Spinal Cord InjuriesNCT01238549
Extending Veteran Participation in the Validation of the SCI-QOL/CAT
An observational study of Spinal Cord Injuries, run by VA Office of Research and Development at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Spinal Cord Injuries
- How many people
- 284 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2012to 31 Dec 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Veterans at the James J. Peters Veterans Affairs Medical Center or the James A. Haley Veterans Affairs Hospital with spinal cord injury
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
James A. Haley Veterans' Hospital
Tampa, Florida, 33612
James J. Peters VA Medical Center
The Bronx, New York, 10468
About this study
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.
Read more
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.
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injuries, Quality of Life
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Cord Injury | Participants with SCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (12)
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).
Measured: Baseline
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).
Measured: Baseline
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).
Measured: Baseline
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).
Measured: Baseline
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).
Measured: Baseline
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).
Measured: Baseline
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).
Measured: Baseline
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).
Measured: Baseline
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).
Measured: Baseline
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).
Measured: Baseline
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).
Measured: Baseline
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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study start1 May 2012
- Primary completion31 Dec 2015
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Ann M Spungen, EdD, Principal investigator, James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238549
- Sponsor's protocol ID
- B7566-R
- Status last verified
- Nov 2018
- First submitted
- 8 Nov 2010
- Last updated
- 29 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extending Veteran Participation in the Validation of the SCI-QOL/CAT
- ClinicalTrials.gov ID
- NCT01238549
- Acronym / sponsor ID
- B7566-R
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injuries, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 May 2012 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 10 Nov 2010 (estimated)
- Results
- Posted 2 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Injury | – | –Participants with SCI |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans at the James J. Peters Veterans Affairs Medical Center or the James A. Haley Veterans Affairs Hospital with spinal cord injury
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SCI-QoL Independence
Time frame: 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.
12 secondary outcomes
SCI-QoL Ability to Participate in Social Roles and Activities
Time frame: Baseline
SCI-QoL Anxiety
Time frame: Baseline
SCI-QoL Bowel Management Difficulties
Time frame: Baseline
SCI-QoL Bladder Management Difficulties
Time frame: Baseline
SCI-QoL Depression
Time frame: Baseline
SCI-QoL Pain Behavior
Time frame: Baseline
SCI-QoL Pain Interference
Time frame: Baseline
SCI-QoL Positive Affect and Well-being
Time frame: Baseline
SCI-QoL Resilience
Time frame: Baseline
SCI-QoL Satisfaction With Social Roles and Activities
Time frame: Baseline
SCI-QoL Stigma
Time frame: Baseline
SCI-QoL Trauma
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Ann M Spungen, EdD principal investigator
James J. Peters Veterans Affairs Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by VA Office of Research and Development at 2 sites 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 3 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 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 2 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
SCI-QoL Independence (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2018.