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Clinical Trials/NCT05651542
NCT05651542
Completed
Not Applicable

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

University of Washington1 site in 1 country55 target enrollmentMarch 14, 2023

Overview

Phase
Not Applicable
Intervention
Comprehensive Self-Management Intervention
Conditions
Inflammatory Bowel Diseases
Sponsor
University of Washington
Enrollment
55
Locations
1
Primary Endpoint
Recruitment feasibility
Status
Completed
Last Updated
3 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
March 14, 2023
End Date
September 30, 2025
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kendra Kamp

Assistant Professor, Biobehavioral Nursing & Health Informatics

University of Washington

Eligibility Criteria

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

Arms & Interventions

Comprehensive Self-Management

The 8 week intervention is delivered online with a brief weekly check-in with a registered nurse.

Intervention: Comprehensive Self-Management Intervention

Usual care group

The control group will receive standard care without the comprehensive self-management intervention.

Intervention: Control

Outcomes

Primary Outcomes

Recruitment feasibility

Time Frame: From screening to enrollment

Percentage comprised of number of participants enrolled divided by the number of participants approached.

Intervention feasibility

Time Frame: 3 months

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).

Acceptability

Time Frame: 6 months

A semi-structured interview guide will be used to assess acceptability of study procedures as well as acceptability and satisfaction with the intervention.

Secondary Outcomes

  • Change in Quality of Life(Baseline, 3 months, 6 months)
  • Change in Symptoms(Baseline, 3 months, 6 months)

Study Sites (1)

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