Animal Assisted Intervention for Hemodialysis Outpatients

NCT06030050 | Withdrawn

• 1 other identifier: 20230396HU
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

treatment adherence

Outcome Measures

Primary Outcomes (1)

• Treatment adherence

  Number of unplanned missed hemodialysis treatment sessions not due to hospitalizations

  20 weeks

Secondary Outcomes (8)

• Affective distress

  20 weeks

• Pain unpleasantness

  20 weeks

• Pain intensity

  20 weeks

• Stress

  20 weeks

• Dog bonding

  20 weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Behavioral: Animal-assisted intervention

Control group

NO INTERVENTION

Intervention: NONE - sit in waiting room like usual Frequency: 0 dog visits per week Duration: study lasts 20 weeks

Interventions

Animal-assisted intervention BEHAVIORAL

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.

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• U.S. Renal Care, Inc.: collaborator

Study Sites (1)

US Renal Care Dialysis Clinic

San Antonio, Texas, 78229, United States

Location

Related Links

• Study collaborate website (U.S. Renal Care, Inc.)

MeSH Terms

Conditions

Kidney Failure, Chronic; Chronic Pain; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Health Behavior; Behavior

Study Officials

• Meredith L Stensland, PhD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 8, 2023
• Study Start: November 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2024
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)