Clinical trial NCT06030050: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: End-Stage Kidney Disease
Chronic Kidney Failure
Chronic Pain
Keywords: treatment adherence
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: U.S. Renal Care, Inc.
First posted: 2023-09-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Treatment adherence
timeFrame: 20 weeks
Secondary outcomes:
measure: Affective distress
timeFrame: 20 weeks
measure: Pain unpleasantness
timeFrame: 20 weeks
measure: Pain intensity
timeFrame: 20 weeks
measure: Stress
timeFrame: 20 weeks
measure: Dog bonding
timeFrame: 20 weeks
measure: Companionship
timeFrame: 20 weeks
measure: Social Support
timeFrame: 20 weeks
measure: Perceived subjective Quality of life
timeFrame: 20 weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: US Renal Care Dialysis Clinic
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Meredith L Stensland, PhD
role: PRINCIPAL_INVESTIGATOR
References: