VA Gastrointestinal (GI) Quality of Life Survey (VA GI QOL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00860990
Recruitment Status : Terminated (Outcome measures are included in another, similar study.)
First Posted : March 13, 2009
Last Update Posted : June 26, 2015
Information provided by:
VA Office of Research and Development

Brief 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 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.

Condition or disease Intervention/treatment
SCI Other: Completion of GI quality of life survey

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 Type : Observational
Estimated Enrollment : 100 participants
Time Perspective: Prospective
Official Title: VA GI Quality of Life Survey
Study Start Date : April 2007
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Group/Cohort Intervention/treatment
SCI or disabled
Other: Completion of GI quality of life survey
Subjects are asked to complete a survey related to bowel care and its effects on various variables related to quality of life.
Other: Completion of GI quality of life survey
Subjects are asked to complete a survey related to bowel care and its effects on various variables related to quality of life.

Primary Outcome Measures :
  1. Quality of life relative to bowel function and care [ Time Frame: 3-6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Inclusion Criteria:

  • 18+ years of age
  • Able to understand English

Exclusion Criteria:

  • Diagnosed dementia, severe TBI or other conditions which limit the ability to provide acute information in the judgment of the investigators.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00860990

United States, New York
VA Medical Center, Bronx
Bronx, New York, United States, 10468
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Mark A. Korsten, MD VA Medical Center, Bronx

Responsible Party: Korsten, Mark - Principal Investigator, Department of Veterans Affairs Identifier: NCT00860990     History of Changes
Other Study ID Numbers: B4162C-4
First Posted: March 13, 2009    Key Record Dates
Last Update Posted: June 26, 2015
Last Verified: June 2015