Trial Outcomes & Findings for Service Dogs for Veterans With PTSD (NCT NCT01329341)
NCT ID: NCT01329341
Last Updated: 2021-07-09
Results Overview
Mental Health Outcomes are defined by the following measures: PCL-S - PTSD symptoms
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
3,6,9,12,18 and 24 months after receipt of service dog
Results posted on
2021-07-09
Participant Flow
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.
Participant milestones
| Measure |
Arm 1
Service Dogs
Service Dogs: Service dogs will be trained to help Veterans with PTSD
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
44
|
Reasons for withdrawal
| Measure |
Arm 1
Service Dogs
Service Dogs: Service dogs will be trained to help Veterans with PTSD
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
44
|
Baseline Characteristics
Service Dogs for Veterans With PTSD
Baseline characteristics by cohort
| Measure |
Service Dog
n=60 Participants
Veterans who received a service dog
|
|---|---|
|
Age, Continuous
|
50.8 years
STANDARD_DEVIATION 15.2 • n=39 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 3,6,9,12,18 and 24 months after receipt of service dogPopulation: No valid data to report.
Mental Health Outcomes are defined by the following measures: PCL-S - PTSD symptoms
Outcome measures
Outcome data not reported
Adverse Events
Service Dog
Serious events: 10 serious events
Other events: 12 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Service Dog
n=60 participants at risk
Veterans who received a service dog
|
|---|---|
|
Injury, poisoning and procedural complications
Subject death due to car accident
|
1.7%
1/60 • Number of events 1 • AE data were collected from 7/1/2011 - 1/31/2017, 5 years, 7 months
|
|
Skin and subcutaneous tissue disorders
Subject's child bitten by service dog
|
1.7%
1/60 • Number of events 1 • AE data were collected from 7/1/2011 - 1/31/2017, 5 years, 7 months
|
|
Social circumstances
Subject paired with a service dog suffering from health problems.
|
1.7%
1/60 • Number of events 1 • AE data were collected from 7/1/2011 - 1/31/2017, 5 years, 7 months
|
|
Musculoskeletal and connective tissue disorders
Subject fell down stairs at home and was hospitalized with a fractured ankle
|
1.7%
1/60 • Number of events 1 • AE data were collected from 7/1/2011 - 1/31/2017, 5 years, 7 months
|
|
Skin and subcutaneous tissue disorders
Subject tripped over walker at home and sustained minor injuries - was treated at home by spouse
|
1.7%
1/60 • Number of events 1 • AE data were collected from 7/1/2011 - 1/31/2017, 5 years, 7 months
|
|
Musculoskeletal and connective tissue disorders
Subject twisted their ankle while on a walk and called 911. Was transported to the ER
|
1.7%
1/60 • Number of events 1 • AE data were collected from 7/1/2011 - 1/31/2017, 5 years, 7 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Subject hospitalized for removal of kidney related to cancer
|
1.7%
1/60 • Number of events 1 • AE data were collected from 7/1/2011 - 1/31/2017, 5 years, 7 months
|
|
Social circumstances
Service dog euthanized due to inoperable spinal tumor
|
1.7%
1/60 • Number of events 1 • AE data were collected from 7/1/2011 - 1/31/2017, 5 years, 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Subject hospitalized
|
1.7%
1/60 • Number of events 1 • AE data were collected from 7/1/2011 - 1/31/2017, 5 years, 7 months
|
|
Skin and subcutaneous tissue disorders
Subject and service dog attacked by a dog
|
1.7%
1/60 • Number of events 1 • AE data were collected from 7/1/2011 - 1/31/2017, 5 years, 7 months
|
Other adverse events
| Measure |
Service Dog
n=60 participants at risk
Veterans who received a service dog
|
|---|---|
|
Social circumstances
Subject complaint about the veterinarian on the study team
|
1.7%
1/60 • Number of events 1 • AE data were collected from 7/1/2011 - 1/31/2017, 5 years, 7 months
|
|
Social circumstances
Subject divulged her phone number on a blog and received harassing calls
|
1.7%
1/60 • Number of events 1 • AE data were collected from 7/1/2011 - 1/31/2017, 5 years, 7 months
|
|
Social circumstances
Subject's child nipped by service dog
|
1.7%
1/60 • Number of events 1 • AE data were collected from 7/1/2011 - 1/31/2017, 5 years, 7 months
|
|
Social circumstances
Subject's service dog died unexpectedly
|
1.7%
1/60 • Number of events 1 • AE data were collected from 7/1/2011 - 1/31/2017, 5 years, 7 months
|
|
Social circumstances
Subject's PHI sent to unsecure fax machine
|
1.7%
1/60 • Number of events 1 • AE data were collected from 7/1/2011 - 1/31/2017, 5 years, 7 months
|
|
Social circumstances
Financial exchange between subject and vendor
|
1.7%
1/60 • Number of events 1 • AE data were collected from 7/1/2011 - 1/31/2017, 5 years, 7 months
|
|
Social circumstances
Vendor threatened subject with lawsuit over possession of puppy
|
1.7%
1/60 • Number of events 1 • AE data were collected from 7/1/2011 - 1/31/2017, 5 years, 7 months
|
|
Social circumstances
Vendor paired dog with subject prior to enrollement in study
|
1.7%
1/60 • Number of events 1 • AE data were collected from 7/1/2011 - 1/31/2017, 5 years, 7 months
|
|
Musculoskeletal and connective tissue disorders
Subject's finger caught in service dog's leash and was injured
|
1.7%
1/60 • Number of events 1 • AE data were collected from 7/1/2011 - 1/31/2017, 5 years, 7 months
|
|
Social circumstances
Subject upset that OIG was contacting him, felt harassed
|
1.7%
1/60 • Number of events 1 • AE data were collected from 7/1/2011 - 1/31/2017, 5 years, 7 months
|
|
Social circumstances
Veteran who withdrew from study upset about lack of insurance coverage
|
1.7%
1/60 • Number of events 1 • AE data were collected from 7/1/2011 - 1/31/2017, 5 years, 7 months
|
|
Social circumstances
Wife of subject shared withdrawal letter with others
|
1.7%
1/60 • Number of events 1 • AE data were collected from 7/1/2011 - 1/31/2017, 5 years, 7 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place