Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-27 @ 3:58 PM
Study NCT ID:
NCT06030050
Status:
WITHDRAWN
Last Update Posted:
2023-10-06
First Post:
2023-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Animal Assisted Intervention for Hemodialysis Outpatients
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
Study Overview
Official Title:
Animal Assisted Intervention for Hemodialysis Outpatients: A Mixed-method Randomized Controlled Trial for Treatment Adherence and Psychosocial Well-being
Status:
WITHDRAWN
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was not feasible to conduct.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: