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/NCT05996718</url>
    </required_header>
    <id_info>
      <org_study_id>P30AG064200</org_study_id>
      <secondary_id>DBSR-11114</secondary_id>
      <nct_id>NCT05996718</nct_id>
    </id_info>
    <brief_title>Improving Care Through Improv: Promoting Mastery in the Moment</brief_title>
    <official_title>Improving Care Through Improv: Promoting Mastery in the Moment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Georgia State University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute on Aging (NIA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Georgia State University</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>
        The goals of this clinical trial are to: 1) refine the training program, &quot;Improving Care&#xD;
        though Improv;&quot; and 2) test the program for its influence self-perceived caregiving mastery&#xD;
        (i.e., how persons assess their ability to provide care) among informal caregivers of persons&#xD;
        living with moderate dementia. Forty informal caregivers will be involved in testing the&#xD;
        training program. These individuals will be assigned to groups of between 8 to12 caregivers&#xD;
        and take part in weekly 2-hour sessions held over a 4-week period. These caregivers will be&#xD;
        taught improvisational (improv) theater skills, which involves being in the moment,&#xD;
        self-awareness, and responsiveness to others. This group also will be asked to answer surveys&#xD;
        questions about themselves and the person receiving care at three timepoints and invited to&#xD;
        provide feedback on their training experiences.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">May 2024</completion_date>
    <primary_completion_date type="Anticipated">April 2024</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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pearlin Mastery, Loss, and Competence: Caregiver Competence Subscale</measure>
      <time_frame>at baseline, upon training completion (Week 4), and three months post baseline.</time_frame>
      <description>4-item Likert-type scale; scores range from 4 to 16 with higher scores indicating greater feelings of competence.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Perceived Stress Scale</measure>
      <time_frame>at baseline, upon training completion (Week 4), and three months post baseline.</time_frame>
      <description>14-item Likert-type scale. Scores range from 0 to 56 with higher scores indicating greater stress.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Center for Epidemiological Studies-Depression Scale</measure>
      <time_frame>at baseline, upon training completion (Week 4), and three months post baseline.</time_frame>
      <description>20-item Likert-type scale. Scores range from 0 to 60 with higher scores indicating greater depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>State-Trait Anxiety Inventory</measure>
      <time_frame>at baseline, upon training completion (Week 4), and three months post baseline.</time_frame>
      <description>20-item Likert-type scale. Scores range from 20 to 80 with higher scores indicating greater anxiety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Zarit Burden Inventory</measure>
      <time_frame>at baseline, upon training completion (Week 4), and three months post baseline.</time_frame>
      <description>22-item scale with 4-point Likert scale responses. Scores range from 0 to 88 with higher scores indicating greater burden.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Revised Memory and Behavioral Problems Checklist</measure>
      <time_frame>at baseline, upon training completion (Week 4), and three months post baseline.</time_frame>
      <description>24-item scale with 4-point Likert scale responses. Scores range from 0 to 96 with higher scores indicating greater behavioral expressions observed by caregivers among persons living with dementia.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Life-Alzheimer's Disease Scale</measure>
      <time_frame>at baseline, upon training completion (Week 4), and three months post baseline.</time_frame>
      <description>13 items with a 4-point Likert scale. Scores range from 13 to with 52 with higher scores indicating greater quality of life among persons living with dementia</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Caregiver Burden</condition>
    <arm_group>
      <arm_group_label>Informal Caregivers of Persons Living with Dementia</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive the training program, &quot;Improving Care through Improv.&quot; This involves four weekly 2-hour in-person training sessions.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Training program pilot</intervention_name>
      <description>This intervention for informal caregivers consists of training that will introduce participants to improvisational (improv) theatre and teach its core communication skills.</description>
      <arm_group_label>Informal Caregivers of Persons Living with Dementia</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Actively engaged in the care of community-dwelling persons living with moderate&#xD;
               dementia (4 or 5 on a 7-point dementia-staging scale) who is not likely to be&#xD;
               institutionalized within the next 6 months&#xD;
  &#xD;
            -  Able to attend at least 3 of the 4 in-person sessions&#xD;
  &#xD;
            -  Ability to communicate in English&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Candace L Kemp, PhD</last_name>
      <phone>404-413-5216</phone>
      <email>ckemp@gsu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Crystal W Williams, DrPH</last_name>
      <email>cwilliams259@gsu.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Georgia State University</investigator_affiliation>
      <investigator_full_name>Candace Kemp</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Caregiver Burden</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Data from this study will be made available to qualified researchers through a data sharing agreement that is consistent with NIH data sharing policies, as well as policies and practices established by the Roybal Center for Dementia Caregiving Mastery at Emory University. The data to be collected include common data elements, including the Caregiver Mastery Scale developed by Pearlin and colleagues, as well as demographic characteristics. Although these data will be de-identified prior to release for sharing, there remains a possibility of deductive disclosure of participants with unusual characteristics. Therefore, this data sharing agreement will require: 1) a commitment only to use the data for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroy or return the data after analyses are completed.</ipd_description>
      <ipd_time_frame>Study data will be made available no later than the on-line publication date of the main findings from the final dataset.</ipd_time_frame>
      <ipd_access_criteria>Researchers must qualify and enter into a data sharing agreement. The agreement requires: 1) a commitment only to use the data for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroy or return the data after analyses are completed.</ipd_access_criteria>
    </patient_data>
    <!-- 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/NCT05996718
  org study id: P30AG064200
  secondary id: DBSR-11114
  nct id: NCT05996718
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goals of this clinical trial are to: 1) refine the training program, "Improving Care
        though Improv;" and 2) test the program for its influence self-perceived caregiving mastery
        (i.e., how persons assess their ability to provide care) among informal caregivers of persons
        living with moderate dementia. Forty informal caregivers will be involved in testing the
        training program. These individuals will be assigned to groups of between 8 to12 caregivers
        and take part in weekly 2-hour sessions held over a 4-week period. These caregivers will be
        taught improvisational (improv) theater skills, which involves being in the moment,
        self-awareness, and responsiveness to others. This group also will be asked to answer surveys
        questions about themselves and the person receiving care at three timepoints and invited to
        provide feedback on their training experiences.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Pearlin Mastery, Loss, and Competence: Caregiver Competence Subscale
  time frame: at baseline, upon training completion (Week 4), and three months post baseline.
  description: 4-item Likert-type scale; scores range from 4 to 16 with higher scores indicating greater feelings of competence.
  measure: Perceived Stress Scale
  time frame: at baseline, upon training completion (Week 4), and three months post baseline.
  description: 14-item Likert-type scale. Scores range from 0 to 56 with higher scores indicating greater stress.
  measure: Center for Epidemiological Studies-Depression Scale
  time frame: at baseline, upon training completion (Week 4), and three months post baseline.
  description: 20-item Likert-type scale. Scores range from 0 to 60 with higher scores indicating greater depression.
  measure: State-Trait Anxiety Inventory
  time frame: at baseline, upon training completion (Week 4), and three months post baseline.
  description: 20-item Likert-type scale. Scores range from 20 to 80 with higher scores indicating greater anxiety.
  measure: Zarit Burden Inventory
  time frame: at baseline, upon training completion (Week 4), and three months post baseline.
  description: 22-item scale with 4-point Likert scale responses. Scores range from 0 to 88 with higher scores indicating greater burden.
  measure: Revised Memory and Behavioral Problems Checklist
  time frame: at baseline, upon training completion (Week 4), and three months post baseline.
  description: 24-item scale with 4-point Likert scale responses. Scores range from 0 to 96 with higher scores indicating greater behavioral expressions observed by caregivers among persons living with dementia.
  measure: Quality of Life-Alzheimer's Disease Scale
  time frame: at baseline, upon training completion (Week 4), and three months post baseline.
  description: 13 items with a 4-point Likert scale. Scores range from 13 to with 52 with higher scores indicating greater quality of life among persons living with dementia
  arm group label: Informal Caregivers of Persons Living with Dementia
  arm group type: Experimental
  description: Participants will receive the training program, "Improving Care through Improv." This involves four weekly 2-hour in-person training sessions.
  intervention type: Behavioral
  intervention name: Training program pilot
  description: This intervention for informal caregivers consists of training that will introduce participants to improvisational (improv) theatre and teach its core communication skills.
  arm group label: Informal Caregivers of Persons Living with Dementia
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Candace L Kemp, PhD
  phone: 404-413-5216
  email: ckemp@gsu.edu
  last name: Crystal W Williams, DrPH
  email: cwilliams259@gsu.edu
  responsible party type: Principal Investigator
  investigator affiliation: Georgia State University
  investigator full name: Candace Kemp
  investigator title: Professor
  mesh term: Caregiver Burden
  sharing ipd: Yes
  ipd description: Data from this study will be made available to qualified researchers through a data sharing agreement that is consistent with NIH data sharing policies, as well as policies and practices established by the Roybal Center for Dementia Caregiving Mastery at Emory University. The data to be collected include common data elements, including the Caregiver Mastery Scale developed by Pearlin and colleagues, as well as demographic characteristics. Although these data will be de-identified prior to release for sharing, there remains a possibility of deductive disclosure of participants with unusual characteristics. Therefore, this data sharing agreement will require: 1) a commitment only to use the data for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroy or return the data after analyses are completed.
  ipd time frame: Study data will be made available no later than the on-line publication date of the main findings from the final dataset.
  ipd access criteria: Researchers must qualify and enter into a data sharing agreement. The agreement requires: 1) a commitment only to use the data for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroy or return the data after analyses are completed.