Clinical trial NCT05721742: 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
Overall status: RECRUITING
Phase: NA
Conditions: IBS - Irritable Bowel Syndrome
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Research Nova Scotia
First posted: 2023-02-10
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: IBS Symptom Severity
timeFrame: Baseline
measure: IBS Symptom Severity
timeFrame: 5 months post-randomization
measure: IBS Specific Quality of Life
timeFrame: Baseline
measure: IBS Specific Quality of Life
timeFrame: 5 months post-randomization
measure: Patient Quality of Life
timeFrame: Baseline
measure: Patient Quality of Life
timeFrame: 5 months post-randomization
measure: Total number Inpatient services in the last 3 months
timeFrame: Baseline
measure: Total number Inpatient services in the last 3 months
timeFrame: 5 months post randomization
measure: Total number Outpatient appointments in the last 3 months
timeFrame: baseline
measure: Total number Outpatient appointments in the last 3 months
timeFrame: 5 months post randomization
measure: Volume of referrals to Dietician
timeFrame: 5 months post-randomization
measure: Volume of referrals to Online Group Session
timeFrame: 5 months post-randomization
measure: Patient satisfaction with the Virtual Dietician led 1 on 1 education session
timeFrame: 5 weeks post-randomization
measure: Volume of 1 on 1 dietary consults completed
timeFrame: 5 months post-randomization
measure: Number of online modules competed for Online Group Session
timeFrame: 5 months post-randomization
measure: Number of sessions compared to proposed
timeFrame: 5 months post-randomization
measure: Number of Modules accessed
timeFrame: 5 months post-randomization
measure: Number of Modules completed
timeFrame: 5 months post-randomization
measure: Percentage participation in group session
timeFrame: 5 months post-randomization
measure: Quality Adjusted Life Years
timeFrame: 5 months post-randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: N.S.
Study officials:
References: