SCIVA GI QOLNCT00860990
VA Gastrointestinal (GI) Quality of Life Survey
An observational study of SCI, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Spinal cord injury (SCI) often results in reduced bowel function and regularity, leading to a decrease in quality of life for those who are affected. Evidence-based research has indicated that, when surveyed, individuals with SCI express a greater reduction in quality of life derived from their bowel routine than… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SCI
- What is being tested?
- Completion of GI quality of life survey
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Apr 2010
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers will be recruited from the spinal cord injury service/clinic, the primary care service/clinic, the geriatric service/clinic, the chronic kidney service/clinic, and the rehabilitation service/clinic at the James J. Peters VA Medical Center.
Who may be able to join
- 18+ years of age
- Able to understand English
Who cannot join
- Diagnosed dementia, severe TBI or other conditions which limit the ability to provide acute information in the judgment of the investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VA GI Quality of Life Survey
Spinal cord injury (SCI) often results in reduced bowel function and regularity, leading to a decrease in quality of life for those who are affected. Evidence-based research has indicated that, when surveyed, individuals with SCI express a greater reduction in quality of life derived from their bowel routine than able-bodied subjects. In addition, the extent of reduction in quality of life has a direct relationship with the level of Injury. Those with tetraplegia score worse than those with paraplegia and paraplegics score worse than controls. The development of an adequate quality of life questionnaire is needed to effectively identify the impact of bowel care on quality of life in patients with SCI compared to able-bodied controls. The purpose of this study is to determine the discriminatory ability of the survey for various diagnoses such as SCI, CVA, TBI, chronic back pain, radiculopathy from the Rehabilitation Service and able bodied persons.
Read the detailed description
In an abstract " A Bowel Care Survey to Assess Quality of Life in Persons With Spinal Cord Injury" in Journal of Spinal Cord Medicine in 2006, JP Lirio, et al surveyed 20 subjects (10 controls, 5 para, 5 tetra). The survey consisted of 42 items relating to GI function, bowel program/routine and quality of life. Survey items were weighted across a range of outcomes (e.g., complete continence=0 to frequent incontinence of solid evacuate=5). Total survey scores were compared among the groups by ANOVA with a Scheffe post hoc test. In those with SCI, level of injury (LOI) was converted to a numeric value and the relationship between LOI and total score was determined by simple regression.
The range of scores across the groups was 2 to 111 points. The controls scored significantly lower than those in the Para group who were significantly lower than those in the Tetra group (6 5 vs. 46 38 vs. 92 24, P<0.01, respectively). Within SCI, 43% of the variance of the total score was explained by level of injury. (r2=42.5, P<0.05), which is suggestive for the potential of good content validity of this tool. The authors concluded that the preliminary results of this survey show that persons with greater degrees of neurological impairment also manifest a greater negative impact from bowel care on their QoL. These results are encouraging for being able to develop a sensitive tool that will capture changes in bowel care status after therapeutic intervention that would be expected to influence QoL.
Innovative and potentially efficacious treatments for bowel care are being developed. There is a clinical/investigative need for a valid survey that is sensitive to quality of life (QoL) changes relating to interventions for bowel care in those with spinal cord injury (SCI). This is an ongoing project to develop a self-reported gastrointestinal (GI) survey that measures the impact of bowel function on QoL in individuals with SCI. This research seeks to develop a quality of life questionnaire that can be used to assess bowel function in able bodied individuals as well as spinal cord patients. This tool is essential for measuring change in bowel function due to an intervention or aging, rehabilitation, medications, etc.
- Conditions
- SCI
- Being tested
- Completion of GI quality of life survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Completion of GI quality of life surveyOther
Subjects are asked to complete a survey related to bowel care and its effects on various variables related to quality of life.
| Study group | Role | What they receive |
|---|---|---|
| 1 | SCI or disabled Receives: Other: Completion of GI quality of life survey | |
| 2 | Able-bodied Receives: Other: Completion of GI quality of life survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life relative to bowel function and care
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startApr 2007
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: Outcome measures are included in another, similar study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCIStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Mark A. Korsten, MD, Principal investigator, VA Medical Center, Bronx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860990
- Sponsor's protocol ID
- B4162C-4
- Other IDs
- 2380-07-042
- Acronym
- VA GI QOL
- Status last verified
- Jun 2015
- First submitted
- 6 Mar 2009
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VA GI Quality of Life Survey
- ClinicalTrials.gov ID
- NCT00860990
- Acronym / sponsor ID
- VA GI QOL / B4162C-4
- Conditions
- SCI
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Outcome measures are included in another, similar study.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Apr 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 13 Mar 2009 (estimated)
- 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.
Spinal cord injury (SCI) often results in reduced bowel function and regularity, leading to a decrease in quality of life for those who are affected. Evidence-based research has indicated that, when surveyed, individuals with SCI express a greater reduction in quality of life derived from their bowel routine than able-bodied subjects. In addition, the extent of reduction in quality of life has a direct relationship with the level of Injury. Those with tetraplegia score worse than those with paraplegia and paraplegics score worse than controls. The development of an adequate quality of life questionnaire is needed to effectively identify the impact of bowel care on quality of life in patients with SCI compared to able-bodied controls. The purpose of this study is to determine the discriminatory ability of the survey for various diagnoses such as SCI, CVA, TBI, chronic back pain, radiculopathy from the Rehabilitation Service and able bodied persons.
Detailed description
In an abstract " A Bowel Care Survey to Assess Quality of Life in Persons With Spinal Cord Injury" in Journal of Spinal Cord Medicine in 2006, JP Lirio, et al surveyed 20 subjects (10 controls, 5 para, 5 tetra). The survey consisted of 42 items relating to GI function, bowel program/routine and quality of life. Survey items were weighted across a range of outcomes (e.g., complete continence=0 to frequent incontinence of solid evacuate=5). Total survey scores were compared among the groups by ANOVA with a Scheffe post hoc test. In those with SCI, level of injury (LOI) was converted to a numeric value and the relationship between LOI and total score was determined by simple regression.
The range of scores across the groups was 2 to 111 points. The controls scored significantly lower than those in the Para group who were significantly lower than those in the Tetra group (6 5 vs. 46 38 vs. 92 24, P<0.01, respectively). Within SCI, 43% of the variance of the total score was explained by level of injury. (r2=42.5, P<0.05), which is suggestive for the potential of good content validity of this tool. The authors concluded that the preliminary results of this survey show that persons with greater degrees of neurological impairment also manifest a greater negative impact from bowel care on their QoL. These results are encouraging for being able to develop a sensitive tool that will capture changes in bowel care status after therapeutic intervention that would be expected to influence QoL.
Innovative and potentially efficacious treatments for bowel care are being developed. There is a clinical/investigative need for a valid survey that is sensitive to quality of life (QoL) changes relating to interventions for bowel care in those with spinal cord injury (SCI). This is an ongoing project to develop a self-reported gastrointestinal (GI) survey that measures the impact of bowel function on QoL in individuals with SCI. This research seeks to develop a quality of life questionnaire that can be used to assess bowel function in able bodied individuals as well as spinal cord patients. This tool is essential for measuring change in bowel function due to an intervention or aging, rehabilitation, medications, etc.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Completion of GI quality of life surveySCI or disabled |
| 2 | – | Other: Completion of GI quality of life surveyAble-bodied |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers will be recruited from the spinal cord injury service/clinic, the primary care service/clinic, the geriatric service/clinic, the chronic kidney service/clinic, and the rehabilitation service/clinic at the James J. Peters VA Medical Center.
Key inclusion criteria (2 listed)
- 18+ years of age
- Able to understand English
Key exclusion criteria (1 listed)
- Diagnosed dementia, severe TBI or other conditions which limit the ability to provide acute information in the judgment of the investigators.
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 |
|---|---|---|
| Completion of GI quality of life surveySubjects are asked to complete a survey related to bowel care and its effects on various variables related to quality of life. | Other | 1, 2 |
Primary outcome
Quality of life relative to bowel function and care
Time frame: 3-6 months
Results and safety
The study was stopped early (reason given: Outcome measures are included in another, similar study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2015.
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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.
Mark A. Korsten, MD principal investigator
VA Medical Center, Bronx
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SCI, run by US Department of Veterans Affairs 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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 26 Jun 2015. 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 was stopped early (reason given: Outcome measures are included in another, similar study.). Results are not available in the source record.
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?
Quality of life relative to bowel function and care (time frame: 3-6 months). 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 26 Jun 2015.