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Study concluded prematurly
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The purpose of this study is to evaluate use of service dogs for individuals who have been diagnosed with Post Traumatic Stress Disorder (PTSD). Objectives include: (1) assess the impact service dogs have on the mental health and quality of life of Veterans; (2) to provide recommendations to the VA to serve as guidance in providing service dogs to Veterans; and (3) To determine cost associated with total health care utilization and mental health care utilization among Veterans with PTSD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Service Dogs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Service Dogs | Other | Service dogs will be trained to help Veterans with PTSD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mental Health Outcomes | Mental Health Outcomes are defined by the following measures: PCL-S - PTSD symptoms | 3,6,9,12,18 and 24 months after receipt of service dog |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie McGovern, RN | James A. Haley Veterans' Hospital, Tampa, FL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James A. Haley Veterans' Hospital, Tampa, FL | Tampa | Florida | 33612 | United States |
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Veterans were recruited prior to receipt of ServiceDog and given questionnaires to complete. They were followed and questionnaires completed every 3 months until receipt of Service Dog.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | Service Dogs Service Dogs: Service dogs will be trained to help Veterans with PTSD |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Service Dog | Veterans who received a service dog |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mental Health Outcomes | Mental Health Outcomes are defined by the following measures: PCL-S - PTSD symptoms | No valid data to report. | Posted | 3,6,9,12,18 and 24 months after receipt of service dog |
|
|
AE data were collected from 7/1/2011 - 1/31/2017, 5 years, 7 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Service Dog | Veterans who received a service dog | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subject death due to car accident | Injury, poisoning and procedural complications | Non-systematic Assessment | Unknown what specific injuries caused the subject's death in the accident |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Subject complaint about the veterinarian on the study team | Social circumstances | Non-systematic Assessment |
Study was terminated but a subsequent multisite clinical trial (NCT02039843) was completed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie McGovern | James A Haley Veterans Hospital | 813-558-3964 | stephanie.mcgovern@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 26, 2014 | Apr 20, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 60 |
| 10 |
| 60 |
| 12 |
| 60 |
|
| Subject's child bitten by service dog | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Child had bruising, no medical attention required. |
|
| Subject paired with a service dog suffering from health problems. | Social circumstances | Non-systematic Assessment |
|
| Subject fell down stairs at home and was hospitalized with a fractured ankle | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Subject tripped over walker at home and sustained minor injuries - was treated at home by spouse | Skin and subcutaneous tissue disorders | Non-systematic Assessment | skin tear and bruising occured |
|
| Subject twisted their ankle while on a walk and called 911. Was transported to the ER | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Given medication and crutches in the ER and sent home |
|
| Subject hospitalized for removal of kidney related to cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Service dog euthanized due to inoperable spinal tumor | Social circumstances | Non-systematic Assessment |
|
| Subject hospitalized | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Subject "not feeling right" and called 911. Hospitalized with respiratory difficulty. Monitored, treated and released after short inpatient stay. |
|
| Subject and service dog attacked by a dog | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Subject received minor puncture wound to finger and dog had injuries to his side. Both received outpatient medical treatment and released |
|
| Subject divulged her phone number on a blog and received harassing calls | Social circumstances | Non-systematic Assessment |
|
| Subject's child nipped by service dog | Social circumstances | Non-systematic Assessment | No medical attention required |
|
| Subject's service dog died unexpectedly | Social circumstances | Non-systematic Assessment |
|
| Subject's PHI sent to unsecure fax machine | Social circumstances | Non-systematic Assessment |
|
| Financial exchange between subject and vendor | Social circumstances | Non-systematic Assessment | Subject gave money to vendor to buy dog food and other items for dogs. |
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| Vendor threatened subject with lawsuit over possession of puppy | Social circumstances | Non-systematic Assessment |
|
| Vendor paired dog with subject prior to enrollement in study | Social circumstances | Non-systematic Assessment |
|
| Subject's finger caught in service dog's leash and was injured | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Subject upset that OIG was contacting him, felt harassed | Social circumstances | Non-systematic Assessment |
|
| Veteran who withdrew from study upset about lack of insurance coverage | Social circumstances | Non-systematic Assessment |
|
| Wife of subject shared withdrawal letter with others | Social circumstances | Non-systematic Assessment |
|
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