VA Gastrointestinal (GI) Quality of Life Survey

NCT00860990 | Terminated

• 2 other identifiers: B4162C-42380-07-042
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

SCI

Outcome Measures

Primary Outcomes (1)

• Quality of life relative to bowel function and care

  3-6 months

Study Arms (2)

1

SCI or disabled

Other: Completion of GI quality of life survey

2

Able-bodied

Other: Completion of GI quality of life survey

Interventions

Completion of GI quality of life survey OTHER

Subjects are asked to complete a survey related to bowel care and its effects on various variables related to quality of life.

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• + years of age
• Able to understand English

You may not qualify if:

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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Medical Center, Bronx

The Bronx, New York, 10468, United States

Location

Study Officials

• Mark A. Korsten, MD

  VA Medical Center, Bronx

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED

Study Record Dates

• First Submitted: March 6, 2009
• First Posted: March 13, 2009
• Study Start: April 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: June 26, 2015

Record last verified: 2015-06

Locations

US (1)