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/NCT06030050</url>
    </required_header>
    <id_info>
      <org_study_id>20230396HU</org_study_id>
      <nct_id>NCT06030050</nct_id>
    </id_info>
    <brief_title>Animal Assisted Intervention for Hemodialysis Outpatients</brief_title>
    <official_title>Animal Assisted Intervention for Hemodialysis Outpatients: A Mixed-method Randomized Controlled Trial for Treatment Adherence and Psychosocial Well-being</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The University of Texas Health Science Center at San Antonio</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>U.S. Renal Care, Inc.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>The University of Texas Health Science Center at San Antonio</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>
        The goal of this clinical trial is to understand if and how an animal-assisted intervention&#xD;
        [AAI] using therapy dogs can support hemodialysis [HD] patients' treatment adherence and&#xD;
        enhance their well-being. The main objectives are:&#xD;
  &#xD;
          -  Objective 1: Determine if the AAI impacts patients' HD treatment adherence (primary&#xD;
             outcome is number of unplanned missed treatments no due to hospitalization).&#xD;
  &#xD;
          -  Objective 2: Evaluate if the AAI impacts patients' psychosocial well-being (secondary&#xD;
             outcomes are stress, pain, mood, QOL).&#xD;
  &#xD;
          -  Objective 3: Examine potential mechanistic biomarkers that underpin human-animal bonding&#xD;
             (hormones tied to stress and bonding). (exploratory aim)&#xD;
  &#xD;
          -  Objective 4: Understand patients' subjective experiences of the AAI.&#xD;
  &#xD;
        Participants will be asked to engage in several research tasks, including:&#xD;
  &#xD;
          -  assessments&#xD;
  &#xD;
          -  therapy dog visits&#xD;
  &#xD;
          -  monthly blood draws&#xD;
  &#xD;
          -  focus group&#xD;
  &#xD;
        Researchers will compare how the treatment group (those who receive 2 dogs visits per week)&#xD;
        and the control group (those who receive 0 dog visits per week) to see if the AAI impacts&#xD;
        treatment adherence and psychosocial well-being.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will take place in one outpatient dialysis clinic. The clinical trial will compare&#xD;
        a standardized therapy dog interaction delivered twice weekly (based on pilot study outcomes&#xD;
        detailed below) to usual care (e.g., no dog exposure) using a 1:1 randomized, 2-arm design.&#xD;
        Subjective patient-reported outcomes [PRO] and routinely-tracked clinic data (e.g., missed&#xD;
        visits) will be used. A total of 30 patients will be recruited then randomized 1:1 into 2&#xD;
        arms: control group with 0 dog visits (n = 15) and intervention group with 2 dog visits per&#xD;
        week for 20 weeks (n = 15). The AAI is designed to promote patient comfort, uplift mood, and&#xD;
        provide an opportunity for socialization. The nature of the dog interaction involves several&#xD;
        different components, including but not limited to: petting the dog, talking to the dog,&#xD;
        watching the dog do tricks, conversing with the dog handler, and being prompted to discuss&#xD;
        any fond memories/stories of their own personal experiences with human-animal interactions.&#xD;
        Regarding duration, the dog visits average 10 minutes but will be allowed to vary, and length&#xD;
        of dog visits will be tracked. Each team (dog handler + dog) will have an assigned unique ID&#xD;
        so that variation in dog is controlled for. This study will utilize trained certified dog&#xD;
        handlers to deliver the intervention from reputable local and national pet therapy&#xD;
        organizations. All dogs have gone through extensive training and behavioral assessment, will&#xD;
        provide proper documentation, liability insurance, and vaccinations. All study procedures&#xD;
        take place in the clinic waiting room. Patient-reported outcomes (PRO)s will be collected as&#xD;
        pre-post data (before and after dog visit or lobby-as-usual control condition). All PROs will&#xD;
        be collected electronically on iPads using REDcap. Regarding treatment adherence data, the&#xD;
        clinic routinely tracks missed appointments and will report these metrics directly to&#xD;
        research team. Patients will complete assessments 2 times per week for a total of 20 weeks. A&#xD;
        short demographic questionnaire will be administered once at the first study visit. Also,&#xD;
        patients will also undergo a monthly blood-draw providing 3mL of blood 1 time a month at the&#xD;
        same time as their standard of care blood draw. This will be bio-banked in a repository for&#xD;
        later ELISA analyses, which will focus on hormones related to stress and bonding (e.g.,&#xD;
        oxytocin, cortisol); this may provide insight into mechanistic biomarkers underpinning the&#xD;
        human-animal bonding process. Lastly, qualitative focus groups with intervention group&#xD;
        participants will be conducted post-trial to learn about their subjective experiences of the&#xD;
        AAI.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 31, 2023</start_date>
    <completion_date type="Anticipated">February 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</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>Treatment adherence</measure>
      <time_frame>20 weeks</time_frame>
      <description>Number of unplanned missed hemodialysis treatment sessions not due to hospitalizations</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Affective distress</measure>
      <time_frame>20 weeks</time_frame>
      <description>Anxiety &amp; depression (PHQ-4). This is 4 items. Total score is determined by adding together the scores of each of the 4 items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score ≥3 for first 2 questions suggests anxiety. Total score ≥3 for last 2 questions suggests depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain unpleasantness</measure>
      <time_frame>20 weeks</time_frame>
      <description>Pain unpleasantness (Numeric Rating Scale 0-10) This is 1 item. higher score means worse pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain intensity</measure>
      <time_frame>20 weeks</time_frame>
      <description>Pain intensity (PROMIS-SF). This is 3 items, score range 3 - 15 (raw scores) , higher scores indicate worse pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stress</measure>
      <time_frame>20 weeks</time_frame>
      <description>Subjective psychological stress (Stress symptom scale). 1 item, 5-point likert scale, higher score indicates greater stress.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dog bonding</measure>
      <time_frame>20 weeks</time_frame>
      <description>Human Animal Bond Scale. Emotionality sub-scale (7 items). 5-pt likert scale. Higher scores indicate higher levels of bonding between human and animal.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Companionship</measure>
      <time_frame>20 weeks</time_frame>
      <description>Social togetherness (PROMIS-SF companionship). 4 items. 5-pt likert scale. Higher scores indicate higher levels of companionship.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Social Support</measure>
      <time_frame>20 weeks</time_frame>
      <description>Emotional support (PROMIS-SF Emotional support). 4 items. 5-pt likert scale. Higher scores indicate higher levels of support.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived subjective Quality of life</measure>
      <time_frame>20 weeks</time_frame>
      <description>Perceived overall quality (Kemp QOL scale). 1 item. 7-pt likert scale, higher score indicates better perceived quality of life.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>End-Stage Kidney Disease</condition>
    <condition>Chronic Kidney Failure</condition>
    <condition>Chronic Pain</condition>
    <arm_group>
      <arm_group_label>Treatment group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Intervention: Animal-assisted intervention (therapy dog visit) Frequency: 2 dog visits per week Duration: each visit is approx 10 mins long, study lasts 20 weeks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Intervention: NONE - sit in waiting room like usual Frequency: 0 dog visits per week Duration: study lasts 20 weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Animal-assisted intervention</intervention_name>
      <description>The AAI is designed to promote patient comfort, uplift mood, and provide an opportunity for socialization. The nature of the dog interaction involves several different components, including but not limited to: petting the dog, talking to the dog, watching the dog do tricks, conversing with the dog handler, and being prompted to discuss any fond memories/stories of their own personal experiences with human-animal interactions. Therapy dogs are trained and certified animals who are leashed at all times and under direct care of their dog handler, NOT companion animals, personal pets, nor emotional support animals.</description>
      <arm_group_label>Treatment group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  current HD patient&#xD;
  &#xD;
            -  aged 18+,&#xD;
  &#xD;
            -  English speaking, -≥2 missed HD treatments in the last 90 days.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  not an HD patient currently&#xD;
  &#xD;
            -  aged younger than 18 years old&#xD;
  &#xD;
            -  lacks proficiency in English speaking and reading&#xD;
  &#xD;
            -  has only 1 or less missed HD treatments in the last 90 days.&#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>Meredith L Stensland, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The University of Texas Health Science Center at San Antonio</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Meredith L Stensland, PhD</last_name>
      <phone>515 681 0459</phone>
      <email>stensland@uthscsa.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Don McGeary, PhD</last_name>
      <email>mcgeary@uthscsa.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>US Renal Care Dialysis Clinic</name>
        <address>
          <city>San Antonio</city>
          <state>Texas</state>
          <zip>78229</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Adrian Elorriaga, MD</last_name>
        <email>adrian.elorriaga@usrenalcare.com</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.usrenalcare.com/</url>
      <description>Study collaborate website (U.S. Renal Care, Inc.)</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The University of Texas Health Science Center at San Antonio</investigator_affiliation>
      <investigator_full_name>Meredith Stensland</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>treatment adherence</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Kidney Diseases</mesh_term>
      <mesh_term>Renal Insufficiency</mesh_term>
      <mesh_term>Kidney Failure, Chronic</mesh_term>
      <mesh_term>Chronic Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>De-identified data will be shared upon request when study data is analyzed and published in a peer review journal.</ipd_description>
    </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/NCT06030050
  org study id: 20230396HU
  nct id: NCT06030050
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to understand if and how an animal-assisted intervention
        [AAI] using therapy dogs can support hemodialysis [HD] patients' treatment adherence and
        enhance their well-being. The main objectives are:
  
          -  Objective 1: Determine if the AAI impacts patients' HD treatment adherence (primary
             outcome is number of unplanned missed treatments no due to hospitalization).
  
          -  Objective 2: Evaluate if the AAI impacts patients' psychosocial well-being (secondary
             outcomes are stress, pain, mood, QOL).
  
          -  Objective 3: Examine potential mechanistic biomarkers that underpin human-animal bonding
             (hormones tied to stress and bonding). (exploratory aim)
  
          -  Objective 4: Understand patients' subjective experiences of the AAI.
  
        Participants will be asked to engage in several research tasks, including:
  
          -  assessments
  
          -  therapy dog visits
  
          -  monthly blood draws
  
          -  focus group
  
        Researchers will compare how the treatment group (those who receive 2 dogs visits per week)
        and the control group (those who receive 0 dog visits per week) to see if the AAI impacts
        treatment adherence and psychosocial well-being.
  This study will take place in one outpatient dialysis clinic. The clinical trial will compare
        a standardized therapy dog interaction delivered twice weekly (based on pilot study outcomes
        detailed below) to usual care (e.g., no dog exposure) using a 1:1 randomized, 2-arm design.
        Subjective patient-reported outcomes [PRO] and routinely-tracked clinic data (e.g., missed
        visits) will be used. A total of 30 patients will be recruited then randomized 1:1 into 2
        arms: control group with 0 dog visits (n = 15) and intervention group with 2 dog visits per
        week for 20 weeks (n = 15). The AAI is designed to promote patient comfort, uplift mood, and
        provide an opportunity for socialization. The nature of the dog interaction involves several
        different components, including but not limited to: petting the dog, talking to the dog,
        watching the dog do tricks, conversing with the dog handler, and being prompted to discuss
        any fond memories/stories of their own personal experiences with human-animal interactions.
        Regarding duration, the dog visits average 10 minutes but will be allowed to vary, and length
        of dog visits will be tracked. Each team (dog handler + dog) will have an assigned unique ID
        so that variation in dog is controlled for. This study will utilize trained certified dog
        handlers to deliver the intervention from reputable local and national pet therapy
        organizations. All dogs have gone through extensive training and behavioral assessment, will
        provide proper documentation, liability insurance, and vaccinations. All study procedures
        take place in the clinic waiting room. Patient-reported outcomes (PRO)s will be collected as
        pre-post data (before and after dog visit or lobby-as-usual control condition). All PROs will
        be collected electronically on iPads using REDcap. Regarding treatment adherence data, the
        clinic routinely tracks missed appointments and will report these metrics directly to
        research team. Patients will complete assessments 2 times per week for a total of 20 weeks. A
        short demographic questionnaire will be administered once at the first study visit. Also,
        patients will also undergo a monthly blood-draw providing 3mL of blood 1 time a month at the
        same time as their standard of care blood draw. This will be bio-banked in a repository for
        later ELISA analyses, which will focus on hormones related to stress and bonding (e.g.,
        oxytocin, cortisol); this may provide insight into mechanistic biomarkers underpinning the
        human-animal bonding process. Lastly, qualitative focus groups with intervention group
        participants will be conducted post-trial to learn about their subjective experiences of the
        AAI.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Treatment adherence
  time frame: 20 weeks
  description: Number of unplanned missed hemodialysis treatment sessions not due to hospitalizations
  measure: Affective distress
  time frame: 20 weeks
  description: Anxiety & depression (PHQ-4). This is 4 items. Total score is determined by adding together the scores of each of the 4 items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score ≥3 for first 2 questions suggests anxiety. Total score ≥3 for last 2 questions suggests depression.
  measure: Pain unpleasantness
  time frame: 20 weeks
  description: Pain unpleasantness (Numeric Rating Scale 0-10) This is 1 item. higher score means worse pain.
  measure: Pain intensity
  time frame: 20 weeks
  description: Pain intensity (PROMIS-SF). This is 3 items, score range 3 - 15 (raw scores) , higher scores indicate worse pain.
  measure: Stress
  time frame: 20 weeks
  description: Subjective psychological stress (Stress symptom scale). 1 item, 5-point likert scale, higher score indicates greater stress.
  measure: Dog bonding
  time frame: 20 weeks
  description: Human Animal Bond Scale. Emotionality sub-scale (7 items). 5-pt likert scale. Higher scores indicate higher levels of bonding between human and animal.
  measure: Companionship
  time frame: 20 weeks
  description: Social togetherness (PROMIS-SF companionship). 4 items. 5-pt likert scale. Higher scores indicate higher levels of companionship.
  measure: Social Support
  time frame: 20 weeks
  description: Emotional support (PROMIS-SF Emotional support). 4 items. 5-pt likert scale. Higher scores indicate higher levels of support.
  measure: Perceived subjective Quality of life
  time frame: 20 weeks
  description: Perceived overall quality (Kemp QOL scale). 1 item. 7-pt likert scale, higher score indicates better perceived quality of life.
  arm group label: Treatment group
  arm group type: Experimental
  description: Intervention: Animal-assisted intervention (therapy dog visit) Frequency: 2 dog visits per week Duration: each visit is approx 10 mins long, study lasts 20 weeks
  arm group label: Control group
  arm group type: No Intervention
  description: Intervention: NONE - sit in waiting room like usual Frequency: 0 dog visits per week Duration: study lasts 20 weeks
  intervention type: Behavioral
  intervention name: Animal-assisted intervention
  description: The AAI is designed to promote patient comfort, uplift mood, and provide an opportunity for socialization. The nature of the dog interaction involves several different components, including but not limited to: petting the dog, talking to the dog, watching the dog do tricks, conversing with the dog handler, and being prompted to discuss any fond memories/stories of their own personal experiences with human-animal interactions. Therapy dogs are trained and certified animals who are leashed at all times and under direct care of their dog handler, NOT companion animals, personal pets, nor emotional support animals.
  arm group label: Treatment group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Meredith L Stensland, PhD
  role: Principal Investigator
  affiliation: The University of Texas Health Science Center at San Antonio
  last name: Meredith L Stensland, PhD
  phone: 515 681 0459
  email: stensland@uthscsa.edu
  last name: Don McGeary, PhD
  email: mcgeary@uthscsa.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  url: https://www.usrenalcare.com/
  description: Study collaborate website (U.S. Renal Care, Inc.)
  responsible party type: Principal Investigator
  investigator affiliation: The University of Texas Health Science Center at San Antonio
  investigator full name: Meredith Stensland
  investigator title: Assistant Professor
  mesh term: Kidney Diseases
  mesh term: Renal Insufficiency
  mesh term: Kidney Failure, Chronic
  mesh term: Chronic Pain
  sharing ipd: Yes
  ipd description: De-identified data will be shared upon request when study data is analyzed and published in a peer review journal.