Animal Assisted Intervention for Hemodialysis Outpatients

NCT06030050 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-10-06

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • U.S. Renal Care, Inc.

    collaborator UNKNOWN
  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Meredith L Stensland, PhD · The University of Texas Health Science Center at San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2024-01-31
Completion
2024-02-29

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06030050 on ClinicalTrials.gov