Nursing Management of Irritable Bowel Syndrome:Improving Outcomes

Irritable Bowel Syndrome Clinical Trial

Official title:

Nursing Management of Irritable Bowel Syndrome: Improving Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00167635
• Other study ID #: 12707-C
• Secondary ID: 2R01NR04142-597-
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 9, 2005
• Last updated: May 21, 2009
• Start date: January 2003
• Est. completion date: February 2008

Study information

• Verified date: May 2009
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Irritable Bowel Syndrome

Exclusion Criteria:

• GI pathology (organic disease)

• Co-morbid pain disorders

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Behavioral:
• cognitive-behavioral
Cognitive-behavioral over 9 weeks

Locations

Country	Name	City	State
United States	Northgate Executive 1	Seattle	Washington
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Heitkemper MM, Jarrett ME, Levy RL, Cain KC, Burr RL, Feld A, Barney P, Weisman P. Self-management for women with irritable bowel syndrome. Clin Gastroenterol Hepatol. 2004 Jul;2(7):585-96. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal symptoms		baseline, and 3 months, 6 months, 12 months post randomization
Primary	Psychological distress		baseline, and 3 months, 6 months, 12 months post randomization
Primary	Cognitive Scale for Functional Bowel Disorders (CFBD) describes 25 cognitive beliefs related to functional bowel disorders.		baseline, and 3 months, 6 months, 12 months post randomization
Primary	Health Related Quality Of Life (HRQOL) will be measures with the Disease Specific Questionnaire-IBS (IBS-DSQ), a 42-item questionnaire.		baseline, and 3 months, 6 months, 12 months post randomization
Secondary	Sleep disturbance		baseline, and 3 months, 6 months, 12 months post randomization
Secondary	Sexual dysfunction		baseline, and 3 months, 6 months, 12 months post randomization
Secondary	Catecholamine and cortisol levels (urine)		baseline, and 3 months, 6 months, 12 months post randomization
Secondary	Stool frequency/consistency		baseline, and 3 months, 6 months, 12 months post randomization
Secondary	Health care utilization		baseline, and 3 months, 6 months, 12 months post randomization