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

Primary Purpose

Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comprehensive Self-Management Intervention
Control
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Inflammatory Bowel Diseases focused on measuring IBD, UC, CD

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of WashingtonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Comprehensive Self-Management

Usual care group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Recruitment feasibility
Percentage comprised of number of participants enrolled divided by the number of participants approached.
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).
Acceptability
A semi-structured interview guide will be used to assess acceptability of study procedures as well as acceptability and satisfaction with the intervention.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 5, 2022
Last Updated
March 16, 2023
Sponsor
University of Washington
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT05651542
Brief Title
A Comprehensive Self-Management Intervention for Individuals With Inflammatory Bowel Disease
Official Title
A Comprehensive Self-Management Intervention for Individuals With Inflammatory Bowel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2023 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
Keywords
IBD, UC, CD

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Comprehensive Self-Management
Arm Type
Experimental
Arm Description
The 8 week intervention is delivered online with a brief weekly check-in with a registered nurse.
Arm Title
Usual care group
Arm Type
Other
Arm Description
The control group will receive standard care without the comprehensive self-management intervention.
Intervention Type
Behavioral
Intervention Name(s)
Comprehensive Self-Management Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
The control group will receive standard care.
Primary Outcome Measure Information:
Title
Recruitment feasibility
Description
Percentage comprised of number of participants enrolled divided by the number of participants approached.
Time Frame
From screening to enrollment
Title
Intervention feasibility
Description
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).
Time Frame
3 months
Title
Acceptability
Description
A semi-structured interview guide will be used to assess acceptability of study procedures as well as acceptability and satisfaction with the intervention.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in Quality of Life
Description
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.
Time Frame
Baseline, 3 months, 6 months
Title
Change in Symptoms
Description
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.
Time Frame
Baseline, 3 months, 6 months
Other Pre-specified Outcome Measures:
Title
Self-Efficacy for Managing Chronic Disease
Description
a 6-item self-report scale. Participants report ranging from not at all confident to totally confident.
Time Frame
Baseline, 3 months, 6 months
Title
Index of Self-Regulation
Description
a 9-item scale to measure individual's level of self-regulation
Time Frame
Baseline, 3 months, 6 months
Title
Patient Activation Measure
Description
a 13-item scale which assess patient's beliefs, knowledge and confidence in managing their health
Time Frame
Baseline, 3 months, 6 months
Title
Fecal Calprotectin
Description
Level of fecal calprotectin assessed using ELISA.
Time Frame
Baseline, 3 months
Title
Gut Microbiome
Description
Fecal microbial communities characterized using 16S rRNA gene sequencing on the Illumina MiniSeq platform (Illumina, Inc. Albany, New York)
Time Frame
Baseline, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kindra Clark-Snustad, DNP
Phone
206-543-9485
Email
kclark-snustad@medicine.washington.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kendra Kamp, PHD, RN
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kendra Kamp, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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