Animal Assisted Intervention for Hemodialysis Outpatients
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ClinicalTrials.gov Identifier: NCT06030050 |
Recruitment Status :
Withdrawn
(The study was not feasible to conduct.)
First Posted : September 8, 2023
Last Update Posted : October 6, 2023
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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.
Condition or disease | Intervention/treatment | Phase |
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End-Stage Kidney Disease Chronic Kidney Failure Chronic Pain | Behavioral: Animal-assisted intervention | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Animal Assisted Intervention for Hemodialysis Outpatients: A Mixed-method Randomized Controlled Trial for Treatment Adherence and Psychosocial Well-being |
Estimated Study Start Date : | November 1, 2023 |
Estimated Primary Completion Date : | January 2024 |
Estimated Study Completion Date : | February 2024 |
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
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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. |
No Intervention: Control group
Intervention: NONE - sit in waiting room like usual Frequency: 0 dog visits per week Duration: study lasts 20 weeks
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- Treatment adherence [ Time Frame: 20 weeks ]Number of unplanned missed hemodialysis treatment sessions not due to hospitalizations
- 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.
- Pain unpleasantness [ Time Frame: 20 weeks ]Pain unpleasantness (Numeric Rating Scale 0-10) This is 1 item. higher score means worse pain.
- 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.
- Stress [ Time Frame: 20 weeks ]Subjective psychological stress (Stress symptom scale). 1 item, 5-point likert scale, higher score indicates greater stress.
- 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.
- Companionship [ Time Frame: 20 weeks ]Social togetherness (PROMIS-SF companionship). 4 items. 5-pt likert scale. Higher scores indicate higher levels of companionship.
- Social Support [ Time Frame: 20 weeks ]Emotional support (PROMIS-SF Emotional support). 4 items. 5-pt likert scale. Higher scores indicate higher levels of support.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06030050
United States, Texas | |
US Renal Care Dialysis Clinic | |
San Antonio, Texas, United States, 78229 |
Principal Investigator: | Meredith L Stensland, PhD | The University of Texas Health Science Center at San Antonio |
Responsible Party: | The University of Texas Health Science Center at San Antonio |
ClinicalTrials.gov Identifier: | NCT06030050 |
Other Study ID Numbers: |
20230396HU |
First Posted: | September 8, 2023 Key Record Dates |
Last Update Posted: | October 6, 2023 |
Last Verified: | October 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | De-identified data will be shared upon request when study data is analyzed and published in a peer review journal. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
treatment adherence |
Kidney Diseases Renal Insufficiency Kidney Failure, Chronic Chronic Pain Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases |
Male Urogenital Diseases Pain Neurologic Manifestations Renal Insufficiency, Chronic Chronic Disease Disease Attributes Pathologic Processes |