Spinal Cord Injuries
Conditions
Keywords
Spinal Cord Injuries, Quality of Life
Brief summary
The field of spinal cord injury rehabilitation medicine lacks a reliable, patient reported, health-related quality of life measurement tool. The National Institute of Health has provided funding to develop a spinal cord injury-specific, quality of life survey tool in non-Veterans with spinal cord injury called the spinal cord injury-quality of life (SCI-QOL). This quality of life survey asks questions regarding physical/medical, emotional, and social health as it relates to individuals with spinal cord injury. The purpose of this study is to include a Veteran population in the making of the quality of life survey. Each participant will be asked to complete a packet of quality of life questions. Participants will be given the opportunity to take the survey a second time, either 7-14 days or 5-7 months after the first survey. Taking the survey twice will allow the research team to test the reliability of the survey. Comparing the SCI-QOL with other legacy measures will allow the investigators to test the validity of the survey. Additionally, the investigators will be testing the SCI-QOL between Veterans and non-Veterans with SCI to determine if there are differences in their self-reported quality of life. This study will be recruiting participants at the James J. Peters Veterans Affairs Medical Center, Bronx, New York and the James A. Haley Veterans Affairs Hospital, Tampa, Florida.
Interventions
None listed
Sponsors
VA Office of Research and Development
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Male and female Veterans with traumatic spinal cord injury * At least 18 years old * Persons judged by their primary care doctor to be competent * Able to read * Fluent in English.
Exclusion criteria
* Veterans with non-traumatic spinal cord injury (non-traumatic is defined as any injury from a chronic condition that resulted in decline of function due to the paralysis. These conditions include, but are not limited to: multiple sclerosis, arteriole-venous malformation, nerve impingement syndromes, congenital birth defects, or other) * Diagnosis of a cognitive impairment (in the clinical chart) such that it limit the subject's ability to read, understand, and respond to statements about quality of life * Not fluent in English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SCI-QoL Independence | Baseline | Average score on a questionnaire about level of independence. The minimum score on the scale is 24.6 and the maximum is 68.9. Fifty is the average score. Values below 50 indicate a worse outcome. Values above 50 represent a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SCI-QoL Ability to Participate in Social Roles and Activities | Baseline | Average score on a SCI-QoL Ability to Participate in Social Roles and Activities scale. The minimum score on the scale is 25.1 and the maximum is 61.1. A higher score represents better functioning (more ability to participate in social roles and activities). |
| SCI-QoL Anxiety | Baseline | Average score on SCI-QoL Anxiety. The minimum score on the scale is 36.3 and the maximum is 84.2. A higher score represents more anxiety (worse functioning). A lower score represents less anxiety (better functioning). |
| SCI-QoL Bowel Management Difficulties | Baseline | Average score on SCI-QoL Bowel Management Difficulties. The minimum score on the scale is 39.2 and the maximum is 76.3. A higher score represents more bowel management difficulties (worse functioning). A lower score represents fewer bowel management difficulties (better functioning). |
| SCI-QoL Bladder Management Difficulties | Baseline | Average score on SCI-QoL Bladder Management Difficulties. The minimum score on the scale is 39.7 and the maximum is 76.8. A higher score represents more bladder management difficulties (worse functioning). A lower score represents fewer bladder management difficulties (better functioning). |
| SCI-QoL Depression | Baseline | Average score on SCI-QoL Depression. The minimum score on the scale is 38.3 and the maximum is 81.9. A higher score represents more depression (worse functioning). A lower score represents less depression (better functioning). |
| SCI-QoL Pain Behavior | Baseline | Average score on SCI-QoL Pain Behavior. The minimum score on the scale is 38.2 and the maximum is 76.1. A higher score represents more pain behavior (worse functioning). A lower score represents less pain behavior (better functioning). |
| SCI-QoL Positive Affect and Well-being | Baseline | Average score on SCI-QoL Positive Affect and Well-being. The minimum score on the scale is 26.7 and the maximum is 68.6. A higher score represents more positive affect and well-being (better functioning). |
| SCI-QoL Resilience | Baseline | Average score on SCI-QoL Resilience. The minimum score on the scale is 16.4 and the maximum is 66.4. A higher score represents more resilience (better functioning). |
| SCI-QoL Satisfaction With Social Roles and Activities | Baseline | Average score on SCI-QoL Satisfaction with Social Roles and Activities. The minimum score on the scale is 28.3 and the maximum is 60.5. A higher score represents more satisfaction with social roles and activities (better functioning). |
| SCI-QoL Stigma | Baseline | Average score on SCI-QoL Stigma. The minimum score on the scale is 37.8 and the maximum is 77.3. A higher score represents more stigma (worse functioning). A lower score represents less stigma (better functioning). |
| SCI-QoL Trauma | Baseline | Average score on SCI-QoL Trauma. The minimum score on the scale is 38.4 and the maximum is 85.2. A higher score represents more trauma (worse functioning). A lower score represents less trauma (better functioning). |
| SCI-QoL Pain Interference | Baseline | Average score on SCI-QoL Pain Interference. The minimum score on the scale is 40.2 and the maximum is 79.7. A higher score represents more pain interference (worse functioning). A lower score represents less anxiety (better functioning). |
Other
| Measure | Time frame | Description |
|---|---|---|
| SCI-QoL Grief Loss | Baseline | Average score on SCI-QoL Grief Loss. The minimum score on the scale is 30.9 and the maximum is 76.1. A higher score represents more grief/loss (worse functioning). A lower score represents less grief/loss (better functioning). |
Countries
United States
Participant flow
Recruitment details
Participants recruited from SCI Clinics at the James J. Peters Veterans Affairs Medical Center, Bronx, New York and the James A. Haley Veterans Hospital, Tampa, Florida. 284 participants signed consent. 248 participants completed the Quality of Life questionnaires.
Participants by arm
| Arm | Count |
|---|---|
| Spinal Cord Injury Participants with SCI | 248 |
| Total | 248 |
Baseline characteristics
| Characteristic | Spinal Cord Injury |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 63 Participants |
| Age, Categorical Between 18 and 65 years | 185 Participants |
| Age, Continuous | 56.98 years STANDARD_DEVIATION 12.56 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 218 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 50 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 23 Participants |
| Race (NIH/OMB) White | 168 Participants |
| Region of Enrollment United States | 248 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 236 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 248 |
| serious Total, serious adverse events | 0 / 248 |
Outcome results
Primary
SCI-QoL Independence
Average score on a questionnaire about level of independence. The minimum score on the scale is 24.6 and the maximum is 68.9. Fifty is the average score. Values below 50 indicate a worse outcome. Values above 50 represent a better outcome.
Time frame: Baseline
Population: One participant did not completed item bank or outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Cord Injury | SCI-QoL Independence | 49.9 units on a scale | Standard Deviation 10.2 |
Secondary
SCI-QoL Ability to Participate in Social Roles and Activities
Average score on a SCI-QoL Ability to Participate in Social Roles and Activities scale. The minimum score on the scale is 25.1 and the maximum is 61.1. A higher score represents better functioning (more ability to participate in social roles and activities).
Time frame: Baseline
Population: One participant did not completed item bank or outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Cord Injury | SCI-QoL Ability to Participate in Social Roles and Activities | 45.5 units on a scale | Standard Deviation 8 |
Secondary
SCI-QoL Anxiety
Average score on SCI-QoL Anxiety. The minimum score on the scale is 36.3 and the maximum is 84.2. A higher score represents more anxiety (worse functioning). A lower score represents less anxiety (better functioning).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Cord Injury | SCI-QoL Anxiety | 48.3 units on a scale | Standard Deviation 10.2 |
Secondary
SCI-QoL Bladder Management Difficulties
Average score on SCI-QoL Bladder Management Difficulties. The minimum score on the scale is 39.7 and the maximum is 76.8. A higher score represents more bladder management difficulties (worse functioning). A lower score represents fewer bladder management difficulties (better functioning).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Cord Injury | SCI-QoL Bladder Management Difficulties | 50.5 units on a scale | Standard Deviation 9.6 |
Secondary
SCI-QoL Bowel Management Difficulties
Average score on SCI-QoL Bowel Management Difficulties. The minimum score on the scale is 39.2 and the maximum is 76.3. A higher score represents more bowel management difficulties (worse functioning). A lower score represents fewer bowel management difficulties (better functioning).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Cord Injury | SCI-QoL Bowel Management Difficulties | 47.5 units on a scale | Standard Deviation 9.8 |
Secondary
SCI-QoL Depression
Average score on SCI-QoL Depression. The minimum score on the scale is 38.3 and the maximum is 81.9. A higher score represents more depression (worse functioning). A lower score represents less depression (better functioning).
Time frame: Baseline
Population: One participant did not completed item bank or outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Cord Injury | SCI-QoL Depression | 47.7 units on a scale | Standard Deviation 9.9 |
Secondary
SCI-QoL Pain Behavior
Average score on SCI-QoL Pain Behavior. The minimum score on the scale is 38.2 and the maximum is 76.1. A higher score represents more pain behavior (worse functioning). A lower score represents less pain behavior (better functioning).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Cord Injury | SCI-QoL Pain Behavior | 53.7 units on a scale | Standard Deviation 9.5 |
Secondary
SCI-QoL Pain Interference
Average score on SCI-QoL Pain Interference. The minimum score on the scale is 40.2 and the maximum is 79.7. A higher score represents more pain interference (worse functioning). A lower score represents less anxiety (better functioning).
Time frame: Baseline
Population: One participant did not completed item bank or outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Cord Injury | SCI-QoL Pain Interference | 54.8 units on a scale | Standard Deviation 10.2 |
Secondary
SCI-QoL Positive Affect and Well-being
Average score on SCI-QoL Positive Affect and Well-being. The minimum score on the scale is 26.7 and the maximum is 68.6. A higher score represents more positive affect and well-being (better functioning).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Cord Injury | SCI-QoL Positive Affect and Well-being | 55.7 units on a scale | Standard Deviation 9 |
Secondary
SCI-QoL Resilience
Average score on SCI-QoL Resilience. The minimum score on the scale is 16.4 and the maximum is 66.4. A higher score represents more resilience (better functioning).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Cord Injury | SCI-QoL Resilience | 53.9 units on a scale | Standard Deviation 11.6 |
Secondary
SCI-QoL Satisfaction With Social Roles and Activities
Average score on SCI-QoL Satisfaction with Social Roles and Activities. The minimum score on the scale is 28.3 and the maximum is 60.5. A higher score represents more satisfaction with social roles and activities (better functioning).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Cord Injury | SCI-QoL Satisfaction With Social Roles and Activities | 47.5 units on a scale | Standard Deviation 6.9 |
Secondary
SCI-QoL Stigma
Average score on SCI-QoL Stigma. The minimum score on the scale is 37.8 and the maximum is 77.3. A higher score represents more stigma (worse functioning). A lower score represents less stigma (better functioning).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Cord Injury | SCI-QoL Stigma | 50.9 units on a scale | Standard Deviation 7.9 |
Secondary
SCI-QoL Trauma
Average score on SCI-QoL Trauma. The minimum score on the scale is 38.4 and the maximum is 85.2. A higher score represents more trauma (worse functioning). A lower score represents less trauma (better functioning).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Cord Injury | SCI-QoL Trauma | 46.8 units on a scale | Standard Deviation 10.3 |
Other Pre-specified
SCI-QoL Grief Loss
Average score on SCI-QoL Grief Loss. The minimum score on the scale is 30.9 and the maximum is 76.1. A higher score represents more grief/loss (worse functioning). A lower score represents less grief/loss (better functioning).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Cord Injury | SCI-QoL Grief Loss | 46.5 units on a scale | Standard Deviation 11 |