Evaluating the Impact of Including Virtual Dietary Education Within an Electronic Irritable Bowel Syndrome Pathway

Study Overview
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Brief Summary
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Irritable bowel syndrome is a functional bowel disorder that affects many Canadians. The syndrome involves abdominal pain and change in frequency or form of bowel movements, and these symptoms can lead to a decreased quality of life for patients. Primary care physicians are dissatisfied with current referral processes, and patients may wait a long time to receive the correct diagnosis. Diet is known to exacerbate symptoms of IBS. In Canada, accessing dietary treatment for IBS is a challenge due to lack of resources. Some patients lack access to dietary interventions, and others are given advice that is not evidenced based. Use of eHealth technology, such as virtual education delivered by a dietician, may allow for more widespread access to dietary interventions for IBS. Virtual education can include one on one dietary education, online group-based education, and the use of apps. Currently, there is a gap in knowledge whether dietary intervention for IBS, delivered virtually by a dietician, is effective in treating IBS.

Official Title
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Evaluating the Impact of Including Virtual Dietary Education Within an Electronic Irritable Bowel Syndrome Pathway

Conditions
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IBS - Irritable Bowel Syndrome

Intervention / Treatment
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* Other: virtually administered dietitian consults for IBS patients.
* Other: IBS Group Online Session


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recurrent abdominal pain on average at least 1 day/ week in the last 3 months associated with two or more of the following criteria: related to defecation, or association with a change in frequency of stool or associated with a change in form (appearance) of stool Willingness to change diet Access to a device for accessing virtual dietary education Exclusion Criteria: New onset symptoms within past year in age 50 and above Rectal bleeding Inflammatory Bowel Disease Unexplained recent weight loss Gastrointestinal surgery with removal of gallbladder or segments of the bowel Having an eating disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: pre-existing online group education program for IBS<br>This arm will be enrolled in the online course run by Happy Bellies Nutrition https://www.happybelliesnutrition.com/ibs-gentle-group-program. The Happy Bellies nutrition course has 5.5 hours of total video content and optional biweekly group calls via Zoom (45-minutes per session). This course is designed to take 12 weeks to complete. The participants would have access to the content for one year. | Other: IBS Group Online Session<br>* IBS online group session run by Happy Bellies Nutrition<br>|
| Experimental: virtual dietitian consults for IBS patients<br>This arm will receive consults with a virtual dietitian (60 minutes initial + 4 x30-minute follow-up appointment) by a dietitian who has had additional training in the dietary management of IBS. | Other: virtually administered dietitian consults for IBS patients.<br>* Participants will receive virtual one on one consults with a dietitian who has training in the dietary management of IBS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IBS Symptom Severity | IBS Symptom Severity as measured by the IBS Symptom Severity Score. Minimum: 75, Maximum: >300. Mild, moderate and severe cases are indicated by scores of 75 to 175, 175 to 300 and > 300 respectively. | Baseline | 
| IBS Symptom Severity | IBS Symptom Severity as measured by the IBS Symptom Severity Score. Minimum: 75, Maximum: >300. Mild, moderate and severe cases are indicated by scores of 75 to 175, 175 to 300 and > 300 respectively. | 5 months post-randomization | 
| IBS Specific Quality of Life | IBS Specific Quality of Life as measured by the IBS Quality of Life Questionnaire. Minimum: 0, Maximum: 100. Higher scores indicating better IBS specific quality of life. | Baseline | 
| IBS Specific Quality of Life | IBS Specific Quality of Life as measured by the IBS Quality of Life Questionnaire. Minimum: 0, Maximum: 100. Higher scores indicating better IBS specific quality of life. | 5 months post-randomization | 
| Patient Quality of Life | Patient Quality of Life as measured by the EQ 5D 5L Questionnaire. This questionnaire comprises the following five dimensions (ie. five questions): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension (question) has 5 levels (possible answers): 1-no problems, 2-slight problems, 3-moderate problems, 4-severe problems and 5-extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement. This results in a 1-digit number that expresses the level selected for that dimension, and the digits for the five dimensions are combined into a 5-digit number that describes the patient's health state. There is also a visual analog scale which asks the patient to rate their overall health from 0-100, with 0 being the worst, and 100 being best possible health. | Baseline | 
| Patient Quality of Life | Patient Quality of Life as measured by the EQ 5D 5L Questionnaire. This questionnaire comprises the following five dimensions (ie. five questions): mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension (question) has 5 levels (possible answers): 1-no problems, 2-slight problems, 3-moderate problems, 4-severe problems and 5-extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement. This results in a 1-digit number that expresses the level selected for that dimension, and the digits for the five dimensions are combined into a 5-digit number that describes the patient's health state. There is also a visual analog scale which asks the patient to rate their overall health from 0-100, with 0 being the worst, and 100 being best possible health. | 5 months post-randomization | 
| Total number Inpatient services in the last 3 months | Total number of inpatient services (admissions) in the last 3 months the patient has received, using an adaptation of the Client Services Receipt Inventory (CSRI). The PI will create a questionnaire containing the Service Receipt (Section 4) questions of the CSRI. | Baseline | 
| Total number Inpatient services in the last 3 months | Total number of inpatient services (admissions) in the last 3 months the patient has received, using an adaptation of the Client Services Receipt Inventory (CSRI). The PI will create a questionnaire containing the Service Receipt (Section 4) questions of the CSRI. | 5 months post randomization | 
| Total number Outpatient appointments in the last 3 months | Total number of outpatient services (outpatient appointments) in the last 3 months the patient has received, using an adaptation of the Client Services Receipt Inventory (CSRI). The PI will create a questionnaire containing the Service Receipt (Section 4) questions of the CSRI. | baseline | 
| Total number Outpatient appointments in the last 3 months | Total number of outpatient services (outpatient appointments) in the last 3 months the patient has received, using an adaptation of the Client Services Receipt Inventory (CSRI). The PI will create a questionnaire containing the Service Receipt (Section 4) questions of the CSRI. | 5 months post randomization | 
| Volume of referrals to Dietician | Volume of referrals sent to the Virtual Dietician led 1 on 1 education session | 5 months post-randomization | 
| Volume of referrals to Online Group Session | Volume of referrals sent to the online IBS group session, run by Happy Bellies Nutrition | 5 months post-randomization | 
| Patient satisfaction with the Virtual Dietician led 1 on 1 education session | Patient satisfaction with the Virtual Dietician led 1 on 1 education session measured via questionnaires that were written by the study PI. The following statements will be presented, answers will follow a 5-point Likert scale where 1-strongly disagree 2-disagree 3-neutral 4-agree 5-strongly agree: I feel confident managing my IBS Overall, I was satisfied receiving dietary education through telehealth It was easy to ask questions and get answers I felt comfortable communicating with the dietitian using the telehealth system It was easy to use the technology to access the services I had no concerns about the privacy of my personal data I would recommend this service to friends and family | 5 weeks post-randomization | 
| Volume of 1 on 1 dietary consults completed | Volume of 1 on 1 dietary consults completed, records kept by study dieticians | 5 months post-randomization | 
| Number of online modules competed for Online Group Session | Number of online modules competed for Online Group Session | 5 months post-randomization | 
| Number of sessions compared to proposed | Number of virtual dietician led 1 on 1 education sessions compared to proposed | 5 months post-randomization | 
| Number of Modules accessed | Number of Modules accessed for Online group session program run by Happy Bellies Nutrition | 5 months post-randomization | 
| Number of Modules completed | Number of Modules completed for Online group session program run by Happy Bellies Nutrition | 5 months post-randomization | 
| Percentage participation in group session | Percentage of participation for Online group session program run by Happy Bellies, Nutrition measured by how many participants contributed | 5 months post-randomization | 
| Quality Adjusted Life Years | Quality adjusted life years as measured using the EQ 5D and client service receipt inventory | 5 months post-randomization |