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Nursing Management of Irritable Bowel Syndrome (IBS) 2008

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ClinicalTrials.gov Identifier: NCT00907790
Recruitment Status : Completed
First Posted : May 25, 2009
Last Update Posted : May 4, 2017
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Monica Jarrett, University of Washington

Tracking Information
First Submitted Date  ICMJE May 21, 2009
First Posted Date  ICMJE May 25, 2009
Last Update Posted Date May 4, 2017
Study Start Date  ICMJE March 2009
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2009)
  • Daily abdominal pain [ Time Frame: Baseline, three and six months post randomization ]
  • IBS Quality of Life Questionnaire [ Time Frame: Baseline, three and six months post randomization ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00907790 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2013)
  • Salivary cortisol [ Time Frame: Baseline, three and six months post randomization ]
  • Interleukin-10(IL-10) and Interleukin-12(IL-12) [ Time Frame: Baseline, three and six months post randomization ]
  • Fecal calprotectin [ Time Frame: Baseline, three and six months post randomization ]
  • Intestinal permeability (urine) [ Time Frame: Baseline, three and six months post randomization ]
  • Brief Symptom Inventory [ Time Frame: Baseline, three and six months post randomization ]
  • Cognitive Scale for Functional Bowel Disorders [ Time Frame: Baseline three and six months post randomization ]
  • Work Productivity & Activity Impairment [ Time Frame: Baseline, three and six months post rand ]
  • Daily symptoms(other GI and psychological) [ Time Frame: Baseline, three and six months post randomization ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2009)
  • Salivary cortisol [ Time Frame: Baseline, three and six months post randomization ]
  • IL-10 and IL-12 [ Time Frame: Baseline, three and six months post randomization ]
  • Fecal calprotectin [ Time Frame: Baseline, three and six months post randomization ]
  • Intestinal permeability (urine) [ Time Frame: Baseline, three and six months post randomization ]
  • Brief Symptom Inventory [ Time Frame: Baseline, three and six months post randomization ]
  • Cognitive Scale for Functional Bowel Disorders [ Time Frame: Baseline three and six months post randomization ]
  • Work Productivity & Activity Impairment [ Time Frame: Baseline, three and six months post rand ]
  • Daily symptoms(other GI and psychological) [ Time Frame: Baseline, three and six months post randomization ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nursing Management of Irritable Bowel Syndrome (IBS) 2008
Official Title  ICMJE Nursing Management of IBS:Improving Outcomes
Brief Summary The aim of this study is test the efficacy of a comprehensive self-management therapy to decrease abdominal pain/discomfort and improve quality of life in patients with irritable bowel syndrome (IBS) compared to IBS patients receiving their usual care.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE
  • Behavioral: Usual Care (Control Group)
  • Behavioral: Comprehensive Self-Management (CSM)
    Comprehensive Self-Management includes 8 sessions that cover education, diet, relaxation training, and cognitive behavioral strategies as they related to symptoms of IBS
Study Arms  ICMJE
  • Experimental: Comprehensive Self-Management (CSM)

    Comprehensive Self-Management includes 8 sessions that cover education, diet, relaxation training, and cognitive behavioral strategies as they related to symptoms of IBS

    --------------------------------------------------------------------------------

    Intervention: Behavioral: Comprehensive Self-Management (CSM)
  • Usual Care (Control Group)
    Includes the usual care provided by the person and their health care provider.
    Intervention: Behavioral: Usual Care (Control Group)
Publications *

*   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
Actual Enrollment  ICMJE
 (submitted: January 14, 2013)
92
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2009)
120
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women must be: 18-70 years old, have had symptoms of Irritable Bowel Syndrome (IBS) at least 6 mo prior to their diagnosis, and have had their diagnosis for at least 6 months, and the diagnosis had to be made by a health care provider (e.g., internist, gastroenterologist, family, nurse practitioner, physician assistant).
  • In addition, the subjects must be experiencing IBS symptoms as described in the Rome-III criteria.161 That is recurrent abdominal pain or discomfort at least 3 days a mo in the last 3 mo associated with 2 or more of the following: improvement with defecation, onset associated with a change in frequency or form (appearance) of their stool.
  • Adults 50 or older must have a negative colonoscopy, sigmoidoscopy, abdominal ultrasonography, or barium enema.
  • Anyone with a "red flag" symptom (e.g., lost 10 lbs without trying, blood in stool, anemia) will be contacted for additional clarification.

Exclusion Criteria:

  • Participants will be excluded if they are taking the following medications: antibiotics, daily use of anticholinergics, tricyclic antidepressants, calcium-channel blockers
  • Have a medical history of abdominal surgery (except appendectomy, Caesarian section, tubal ligation, laparoscopic cholecystectomy, hysterectomy, or abdominal wall hernia repair)
  • Active organic GI disease, gluten intolerance (celiac disease), or chronic moderate to severe pain condition (e.g., low back pain, fibromyalgia)
  • Recent travel to regions with endemic parasitic diseases
  • Current mental health disorders (psychosis, bipolar disorder, current moderate to severe depressive episode, suicide attempt, drug or alcohol abuse or dependence within 2yrs)
  • Cardiac valvular disease, immune compromised immunologic disorders (e.g., autoimmune conditions)
  • Women who are pregnant, breast feeding, or planning to get pregnant in the next year
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00907790
Other Study ID Numbers  ICMJE 32722
2R01NR004142 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Monica Jarrett, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE National Institute of Nursing Research (NINR)
Investigators  ICMJE
Principal Investigator: Maargaret M Heitkemper, PhD University of Washington
PRS Account University of Washington
Verification Date May 2017

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