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Nursing Management of Irritable Bowel Syndrome:Improving Outcomes

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00167635
First received: September 9, 2005
Last updated: May 21, 2009
Last verified: May 2009

September 9, 2005
May 21, 2009
January 2003
February 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • Gastrointestinal symptoms
  • Psychological distress
  • Health care utilization
  • Stool frequency/consistency
  • Quality of life
Complete list of historical versions of study NCT00167635 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Sleep disturbance
  • Sexual dysfunction
  • Catecholamine and cortisol levels (urine)
Not Provided
Not Provided
 
Nursing Management of Irritable Bowel Syndrome:Improving Outcomes
Nursing Management of Irritable Bowel Syndrome: Improving Outcomes

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Irritable Bowel Syndrome
Behavioral: cognitive-behavioral
Cognitive-behavioral over 9 weeks
Other Names:
  • Cognitive-behavioral
  • Usual care
  • 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
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.
 
Completed
188
February 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Irritable Bowel Syndrome

Exclusion Criteria:

  • GI pathology (organic disease)
  • Co-morbid pain disorders
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00167635
12707-C, 2R01NR04142-5, 97-3895-C 11
Yes
Margaret Heitkember, University of Washington
University of Washington
National Institute of Nursing Research (NINR)
Principal Investigator: Margaret M Heitkemper University of Washington
University of Washington
May 2009

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