Clinical trial NCT04693780: Randomized Controlled Trial of Citizen-targeted Evidence-based Resources
Official title: Randomized Controlled Trial of Citizen-targeted Evidence-based Resources for Patients, Family Members and Caregivers Seeking Health Information
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Irritable Bowel Syndrome
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2021-01-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Both the intervention and control groups will continue for three months. After three months, the control group will be sent a message highlighting some additions to the content provided to them. From his point forward when they login to the system they will be presented with the same content that was previously only available to the intervention group. Providing those in the control group access to the same material as the intervention group for a period of the study will allow for direct within- group comparison as well as a direct comparison between groups. Both groups will continue in this manner for an additional three months.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine whether an online resource developed to aid health consumers in making health decisions and better support them to seek quality evidence before other evidence is effective in the context of inflammatory bowel disease and irritable bowel syndrome

Detailed description: Participants who consent to participate in the study will be randomly allocated to either the intervention or control group.

Once logged into the website, participants in the intervention group will navigate health information through an annotated structured guide to health evidence (see Appendix 2) which is designed to inform participants where to find specific health information but it will also provide information to understand why such content is more valuable than other content. This structured annotated guide to evidence will also outline the value of pre-appraisal and will help them navigate to products produced for them. These products have been produced by the research team and include a collection of web resource ratings, evidence summaries and blog posts modelled after those developed and presented on the McMaster Optimal Aging Portal.

Once logged into the website, participants in the control group will navigate health information through a structured one-page guide (see Appendix 1) that does not include pre-appraisal information. Instead it will list the main organizations in the field that produce citizen content with descriptions of the type of content they produce with links to their individual websites. This will be presented to participants when they login to the platform. None of the citizen content produced specifically for the study will be provided to them prior to crossing-over.

All participants will receive periodic reminders to access the content in the form of an email sent every two weeks.

Both the intervention and control groups will continue for three months. After three months, the control group will be sent a message highlighting some additions to the content provided to them. From his point forward when they login to the system they will be presented with the same content that was previously only available to the intervention group. Providing those in the control group access to the same material as the intervention group for a period of the study will allow for direct within- group comparison as well as a direct comparison between groups. Both groups will continue in this manner for an additional three months.

Eligibility criteria: Inclusion Criteria:

* Patients, caregivers or family members
* Aged 18 and above
* Have lived experience with, and are seeking information about, any of inflammatory bowel disease (i.e. Crohn's disease and ulcerative colitis), or irritable bowel syndrome

The study may also include, but will not initial target/recruit, patients, caregivers or family members, aged 18 and above, who have lived experience with, and are seeking information about all other gastrointestinal conditions and their symptoms (including abdominal pain, bloating, constipation, cramping, diarrhea, fatigue, gas, loss of appetite, nausea, and stools with mucus), microbiome and metabolomics, and celiac disease.

Primary outcomes:
measure: Website logins
timeFrame: Three months
Secondary outcomes:
measure: Self-reported change in information usage
timeFrame: Baseline, 3 months, and 6 months
measure: Clicks on resources
timeFrame: Three months before cross-over and three months after cross-over
measure: Time on website
timeFrame: Three months before cross-over and three months after cross-over
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Health Forum Impact Lab
state: Ontario
Study officials:
References: