Animal Assisted Intervention for Hemodialysis Outpatients

• ClinicalTrials.gov Identifier: NCT06030050
• Recruitment Status: Withdrawn
• First Posted: September 8, 2023
• Last Update Posted: October 6, 2023
• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborator: U.S. Renal Care, Inc.
• Information provided by (Responsible Party): The University of Texas Health Science Center at San Antonio

Tracking Information

• First Submitted Date: August 31, 2023
• First Posted Date: September 8, 2023
• Last Update Posted Date: October 6, 2023
• Estimated Study Start Date: November 1, 2023
• Estimated Primary Completion Date: January 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 31, 2023)

Treatment adherence [ Time Frame: 20 weeks ]

Number of unplanned missed hemodialysis treatment sessions not due to hospitalizations

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 31, 2023)

• Affective distress [ Time Frame: 20 weeks ]
  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.
• Pain unpleasantness [ Time Frame: 20 weeks ]
  Pain unpleasantness (Numeric Rating Scale 0-10) This is 1 item. higher score means worse pain.
• Pain intensity [ Time Frame: 20 weeks ]
  Pain intensity (PROMIS-SF). This is 3 items, score range 3 - 15 (raw scores) , higher scores indicate worse pain.
• Stress [ Time Frame: 20 weeks ]
  Subjective psychological stress (Stress symptom scale). 1 item, 5-point likert scale, higher score indicates greater stress.
• Dog bonding [ Time Frame: 20 weeks ]
  Human Animal Bond Scale. Emotionality sub-scale (7 items). 5-pt likert scale. Higher scores indicate higher levels of bonding between human and animal.
• Companionship [ Time Frame: 20 weeks ]
  Social togetherness (PROMIS-SF companionship). 4 items. 5-pt likert scale. Higher scores indicate higher levels of companionship.
• Social Support [ Time Frame: 20 weeks ]
  Emotional support (PROMIS-SF Emotional support). 4 items. 5-pt likert scale. Higher scores indicate higher levels of support.
• Perceived subjective Quality of life [ Time Frame: 20 weeks ]
  Perceived overall quality (Kemp QOL scale). 1 item. 7-pt likert scale, higher score indicates better perceived quality of life.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Animal Assisted Intervention for Hemodialysis Outpatients
• Official Title: Animal Assisted Intervention for Hemodialysis Outpatients: A Mixed-method Randomized Controlled Trial for Treatment Adherence and Psychosocial Well-being

Brief Summary

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.

• Detailed Description: 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• End-Stage Kidney Disease
• Chronic Kidney Failure
• Chronic Pain

Intervention

Behavioral: Animal-assisted intervention

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.

Study Arms

• Experimental: Treatment group
  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
  Intervention: Behavioral: Animal-assisted intervention
• No Intervention: Control group
  Intervention: NONE - sit in waiting room like usual Frequency: 0 dog visits per week Duration: study lasts 20 weeks

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: October 4, 2023): 0
• Original Estimated Enrollment (submitted: August 31, 2023): 30
• Estimated Study Completion Date: February 2024
• Estimated Primary Completion Date: January 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• current HD patient
• aged 18+,
• English speaking, -≥2 missed HD treatments in the last 90 days.

Exclusion Criteria:

• not an HD patient currently
• aged younger than 18 years old
• lacks proficiency in English speaking and reading
• has only 1 or less missed HD treatments in the last 90 days.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06030050
• Other Study ID Numbers: 20230396HU
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: De-identified data will be shared upon request when study data is analyzed and published in a peer review journal.

• Current Responsible Party: The University of Texas Health Science Center at San Antonio
• Original Responsible Party: Meredith Stensland, The University of Texas Health Science Center at San Antonio, Assistant Professor
• Current Study Sponsor: The University of Texas Health Science Center at San Antonio
• Original Study Sponsor: Same as current
• Collaborators: U.S. Renal Care, Inc.

Investigators

• Principal Investigator: Meredith L Stensland, PhD; The University of Texas Health Science Center at San Antonio

• PRS Account: The University of Texas Health Science Center at San Antonio
• Verification Date: October 2023