Randomized Controlled Trial of Citizen-targeted Evidence-based Resources

Inflammatory Bowel Diseases Clinical Trial

Official title:

Randomized Controlled Trial of Citizen-targeted Evidence-based Resources for Patients, Family Members and Caregivers Seeking Health Information

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04693780
• Other study ID #: 8180
• Status: Completed
• Phase: N/A
• Start date: April 19, 2021
• Est. completion date: October 18, 2021

Study information

• Verified date: March 2023
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 18, 2021
• Est. primary completion date: October 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Irritable Bowel Syndrome

Intervention

Other:
• Structured guide
Structured guide
• List
List

Locations

Country	Name	City	State
Canada	McMaster Health Forum Impact Lab	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Website logins	The primary outcome of the study is number of logins to the website that contains the health information (each log-in will be tracked using Google Analytics)	Three months
Secondary	Self-reported change in information usage	Change in behaviour in regards to information usage collected through a questionnaire	Baseline, 3 months, and 6 months
Secondary	Clicks on resources	Clicks on resources included in the guide/list with data compiled through Google Analytics	Three months before cross-over and three months after cross-over
Secondary	Time on website	Time on website with data compiled through Google Analytics	Three months before cross-over and three months after cross-over