- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06030050
Animal Assisted Intervention for Hemodialysis Outpatients
Animal Assisted Intervention for Hemodialysis Outpatients: A Mixed-method Randomized Controlled Trial for Treatment Adherence and Psychosocial Well-being
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78229
- US Renal Care Dialysis Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment group
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
|
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.
|
No Intervention: Control group
Intervention: NONE - sit in waiting room like usual Frequency: 0 dog visits per week Duration: study lasts 20 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment adherence
Time Frame: 20 weeks
|
Number of unplanned missed hemodialysis treatment sessions not due to hospitalizations
|
20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Affective distress
Time Frame: 20 weeks
|
Anxiety & depression (PHQ-4).
This is 4 items.
Total score is determined by adding together the scores of each of the 4 items.
Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12).
Total score ≥3 for first 2 questions suggests anxiety.
Total score ≥3 for last 2 questions suggests depression.
|
20 weeks
|
Pain unpleasantness
Time Frame: 20 weeks
|
Pain unpleasantness (Numeric Rating Scale 0-10) This is 1 item.
higher score means worse pain.
|
20 weeks
|
Pain intensity
Time Frame: 20 weeks
|
Pain intensity (PROMIS-SF).
This is 3 items, score range 3 - 15 (raw scores) , higher scores indicate worse pain.
|
20 weeks
|
Stress
Time Frame: 20 weeks
|
Subjective psychological stress (Stress symptom scale). 1 item, 5-point likert scale, higher score indicates greater stress.
|
20 weeks
|
Dog bonding
Time Frame: 20 weeks
|
Human Animal Bond Scale.
Emotionality sub-scale (7 items).
5-pt likert scale.
Higher scores indicate higher levels of bonding between human and animal.
|
20 weeks
|
Companionship
Time Frame: 20 weeks
|
Social togetherness (PROMIS-SF companionship).
4 items.
5-pt likert scale.
Higher scores indicate higher levels of companionship.
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20 weeks
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Social Support
Time Frame: 20 weeks
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Emotional support (PROMIS-SF Emotional support).
4 items.
5-pt likert scale.
Higher scores indicate higher levels of support.
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20 weeks
|
Perceived subjective Quality of life
Time Frame: 20 weeks
|
Perceived overall quality (Kemp QOL scale). 1 item.
7-pt likert scale, higher score indicates better perceived quality of life.
|
20 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Meredith L Stensland, PhD, The University of Texas Health Science Center at San Antonio
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Urologic Diseases
- Pain
- Neurologic Manifestations
- Disease Attributes
- Renal Insufficiency, Chronic
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Chronic Pain
- Kidney Failure, Chronic
- Renal Insufficiency
Other Study ID Numbers
- 20230396HU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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