Clinical Trial: Nursing Management of Irritable Bowel Syndrome:Improving Outcomes

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Nursing Management of Irritable Bowel Syndrome: Improving Outcomes

Brief Summary: The purpose of this study is 1) to determine whether a comprehensive self-management intervention is effective in a sample that includes men and women with irritable bowel syndrome, and 2) to determine whether the comprehensive self-management intervention is as effective when delivered over the telephone as compared to a face-to-face approach.

Detailed Summary:

Randomization and Intervention Phase. Upon completing the baseline assessment phase, participants will be randomized to one of 3 treatment groups. A customized computer program will be used to do the randomization in an adaptive manner that ensures the 3 groups remain fairly balanced with respect to possible important predictors of outcomes: age, sex, predominant stool pattern (alternating, constipation-predominant or diarrhea-predominant), and severity of IBS symptoms and psychological symptoms at baseline. When each new participant is randomized, the program will adjust the probabilities of assignment to the three groups so that there is a higher probability of assignment to the group that results in the best balance.

Intervention Groups. Face-to-Face Individualized Comprehensive Self-Management (CSM-FF) Group. Participants in the individualized CSM-FF group will be scheduled for 9 weekly sessions with the nurse therapist followed by post-intervention follow-up assessment.

Telephone Individualized Comprehensive Self-Management (CSM-TEL) Group. Participants in the individualized CSM-TEL group will initially have 2 face-to-face meetings with the nurse therapist, 6 sessions over the phone and the final session face-to-face at 9 weeks.

Usual Care Control Group (UC). Following randomization the participants in the control group will no receive any contacts during the comparable 9-week intervention in the treatment groups.

Follow-up Phase. Participants in all 3 groups will be reassessed at 3-mo, 6-mo, and 12-mo post randomization. At this time the participants will complete questionnaires, a 4 week diary and collect 4 urines.


Sponsor: University of Washington

Current Primary Outcome:

  • Gastrointestinal symptoms [ Time Frame: baseline, and 3 months, 6 months, 12 months post randomization ]
  • Psychological distress [ Time Frame: baseline, and 3 months, 6 months, 12 months post randomization ]
  • Cognitive Scale for Functional Bowel Disorders (CFBD) describes 25 cognitive beliefs related to functional bowel disorders. [ Time Frame: baseline, and 3 months, 6 months, 12 months post randomization ]
  • Health Related Quality Of Life (HRQOL) will be measures with the Disease Specific Questionnaire-IBS (IBS-DSQ), a 42-item questionnaire. [ Time Frame: baseline, and 3 months, 6 months, 12 months post randomization ]


Original Primary Outcome:

  • Gastrointestinal symptoms
  • Stool frequency/consistency
  • Psychological distress
  • Quality of life
  • Health care utilization


Current Secondary Outcome:

  • Sleep disturbance [ Time Frame: baseline, and 3 months, 6 months, 12 months post randomization ]
  • Sexual dysfunction [ Time Frame: baseline, and 3 months, 6 months, 12 months post randomization ]
  • Catecholamine and cortisol levels (urine) [ Time Frame: baseline, and 3 months, 6 months, 12 months post randomization ]
  • Stool frequency/consistency [ Time Frame: baseline, and 3 months, 6 months, 12 months post randomization ]
  • Health care utilization [ Time Frame: baseline, and 3 months, 6 months, 12 months post randomization ]


Original Secondary Outcome:

  • Sleep disturbance
  • Sexual dysfunction
  • Catecholamine and cortisol levels (urine)


Information By: University of Washington

Dates:
Date Received: September 9, 2005
Date Started: January 2003
Date Completion:
Last Updated: May 21, 2009
Last Verified: May 2009