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

This study has been terminated.
(Outcome measures are included in another, similar study.)
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00860990
First received: March 6, 2009
Last updated: July 15, 2010
Last verified: July 2010
  Purpose

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 Intervention
SCI
Other: Completion of GI quality of life survey

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: VA GI Quality of Life Survey

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Quality of life relative to bowel function and care [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2007
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
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.
2
Able-bodied
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860990

Locations
United States, New York
VA Medical Center, Bronx
Bronx, New York, United States, 10468
Sponsors and Collaborators
Investigators
Principal Investigator: Mark A. Korsten, MD VA Medical Center, Bronx
  More Information

No publications provided

Responsible Party: Korsten, Mark - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00860990     History of Changes
Other Study ID Numbers: B4162C-4, 2380-07-042
Study First Received: March 6, 2009
Last Updated: July 15, 2010
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on November 24, 2014