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

Primary Purpose

IBS - Irritable Bowel Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
virtually administered dietitian consults for IBS patients.
IBS Group Online Session
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for IBS - Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    pre-existing online group education program for IBS

    virtual dietitian consults for IBS patients

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    Volume of referrals to Dietician
    Volume of referrals sent to the Virtual Dietician led 1 on 1 education session
    Volume of referrals to Online Group Session
    Volume of referrals sent to the online IBS group session, run by Happy Bellies Nutrition
    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
    Volume of 1 on 1 dietary consults completed
    Volume of 1 on 1 dietary consults completed, records kept by study dieticians
    Number of online modules competed for Online Group Session
    Number of online modules competed for Online Group Session
    Number of sessions compared to proposed
    Number of virtual dietician led 1 on 1 education sessions compared to proposed
    Number of Modules accessed
    Number of Modules accessed for Online group session program run by Happy Bellies Nutrition
    Number of Modules completed
    Number of Modules completed for Online group session program run by Happy Bellies Nutrition
    Percentage participation in group session
    Percentage of participation for Online group session program run by Happy Bellies, Nutrition measured by how many participants contributed
    Quality Adjusted Life Years
    Quality adjusted life years as measured using the EQ 5D and client service receipt inventory

    Secondary Outcome Measures

    Full Information

    First Posted
    February 1, 2023
    Last Updated
    February 15, 2023
    Sponsor
    Nova Scotia Health Authority
    Collaborators
    Research Nova Scotia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05721742
    Brief Title
    Evaluating the Impact of Including Virtual Dietary Education Within an Electronic Irritable Bowel Syndrome Pathway
    Official Title
    Evaluating the Impact of Including Virtual Dietary Education Within an Electronic Irritable Bowel Syndrome Pathway
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2023 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    March 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Nova Scotia Health Authority
    Collaborators
    Research Nova Scotia

    4. Oversight

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

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    IBS - Irritable Bowel Syndrome

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    76 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    pre-existing online group education program for IBS
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    virtual dietitian consults for IBS patients
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    virtually administered dietitian consults for IBS patients.
    Intervention Description
    Participants will receive virtual one on one consults with a dietitian who has training in the dietary management of IBS.
    Intervention Type
    Other
    Intervention Name(s)
    IBS Group Online Session
    Intervention Description
    IBS online group session run by Happy Bellies Nutrition
    Primary Outcome Measure Information:
    Title
    IBS Symptom Severity
    Description
    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.
    Time Frame
    Baseline
    Title
    IBS Symptom Severity
    Description
    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.
    Time Frame
    5 months post-randomization
    Title
    IBS Specific Quality of Life
    Description
    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.
    Time Frame
    Baseline
    Title
    IBS Specific Quality of Life
    Description
    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.
    Time Frame
    5 months post-randomization
    Title
    Patient Quality of Life
    Description
    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.
    Time Frame
    Baseline
    Title
    Patient Quality of Life
    Description
    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.
    Time Frame
    5 months post-randomization
    Title
    Total number Inpatient services in the last 3 months
    Description
    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.
    Time Frame
    Baseline
    Title
    Total number Inpatient services in the last 3 months
    Description
    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.
    Time Frame
    5 months post randomization
    Title
    Total number Outpatient appointments in the last 3 months
    Description
    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.
    Time Frame
    baseline
    Title
    Total number Outpatient appointments in the last 3 months
    Description
    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.
    Time Frame
    5 months post randomization
    Title
    Volume of referrals to Dietician
    Description
    Volume of referrals sent to the Virtual Dietician led 1 on 1 education session
    Time Frame
    5 months post-randomization
    Title
    Volume of referrals to Online Group Session
    Description
    Volume of referrals sent to the online IBS group session, run by Happy Bellies Nutrition
    Time Frame
    5 months post-randomization
    Title
    Patient satisfaction with the Virtual Dietician led 1 on 1 education session
    Description
    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
    Time Frame
    5 weeks post-randomization
    Title
    Volume of 1 on 1 dietary consults completed
    Description
    Volume of 1 on 1 dietary consults completed, records kept by study dieticians
    Time Frame
    5 months post-randomization
    Title
    Number of online modules competed for Online Group Session
    Description
    Number of online modules competed for Online Group Session
    Time Frame
    5 months post-randomization
    Title
    Number of sessions compared to proposed
    Description
    Number of virtual dietician led 1 on 1 education sessions compared to proposed
    Time Frame
    5 months post-randomization
    Title
    Number of Modules accessed
    Description
    Number of Modules accessed for Online group session program run by Happy Bellies Nutrition
    Time Frame
    5 months post-randomization
    Title
    Number of Modules completed
    Description
    Number of Modules completed for Online group session program run by Happy Bellies Nutrition
    Time Frame
    5 months post-randomization
    Title
    Percentage participation in group session
    Description
    Percentage of participation for Online group session program run by Happy Bellies, Nutrition measured by how many participants contributed
    Time Frame
    5 months post-randomization
    Title
    Quality Adjusted Life Years
    Description
    Quality adjusted life years as measured using the EQ 5D and client service receipt inventory
    Time Frame
    5 months post-randomization

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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