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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

Study 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.Check my eligibility
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.See study design
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

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

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
1,741 Previous Clinical Trials
1,847,712 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
580 Previous Clinical Trials
10,376,507 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor include individuals over the age of eighty-five?

"Patients of age 18 or over, but less than 75 years old can take part in this medical study."

Answered by AI

Is it possible to register for this research project?

"Qualified applicants for this trial must have been diagnosed with inflammatory bowel disease and be between 18-75 years of age. A total 54 participants are being accepted into the study."

Answered by AI

Are applications still open for this clinical research undertaking?

"Indeed, the information on clinicaltrials.gov confirms that this medical study is actively enrolling volunteers. It was first published on March 14th 2023 and later updated two days after. 54 participants are required to be sourced from a single site."

Answered by AI

How many individuals are engaged in this research endeavor?

"Affirmative. The clinical trial is actively recruiting, as indicated on the information available at clinicaltrials.gov. This research was posted for the first time on March 14th 2023 and subsequently edited two days later. A total of 54 participants are required to be enrolled from a single location."

Answered by AI
~25 spots leftby Mar 2025