search
Back to results

Randomized Controlled Trial of Citizen-targeted Evidence-based Resources

Primary Purpose

Inflammatory Bowel Diseases, Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Structured guide
List
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Inflammatory Bowel Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • McMaster Health Forum Impact Lab

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Structured guide with pre-appraisal content

Listing without pre-appraisal content

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Self-reported change in information usage
Change in behaviour in regards to information usage collected through a questionnaire
Clicks on resources
Clicks on resources included in the guide/list with data compiled through Google Analytics
Time on website
Time on website with data compiled through Google Analytics

Full Information

First Posted
December 28, 2020
Last Updated
March 19, 2023
Sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR)
search

1. Study Identification

Unique Protocol Identification Number
NCT04693780
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 19, 2021 (Actual)
Primary Completion Date
October 18, 2021 (Actual)
Study Completion Date
October 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Structured guide with pre-appraisal content
Arm Type
Experimental
Arm Description
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.
Arm Title
Listing without pre-appraisal content
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Structured guide
Intervention Description
Structured guide
Intervention Type
Other
Intervention Name(s)
List
Intervention Description
List
Primary Outcome Measure Information:
Title
Website logins
Description
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)
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Self-reported change in information usage
Description
Change in behaviour in regards to information usage collected through a questionnaire
Time Frame
Baseline, 3 months, and 6 months
Title
Clicks on resources
Description
Clicks on resources included in the guide/list with data compiled through Google Analytics
Time Frame
Three months before cross-over and three months after cross-over
Title
Time on website
Description
Time on website with data compiled through Google Analytics
Time Frame
Three months before cross-over and three months after cross-over

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Are you: male female I do not identify as male or female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
McMaster Health Forum Impact Lab
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Randomized Controlled Trial of Citizen-targeted Evidence-based Resources

We'll reach out to this number within 24 hrs