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

IBS - Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05721742
• Other study ID #: 53363
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2023
• Est. completion date: March 2025

Study information

• Verified date: May 2024
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• IBS - Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Intervention

Other:
• virtually administered dietitian consults for IBS patients.
Participants will receive virtual one on one consults with a dietitian who has training in the dietary management of IBS.
• IBS Group Online Session
IBS online group session run by Happy Bellies Nutrition

Locations

Country	Name	City	State
Canada	QEII Health Sciences Centre	Halifax	N.S.

Sponsors (2)

Lead Sponsor	Collaborator
Nova Scotia Health Authority	Research Nova Scotia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Volume of referrals to Dietician	Volume of referrals sent to the Virtual Dietician led 1 on 1 education session	5 months post-randomization
Primary	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
Primary	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
Primary	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
Primary	Number of online modules competed for Online Group Session	Number of online modules competed for Online Group Session	5 months post-randomization
Primary	Number of sessions compared to proposed	Number of virtual dietician led 1 on 1 education sessions compared to proposed	5 months post-randomization
Primary	Number of Modules accessed	Number of Modules accessed for Online group session program run by Happy Bellies Nutrition	5 months post-randomization
Primary	Number of Modules completed	Number of Modules completed for Online group session program run by Happy Bellies Nutrition	5 months post-randomization
Primary	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
Primary	Quality Adjusted Life Years	Quality adjusted life years as measured using the EQ 5D and client service receipt inventory	5 months post-randomization