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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months
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 moreAwards & 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.
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Who is running the clinical trial?
University of WashingtonLead Sponsor
1,814 Previous Clinical Trials
1,912,979 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
600 Previous Clinical Trials
10,377,719 Total Patients Enrolled
Kendra Kamp, PHD, RNPrincipal InvestigatorUniversity of Washington
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor diagnosed me with inflammatory bowel disease.I can describe my current health symptoms.I have had surgery related to my bowels in the last month.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Comprehensive Self-Management
- Group 2: Usual care group
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