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Self-Management Program for Inflammatory Bowel Disease

N/A
Recruiting
Led By Kendra Kamp, PHD, RN
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new self-management program for people with IBD to help them manage symptoms. It includes 8 sessions on topics like symptom tracking, behavior strategies, relaxation & sleep, diet, and pain.

Who is the study for?
This trial is for English-speaking individuals with a healthcare provider's diagnosis of inflammatory bowel disease (IBD), including Crohn's Disease and Ulcerative Colitis, who are currently experiencing symptoms. It's not open to those living outside Washington state or anyone who has had bowel-related surgery in the past month.
What is being tested?
The study tests a Comprehensive Self-Management (CSM) program adapted from one for irritable bowel syndrome. Over eight sessions, it covers IBD education, symptom tracking, cognitive strategies, relaxation techniques, sleep improvement tips, dietary guidance, and pain management.
What are the potential side effects?
Since this intervention involves educational and behavioral strategies rather than medication or medical procedures, side effects are minimal but may include discomfort discussing personal health issues or stress from trying new management techniques.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability
Intervention feasibility
Recruitment feasibility
Secondary study objectives
Change in Quality of Life
Change in Symptoms
Other study objectives
Fecal Calprotectin
Gut Microbiome
Index of Self-Regulation
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Usual care groupExperimental Treatment1 Intervention
The control group will receive standard care without the comprehensive self-management intervention.
Group II: Comprehensive Self-ManagementExperimental Treatment1 Intervention
The 8 week intervention is delivered online with a brief weekly check-in with a registered nurse.

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,831 Previous Clinical Trials
1,907,515 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
606 Previous Clinical Trials
10,378,662 Total Patients Enrolled
Kendra Kamp, PHD, RNPrincipal InvestigatorUniversity of Washington

Media Library

Comprehensive Self-Management Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05651542 — N/A
Crohn's Disease Clinical Trial 2023: Comprehensive Self-Management Intervention Highlights & Side Effects. Trial Name: NCT05651542 — N/A
Comprehensive Self-Management Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05651542 — N/A
Crohn's Disease Research Study Groups: Comprehensive Self-Management, Usual care group
~7 spots leftby Mar 2025
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