Nursing Management of Irritable Bowel Syndrome:Improving Outcomes

This study has been completed.

Sponsor:

Collaborator:

National Institute of Nursing Research (NINR)

Information provided by:

University of Washington

ClinicalTrials.gov Identifier:

NCT00167635

First received: September 9, 2005

Last updated: May 21, 2009

Last verified: May 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

May 21, 2009

Start Date ^ICMJE

January 2003

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Gastrointestinal symptoms [ Time Frame: baseline, and 3 months, 6 months, 12 months post randomization ] [ Designated as safety issue: No ]
Psychological distress [ Time Frame: baseline, and 3 months, 6 months, 12 months post randomization ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00167635 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Sleep disturbance [ Time Frame: baseline, and 3 months, 6 months, 12 months post randomization ] [ Designated as safety issue: No ]
Sexual dysfunction [ Time Frame: baseline, and 3 months, 6 months, 12 months post randomization ] [ Designated as safety issue: No ]
Catecholamine and cortisol levels (urine) [ Time Frame: baseline, and 3 months, 6 months, 12 months post randomization ] [ Designated as safety issue: No ]
Stool frequency/consistency [ Time Frame: baseline, and 3 months, 6 months, 12 months post randomization ] [ Designated as safety issue: No ]
Health care utilization [ Time Frame: baseline, and 3 months, 6 months, 12 months post randomization ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Sleep disturbance
Sexual dysfunction
Catecholamine and cortisol levels (urine)

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Nursing Management of Irritable Bowel Syndrome:Improving Outcomes

Official Title ^ICMJE

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 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Irritable Bowel Syndrome

Intervention ^ICMJE

Behavioral: cognitive-behavioral

Cognitive-behavioral over 9 weeks

Other Names:

Cognitive-behavioral
Usual care

Study Arm (s)

Experimental: 1
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.

Intervention: Behavioral: cognitive-behavioral
Experimental: 2
Telephone Individualized Comprehensive Self-Management (CSM-TEL) Group. Participants in the individualized CSM-FTF 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.

Intervention: Behavioral: cognitive-behavioral
No Intervention: 3
Usual Care Control Group (UC). Following randomization the participants in the control group will receive two short phone calls to maintain contact during the comparable 9-week intervention in the treatment groups.

Intervention: Behavioral: cognitive-behavioral

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

188

Completion Date

February 2008

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Irritable Bowel Syndrome

Exclusion Criteria:

GI pathology (organic disease)
Co-morbid pain disorders

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00167635

Other Study ID Numbers ^ICMJE

12707-C, 2R01NR04142-5, 97-3895-C 11

Has Data Monitoring Committee

Yes

Responsible Party

Margaret Heitkember, University of Washington

Study Sponsor ^ICMJE

University of Washington

Collaborators ^ICMJE

National Institute of Nursing Research (NINR)

Investigators ^ICMJE

Principal Investigator:

Margaret M Heitkemper

University of Washington

Information Provided By

University of Washington

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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