Efficacy of Animal Assisted Therapy in the Treatment of Patients With Traumatic Brain Injury (AAT/TBI)
Primary Purpose
Traumatic Brain Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Animal assisted therapy
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Critical Care, TBI, Animal Assisted Therapy
Eligibility Criteria
Inclusion Criteria:
- Admitted to Trauma ED with GCS < 10 due to Traumatic Brain Injury via head CT scan and/or head MRI
- Primary language is Spanish or English
- Free of Infection Precautions
- No canine allergies or fears
- Consent to Study Obtainable
Exclusion Criteria:
Not meeting inclusion criteria (n=58)
- Declined to participate (n=21)
- No next of kin for consent (n=147)
- Unsurvivable injury (n=83)
Sites / Locations
- Inova Fairfax Medical Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Animal Assisted Therapy
Control
Arm Description
This group of patients with traumatic brain injury received AAT throughout the acute care hospitalization
This group of patients with traumatic brain injury did not receive AAT throughout the acute care hospitalization
Outcomes
Primary Outcome Measures
Glasgow Coma Scale
standard measure in acute care for level of consciousness with scale of 3 -15 and 15 being the higher level of consciousness
Rancho Los Amigo Scale
standard measure in acute and rehab care for level of consciousness, and for purposes of this study, were measured from 1 to 7 with 7 being reflective of the higher level of consciousness
Level of Commands
ability to follow 3-step commands and is used for measure level of cognition with 0 being the lowest and 3 being the score that reflects higher level of consiousness
Secondary Outcome Measures
Full Information
NCT ID
NCT05217030
First Posted
January 6, 2022
Last Updated
February 18, 2022
Sponsor
Inova Health Care Services
1. Study Identification
Unique Protocol Identification Number
NCT05217030
Brief Title
Efficacy of Animal Assisted Therapy in the Treatment of Patients With Traumatic Brain Injury
Acronym
AAT/TBI
Official Title
Efficacy of Animal Assisted Therapy in the Treatment of Patients With Traumatic Brain Injury (AAT/TBI)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 30, 2014 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inova Health Care Services
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients admitted to the ED with moderate to severe traumatic brain injury defined by GCS less than or equal to 10 and confirmed by head CT scan or MRI were randomized into 2 groups: one receiving animal assisted therapy (AAT) and one not receiving animal assisted therapy. Efficacy of AAT was measured by patient's progression in the Glasgow Coma Scale (GCS), Rancho Los Amigos Scale (RLAS), and ability to follow multi-step commands (LoCmds).
Detailed Description
In this Level 3 prospective, randomized case control basic research study, investigators compared 2 groups, randomly assigned: patients receiving AAT during their hospital stay and those patients receiving usual care. Investigators recruited adult patients admitted to the TICU with a severe or moderate TBI; patients' legally authorized representatives provided consent for patients to be randomized into an intervention or control group. Patients were randomized to the intervention or control group in a 1:1 ratio; the randomization schedule was generated in advance by the study biostatistician utilizing a permuted block method with block sizes of 2 or 4. Study subjects' assigned groups were indicated on paper in a sealed envelope that was opened by the researchers upon receipt of signed informed consent form.
Investigators hypothesized the subjects in the intervention group would achieve higher elevation in Glasgow Coma Scale (GCS), Ranchos Los Amigos Scale (RLAS), and ability to follow commands than those in the control group. GCS, RLAS, and Levels of Command (LOCmd) scores were recorded by the bedside nurse for enrolled patients within 24 hours of consent. LOCmds were determined by the number of commands a patient could follow without prompting in between the commands. Subjects unable to follow any commands scored "0"; those able to follow one command scored "1," and so on, up to 3 commands without prompting. Intervention patients then received AAT with a dog, followed by the collection of post-intervention scores. The bedside RN assisted the handler in placing the dog onto the patient's bed and the patient was informed the dog was present. The patient's hand was placed on the dog and then the patient was instructed to open eyes and/or follow commands. The bedside RN assessed and the recorded the patient's responses before and after each AAI. Control patients' second set of scores were recorded after a researcher sat in the room without engaging the patient. The bedside RN assessed and recorded the patient before and after each control intervention. AAT and control activities, with associated data collection,continued every Monday, Wednesday, and Friday following initial measurements. Subjects remained enrolled in the study through discharge, or until the subject was recorded at RLAS 7, or until hospitalized over 28 days. Patients discharged from the study, but remaining in the hospital, were able to continue receiving AAT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Critical Care, TBI, Animal Assisted Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups of patients had comparison of measurements-one group received AAT; one group did not
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Animal Assisted Therapy
Arm Type
Experimental
Arm Description
This group of patients with traumatic brain injury received AAT throughout the acute care hospitalization
Arm Title
Control
Arm Type
No Intervention
Arm Description
This group of patients with traumatic brain injury did not receive AAT throughout the acute care hospitalization
Intervention Type
Other
Intervention Name(s)
Animal assisted therapy
Other Intervention Name(s)
AAT
Intervention Description
Patients in AAT group had handler place dog on bed and patient's hand was placed on dog. Bedside RN measured GCS, RLAS, LoCmds before and after intervention
Primary Outcome Measure Information:
Title
Glasgow Coma Scale
Description
standard measure in acute care for level of consciousness with scale of 3 -15 and 15 being the higher level of consciousness
Time Frame
measuring the change before and after each intervention while in study until hospitalized for a period of 28 days or reached a level of rancho los amigos scale of 7
Title
Rancho Los Amigo Scale
Description
standard measure in acute and rehab care for level of consciousness, and for purposes of this study, were measured from 1 to 7 with 7 being reflective of the higher level of consciousness
Time Frame
measuring the change before and after each intervention while in study until hospitalized for a period of 28 days or reached a level of rancho los amigos scale of 7
Title
Level of Commands
Description
ability to follow 3-step commands and is used for measure level of cognition with 0 being the lowest and 3 being the score that reflects higher level of consiousness
Time Frame
measuring the change before and after each intervention while in study until hospitalized for a period of 28 days or reached a level of rancho los amigos scale of 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Admitted to Trauma ED with GCS < 10 due to Traumatic Brain Injury via head CT scan and/or head MRI
Primary language is Spanish or English
Free of Infection Precautions
No canine allergies or fears
Consent to Study Obtainable
Exclusion Criteria:
Not meeting inclusion criteria (n=58)
Declined to participate (n=21)
No next of kin for consent (n=147)
Unsurvivable injury (n=83)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie Horton, RN, MBA, CCRN
Organizational Affiliation
Inova Health Systems
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inova Fairfax Medical Campus
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Brain Trauma Foundation. (2021). It Can Happen Anywhere, Anytime, to Anyone. Retrieved July 2021, Brain_Trauma_Foundation.pdf: http://braintrauma.org
Results Reference
background
PubMed Identifier
32339483
Citation
Lo J, Chan L, Flynn S. A Systematic Review of the Incidence, Prevalence, Costs, and Activity and Work Limitations of Amputation, Osteoarthritis, Rheumatoid Arthritis, Back Pain, Multiple Sclerosis, Spinal Cord Injury, Stroke, and Traumatic Brain Injury in the United States: A 2019 Update. Arch Phys Med Rehabil. 2021 Jan;102(1):115-131. doi: 10.1016/j.apmr.2020.04.001. Epub 2020 Apr 24.
Results Reference
background
PubMed Identifier
31086450
Citation
Javali RH, Krishnamoorthy, Patil A, Srinivasarangan M, Suraj, Sriharsha. Comparison of Injury Severity Score, New Injury Severity Score, Revised Trauma Score and Trauma and Injury Severity Score for Mortality Prediction in Elderly Trauma Patients. Indian J Crit Care Med. 2019 Feb;23(2):73-77. doi: 10.5005/jp-journals-10071-23120.
Results Reference
background
PubMed Identifier
25998315
Citation
Murthy R, Bearman G, Brown S, Bryant K, Chinn R, Hewlett A, George BG, Goldstein EJ, Holzmann-Pazgal G, Rupp ME, Wiemken T, Weese JS, Weber DJ. Animals in healthcare facilities: recommendations to minimize potential risks. Infect Control Hosp Epidemiol. 2015 May;36(5):495-516. doi: 10.1017/ice.2015.15. No abstract available.
Results Reference
background
Citation
Pet Partners. Pet Partners. Retrieved from https://petpartners.org. 2021
Results Reference
background
Citation
Osterhoudt, S. R. Animal Assisted Therapy: Improving Patient Outcomes in the ICU. Excelsior College, School of Nursing. 2018
Results Reference
background
PubMed Identifier
21632591
Citation
Tracy MF, Chlan L. Nonpharmacological interventions to manage common symptoms in patients receiving mechanical ventilation. Crit Care Nurse. 2011 Jun;31(3):19-28. doi: 10.4037/ccn2011653.
Results Reference
background
Citation
Hedrin, M. (2018, 2). Therapy Dogs May Unlock Health Benefits for Patients in Hospital ICUs. Retrieved August 2021, from John Hopkins University: https://hub.jhu.edu/2018/02/12/therapy-dogs-could-help-icu-patients-
Results Reference
background
PubMed Identifier
21263346
Citation
Abate SV, Zucconi M, Boxer BA. Impact of canine-assisted ambulation on hospitalized chronic heart failure patients' ambulation outcomes and satisfaction: a pilot study. J Cardiovasc Nurs. 2011 May-Jun;26(3):224-30. doi: 10.1097/JCN.0b013e3182010bd6.
Results Reference
background
PubMed Identifier
11040560
Citation
Cole KM, Gawlinski A. Animal-assisted therapy: the human-animal bond. AACN Clin Issues. 2000 Feb;11(1):139-49. doi: 10.1097/00044067-200002000-00015.
Results Reference
background
Citation
Aldaghlas, Tayseer. Burke, Christine. Chang, Yung-Fu. Horton, Leslie. Rizzo, Anne. Richmond, Robyn. Schmidt, Keilla. To Pet or Not: Canine Assisted Therapy and the Risk of Clostridium Difficile. International Conference on Healthcare-Associated Infections. Atlanta, Ga: SHEA/APIC. March 19, 2010. https://shea.confex.com/shea/2010/webprogram/Paper2497.html
Results Reference
background
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Efficacy of Animal Assisted Therapy in the Treatment of Patients With Traumatic Brain Injury
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