Ardea Outcomes has developed an electronic data capture system called GoalNav® Clinic that is
        designed to capture GAS data (individual goals) in addition to other outcome measures that is
        useful to the doctor such as assessment information, patient demographics, cognitive status,
        etc..
  
        With the help of a study doctor and/or a member of the research team trained in the process
        of conducting GAS interviews, patients and/or care partners set goals that are meaningful and
        relevant to them or their loved one's condition. Goals are then followed up in three months,
        and ratings are provided by the GAS interviewer and patient and/or care partner.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Goal Setting Survey
  time frame: 4 months
  description: The goal setting survey includes multiple choice, Likert type and open-ended questions with respect to the feasibility and acceptability of Goal Attainment Scaling. The questions focus on the impressions and experiences of patients and care partners (in Arm A and Arm B), and the study doctors when conducting interviews using GoalNav® EDC with and without goal inventory. The percentage of participants agreeing with statements with respect to ease of use, time commitment, etc. will be the unit of measurement. The answers to the open-ended questions will also be qualitatively analyzed.
  measure: GAS Interviewer Individual Qualitative Interview
  time frame: 4 months
  description: The one-hour qualitative interview with GAS interviewers will include questions such as
  did GAS interviewers use the goal inventory for participants in Arm B (no goal inventory)?
  was there a difference between Arm A and Arm B in the goal setting process?
  was there a difference between Arm A and Arm B in goal quality?
  did patients and care partners in Arm B find it difficult to identify challenges or goal areas without sufficient prompts?
  arm group label: Arm A
  arm group type: Experimental
  description: Goal Attainment Scaling (GAS) with goal inventory
  arm group label: Arm B
  arm group type: Active Comparator
  description: Goal Attainment Scaling (GAS) without goal inventory
  intervention type: Behavioral
  intervention name: Goal Attainment Scaling (GAS) with a goal inventory
  description: Goal Attainment Scaling (GAS) with a goal inventory (list of common goals) as a behavioral interventional tool
  arm group label: Arm A
  intervention type: Behavioral
  intervention name: Goal Attainment Scaling (GAS) without inventory
  description: Goal Attainment Scaling (GAS) without a goal inventory (list of common goals) as a behavioral interventional tool
  arm group label: Arm B
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Arlene Kelly-Wiggins, MD
  role: Principal Investigator
  affiliation: Nova Scotial Health
  last name: Sue Nesto, MA
  phone: 902-580-7943
  email: sue.nesto@ardeaoutcomes.com
  citation: Kiresuk TJ, Sherman RE. Goal attainment scaling: A general method for evaluating comprehensive community mental health programs. Community Ment Health J. 1968 Dec;4(6):443-53. doi: 10.1007/BF01530764.
  PMID: 24185570
  responsible party type: Sponsor