Randomized Controlled Trial of Citizen-targeted Evidence-based Resources

NCT04693780 | Completed

• 1 other identifier: 8180
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Inflammatory Bowel Diseases; Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Self-reported change in information usage

  Baseline, 3 months, and 6 months

• Clicks on resources

  Three months before cross-over and three months after cross-over

• Time on website

  Three months before cross-over and three months after cross-over

Study Arms (2)

Structured guide with pre-appraisal content

EXPERIMENTAL

Once logged into the website, participants in the intervention group will navigate health information through an annotated structured guide to health evidence 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. The topics of this citizen content match the scope of the IMAGINE Network.

Other: Structured guide

Listing without pre-appraisal content

PLACEBO COMPARATOR

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.

Other: List

Interventions

Structured guide OTHER

Structured guide

Structured guide with pre-appraisal content

List OTHER

List

Listing without pre-appraisal content

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Are you: 1. male 2. female 3. I do not identify as male or female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

McMaster Health Forum Impact Lab

Hamilton, Ontario, L8S 4K1, Canada

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colonic Diseases, Functional; Colonic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Once randomized, each participant will be allocated to their respective group by the website programmers who will allocate based on identification number and will not be privy to personal information regarding the participants.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: January 5, 2021
• Study Start: April 19, 2021
• Primary Completion: October 18, 2021
• Study Completion: October 18, 2021
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)