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Completed

NCT Number: NCT04693780

Randomized Controlled Trial of Citizen-targeted Evidence-based Resources

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster Health Forum Impact Lab

Hamilton, Ontario, L8S 4K1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Structured guide

Other

Structured guide

List

Other

List

Primary outcomes

  1. Website logins

    Time frame: Three months

    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)

Secondary outcomes

  1. Self-reported change in information usage

    Time frame: Baseline, 3 months, and 6 months

    Change in behaviour in regards to information usage collected through a questionnaire

  2. Clicks on resources

    Time frame: Three months before cross-over and three months after cross-over

    Clicks on resources included in the guide/list with data compiled through Google Analytics

  3. Time on website

    Time frame: Three months before cross-over and three months after cross-over

    Time on website with data compiled through Google Analytics

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 5, 2021
Registry last updated
Mar 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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