Animal Assisted Intervention for Hemodialysis Outpatients
NCT06030050 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2023-10-06
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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