IBS - Irritable Bowel Syndrome
Conditions
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.
Interventions
OTHERvirtually 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.
OTHERIBS Group Online Session
IBS online group session run by Happy Bellies Nutrition
Sponsors
Nova Scotia Health Authority
Research Nova Scotia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage participation in group session | 5 months post-randomization | Percentage of participation for Online group session program run by Happy Bellies, Nutrition measured by how many participants contributed |
| Quality Adjusted Life Years | 5 months post-randomization | Quality adjusted life years as measured using the EQ 5D and client service receipt inventory |
| Number of Modules accessed | 5 months post-randomization | Number of Modules accessed for Online group session program run by Happy Bellies Nutrition |
| Number of Modules completed | 5 months post-randomization | Number of Modules completed for Online group session program run by Happy Bellies Nutrition |
| IBS Symptom Severity | 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. |
| IBS Specific Quality of Life | 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. |
| Patient Quality of Life | 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. |
| Total number Inpatient services in the last 3 months | 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. |
| Total number Outpatient appointments in the last 3 months | 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. |
| Volume of referrals to Dietician | 5 months post-randomization | Volume of referrals sent to the Virtual Dietician led 1 on 1 education session |
| Volume of referrals to Online Group Session | 5 months post-randomization | 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 | 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: 1. I feel confident managing my IBS 2. Overall, I was satisfied receiving dietary education through telehealth 3. It was easy to ask questions and get answers 4. I felt comfortable communicating with the dietitian using the telehealth system 5. It was easy to use the technology to access the services 6. I had no concerns about the privacy of my personal data 7. I would recommend this service to friends and family |
| Volume of 1 on 1 dietary consults completed | 5 months post-randomization | Volume of 1 on 1 dietary consults completed, records kept by study dieticians |
| Number of online modules competed for Online Group Session | 5 months post-randomization | Number of online modules competed for Online Group Session |
| Number of sessions compared to proposed | 5 months post-randomization | Number of virtual dietician led 1 on 1 education sessions compared to proposed |
Countries
Canada
Outcome results
None listed