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NCT Number: NCT05721742

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

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.

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Key information

Conditions

IBS - Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

QEII Health Sciences Centre

Halifax, N.S., B3H 3A7, Canada

Location status: Recruiting

Location contact

Jennifer L Jones, MD

CONTACT

[email protected]

902-473-1499

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

virtually administered dietitian consults for IBS patients.

Other

Participants will receive virtual one on one consults with a dietitian who has training in the dietary management of IBS.

IBS Group Online Session

Other

IBS online group session run by Happy Bellies Nutrition

Primary outcomes

  1. IBS Symptom Severity

    Time frame: Baseline

    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.

  2. IBS Symptom Severity

    Time frame: 5 months post-randomization

    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.

  3. IBS Specific Quality of Life

    Time frame: Baseline

    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.

  4. IBS Specific Quality of Life

    Time frame: 5 months post-randomization

    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. Patient Quality of Life

    Time frame: Baseline

    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.

  6. Patient Quality of Life

    Time frame: 5 months post-randomization

    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.

  7. Total number Inpatient services in the last 3 months

    Time frame: Baseline

    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.

  8. Total number Inpatient services in the last 3 months

    Time frame: 5 months post randomization

    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.

  9. Total number Outpatient appointments in the last 3 months

    Time frame: baseline

    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.

  10. Total number Outpatient appointments in the last 3 months

    Time frame: 5 months post randomization

    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.

  11. Volume of referrals to Dietician

    Time frame: 5 months post-randomization

    Volume of referrals sent to the Virtual Dietician led 1 on 1 education session

  12. Volume of referrals to Online Group Session

    Time frame: 5 months post-randomization

    Volume of referrals sent to the online IBS group session, run by Happy Bellies Nutrition

  13. Patient satisfaction with the Virtual Dietician led 1 on 1 education session

    Time frame: 5 weeks post-randomization

    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

  14. Volume of 1 on 1 dietary consults completed

    Time frame: 5 months post-randomization

    Volume of 1 on 1 dietary consults completed, records kept by study dieticians

  15. Number of online modules competed for Online Group Session

    Time frame: 5 months post-randomization

    Number of online modules competed for Online Group Session

  16. Number of sessions compared to proposed

    Time frame: 5 months post-randomization

    Number of virtual dietician led 1 on 1 education sessions compared to proposed

  17. Number of Modules accessed

    Time frame: 5 months post-randomization

    Number of Modules accessed for Online group session program run by Happy Bellies Nutrition

  18. Number of Modules completed

    Time frame: 5 months post-randomization

    Number of Modules completed for Online group session program run by Happy Bellies Nutrition

  19. Percentage participation in group session

    Time frame: 5 months post-randomization

    Percentage of participation for Online group session program run by Happy Bellies, Nutrition measured by how many participants contributed

  20. Quality Adjusted Life Years

    Time frame: 5 months post-randomization

    Quality adjusted life years as measured using the EQ 5D and client service receipt inventory

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Collaborators

  • Research Nova Scotia

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2023
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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