Traumatic Brain InjuryAAT/TBINCT05217030
Efficacy of Animal Assisted Therapy in the Treatment of Patients With Traumatic Brain Injury
A study testing Animal assisted therapy in people with Traumatic Brain Injury, run by Inova Health Care Services at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Animal assisted therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2014to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not meeting inclusion criteria (n=58)
- Declined to participate (n=21)
- No next of kin for consent (n=147)
- Unsurvivable injury (n=83)
Trial locations and contacts
1 site in 1 country.
United States1 site
Inova Fairfax Medical Campus
Fairfax, Virginia, 22042
About this study
Official title: Efficacy of Animal Assisted Therapy in the Treatment of Patients With Traumatic Brain Injury (AAT/TBI)
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).
Read the 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Animal assisted therapy
- Keywords
- Critical Care, TBI, Animal Assisted Therapy
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal assisted therapyOther
Also called AAT
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
| Study group | Role | What they receive |
|---|---|---|
| Animal Assisted Therapy | Experimental | This group of patients with traumatic brain injury received AAT throughout the acute care hospitalization Receives: Other: Animal assisted therapy |
| Control | No intervention | This group of patients with traumatic brain injury did not receive AAT throughout the acute care hospitalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start30 Jun 2014
- Primary completion30 Nov 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups of patients had comparison of measurements-one group received AAT; one group did not
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leslie Horton, Inova Health Care Services
- Investigators
- Leslie Horton, RN, MBA, CCRN, Principal investigator, Inova Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217030
- Sponsor's protocol ID
- 12-1216
- Acronym
- AAT/TBI
- Status last verified
- Feb 2022
- First submitted
- 6 Jan 2022
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brain Trauma Foundation. (2021). It Can Happen Anywhere, Anytime, to Anyone. Retrieved July 2021, Brain_Trauma_Foundation.pdf: http://braintrauma.org
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.
PubMed 32339483Javali 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.
PubMed 31086450Murthy 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.
PubMed 25998315Pet Partners. Pet Partners. Retrieved from https://petpartners.org. 2021
Osterhoudt, S. R. Animal Assisted Therapy: Improving Patient Outcomes in the ICU. Excelsior College, School of Nursing. 2018
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.
PubMed 21632591Hedrin, 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-
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.
PubMed 21263346Cole 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.
PubMed 11040560Aldaghlas, 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Animal Assisted Therapy in the Treatment of Patients With Traumatic Brain Injury (AAT/TBI)
- ClinicalTrials.gov ID
- NCT05217030
- Acronym / sponsor ID
- AAT/TBI / 12-1216
- Conditions
- Traumatic Brain Injury
- Keywords
- Critical Care, TBI, Animal Assisted Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- 30 Jun 2014 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups of patients had comparison of measurements-one group received AAT; one group did not
| Arm | Type | Receives |
|---|---|---|
| Animal Assisted Therapy | Experimental | Other: Animal assisted therapyThis group of patients with traumatic brain injury received AAT throughout the acute care hospitalization |
| Control | No intervention | –This group of patients with traumatic brain injury did not receive AAT throughout the acute care hospitalization |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Not meeting inclusion criteria (n=58)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animal assisted therapyAlso: AATPatients 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 | Other | Animal Assisted Therapy |
Primary outcome
Glasgow Coma Scale
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- BackgroundBrain Trauma Foundation. (2021). It Can Happen Anywhere, Anytime, to Anyone. Retrieved July 2021, Brain_Trauma_Foundation.pdf: http://braintrauma.org
- Background: PubMed 32339483Lo 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.
- Background: PubMed 31086450Javali 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.
- Background: PubMed 25998315Murthy 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.
- BackgroundPet Partners. Pet Partners. Retrieved from https://petpartners.org. 2021
- BackgroundOsterhoudt, S. R. Animal Assisted Therapy: Improving Patient Outcomes in the ICU. Excelsior College, School of Nursing. 2018
- Background: PubMed 21632591Tracy 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.
- BackgroundHedrin, 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-
- Background: PubMed 21263346Abate 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.
- Background: PubMed 11040560Cole 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.
- BackgroundAldaghlas, 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie Horton, RN, MBA, CCRN principal investigator
Inova Health Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animal assisted therapy in people with Traumatic Brain Injury, run by Inova Health Care Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Coma Scale (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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05217030, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022.