A Comprehensive Self-Management Intervention for Individuals With Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

Official title:

A Comprehensive Self-Management Intervention for Individuals With Inflammatory Bowel Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05651542
• Other study ID #: STUDY00015210
• Secondary ID: 1K23NR020044-01A
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: May 2024
• Source: University of Washington
• Contact: Kindra Clark-Snustad, DNP
• Phone: 206-543-9485
• Email: kclark-snustad[@]medicine.washington.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to test the feasibility, acceptability, and preliminary efficacy of a comprehensive self-management (CSM) intervention for people with inflammatory bowel disease (IBD). The CSM-IBD intervention is an adaption of the CSM intervention initially developed for individuals with irritable bowel syndrome. The intervention has eight sessions which cover an introduction to IBD, symptom tracking, cognitive behavioral strategies, relaxation, sleep, diet, and pain management.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Healthcare provider diagnosis of inflammatory bowel disease

• Report current symptoms

• Able to read and write in English

Exclusion Criteria:

• Live outside of Washington state

• Bowel-related surgery within the past month

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

Behavioral:
• Comprehensive Self-Management Intervention
In addition to standard care, participants receive content on self-management which includes cognitive behavioral therapy, relaxation, and diet. Weekly phone calls provide support for achieving the sessions goals.

Other:
• Control
The control group will receive standard care.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-Efficacy for Managing Chronic Disease	a 6-item self-report scale. Participants report ranging from not at all confident to totally confident.	Baseline, 3 months, 6 months
Other	Index of Self-Regulation	a 9-item scale to measure individual's level of self-regulation	Baseline, 3 months, 6 months
Other	Patient Activation Measure	a 13-item scale which assess patient's beliefs, knowledge and confidence in managing their health	Baseline, 3 months, 6 months
Other	Fecal Calprotectin	Level of fecal calprotectin assessed using ELISA.	Baseline, 3 months
Other	Gut Microbiome	Fecal microbial communities characterized using 16S rRNA gene sequencing on the Illumina MiniSeq platform (Illumina, Inc. Albany, New York)	Baseline, 3 months
Primary	Recruitment feasibility	Percentage comprised of number of participants enrolled divided by the number of participants approached.	From screening to enrollment
Primary	Intervention feasibility	Measured with the Feasibility of Intervention Measure (FIM) in which participants respond to four questions on a 5-point Likert scale from completely disagree (1) to completely agree (5).	3 months
Primary	Acceptability	A semi-structured interview guide will be used to assess acceptability of study procedures as well as acceptability and satisfaction with the intervention.	6 months
Secondary	Change in Quality of Life	Short Inflammatory Bowel Disease Questionnaire is a 10-item questionnaire which evaluates quality of life. Participants respond on a 7-item Likert scale from all the time to none of the time. Total score range: 10 to 70.	Baseline, 3 months, 6 months
Secondary	Change in Symptoms	Symptoms are measured using a numeric rating scale where participants report the severity of the symptom from not present (0) to worst possible (10). Symptoms include: abdominal pain, anxiety, bloating, constipation, depressed, diarrhea, fatigue/tiredness, passing gas, sleepiness during the day, stress, and urgency.	Baseline, 3 months, 6 months