Nursing Management of Irritable Bowel Syndrome (IBS) 2008

May 1, 2017 updated by: Monica Jarrett, University of Washington

Nursing Management of IBS:Improving Outcomes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

--------------------------------------------------------------------------------
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
Other: Usual Care (Control Group)
Includes the usual care provided by the person and their health care provider.
Behavioral: Usual Care (Control Group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Daily abdominal pain
Time Frame: Baseline, three and six months post randomization
Baseline, three and six months post randomization
IBS Quality of Life Questionnaire
Time Frame: Baseline, three and six months post randomization
Baseline, three and six months post randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Salivary cortisol
Time Frame: Baseline, three and six months post randomization
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
Baseline, three and six months post randomization
Fecal calprotectin
Time Frame: Baseline, three and six months post randomization
Baseline, three and six months post randomization
Intestinal permeability (urine)
Time Frame: Baseline, three and six months post randomization
Baseline, three and six months post randomization
Brief Symptom Inventory
Time Frame: Baseline, three and six months post randomization
Baseline, three and six months post randomization
Cognitive Scale for Functional Bowel Disorders
Time Frame: Baseline three and six months post randomization
Baseline three and six months post randomization
Work Productivity & Activity Impairment
Time Frame: Baseline, three and six months post rand
Baseline, three and six months post rand
Daily symptoms(other GI and psychological)
Time Frame: Baseline, three and six months post randomization
Baseline, three and six months post randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Maargaret M Heitkemper, PhD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

May 21, 2009

First Submitted That Met QC Criteria

May 22, 2009

First Posted (Estimate)

May 25, 2009

Study Record Updates

Last Update Posted (Actual)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 32722
  • 2R01NR004142 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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