Nursing Management of Irritable Bowel Syndrome:Improving Outcomes
4 other identifiers
interventional
188
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2003
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedMay 25, 2009
May 1, 2009
5.1 years
September 9, 2005
May 21, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Gastrointestinal symptoms
baseline, and 3 months, 6 months, 12 months post randomization
Psychological distress
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.
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.
baseline, and 3 months, 6 months, 12 months post randomization
Secondary Outcomes (5)
Sleep disturbance
baseline, and 3 months, 6 months, 12 months post randomization
Sexual dysfunction
baseline, and 3 months, 6 months, 12 months post randomization
Catecholamine and cortisol levels (urine)
baseline, and 3 months, 6 months, 12 months post randomization
Stool frequency/consistency
baseline, and 3 months, 6 months, 12 months post randomization
Health care utilization
baseline, and 3 months, 6 months, 12 months post randomization
Study Arms (3)
1
EXPERIMENTALFace-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.
2
EXPERIMENTALTelephone 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.
3
NO INTERVENTIONUsual 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.
Interventions
Eligibility Criteria
You may qualify if:
- Irritable Bowel Syndrome
You may not qualify if:
- GI pathology (organic disease)
- Co-morbid pain disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Northgate Executive 1
Seattle, Washington, 98125, United States
University of Washington
Seattle, Washington, 98195, United States
Related Publications (4)
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. doi: 10.1016/s1542-3565(04)00242-3.
PMID: 15224283BACKGROUNDYang PL, Burr RL, Buchanan DT, Pike KC, Kamp KJ, Heitkemper MM. Indirect effect of sleep on abdominal pain through daytime dysfunction in adults with irritable bowel syndrome. J Clin Sleep Med. 2020 Oct 15;16(10):1701-1710. doi: 10.5664/jcsm.8658.
PMID: 32620184DERIVEDKamp KJ, Weaver KR, Sherwin LB, Barney P, Hwang SK, Yang PL, Burr RL, Cain KC, Heitkemper MM. Effects of a comprehensive self-management intervention on extraintestinal symptoms among patients with IBS. J Psychosom Res. 2019 Nov;126:109821. doi: 10.1016/j.jpsychores.2019.109821. Epub 2019 Aug 29.
PMID: 31499231DERIVEDHan CJ, Kohen R, Jun S, Jarrett ME, Cain KC, Burr R, Heitkemper MM. COMT Val158Met Polymorphism and Symptom Improvement Following a Cognitively Focused Intervention for Irritable Bowel Syndrome. Nurs Res. 2017 Mar/Apr;66(2):75-84. doi: 10.1097/NNR.0000000000000199.
PMID: 28252569DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Margaret M Heitkemper
University of Washington
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 14, 2005
Study Start
January 1, 2003
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
May 25, 2009
Record last verified: 2009-05