A Study About Patient Decision Aids Designed to Help Parents and Guardians in Canada Make Evidence-informed, Values-congruent Decisions About Screening Children for Type 1 Diabetes and Follow-up Decisions.

NCT07317973 | Not Yet Recruiting

• 1 other identifier: CanScreenT1D PtDAs
• Study Type: interventional
• Target: 350
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will design and test patient decision aids to help parents and guardians in Canada make decisions about screening their children for type 1 diabetes. To do this, we will work with a panel of parents and guardians as well as scientific experts, show draft designs to parents and guardians, improve the draft designs based on feedback, and finally test the patient decision aids in online studies.

Conditions

Diabetes, Mellitus, Type 1

Outcome Measures

Primary Outcomes (2)

• Knowledge

  To assess knowledge, we will develop a questionnaire specific to the topic of screening for T1D based on previous work by the developers of the Ottawa Decision Support Framework \[https://decisionaid.ohri.ca/eval\_know.html\] and building on work conducted by members of the CanScreenT1D consortium to develop a core outcomes set relevant to T1D screening. \[https://doi.org/10.1136/bmjopen-2025-099537\] Answers to each question will receive a score of 1 (if the participant selects the correct answer "true" or "false") and 0 (if the answer is incorrect or if the participant answers "uncertain"). Items are totaled and an average knowledge score is calculated. For comparison with scales from 0 to 100, the score can be converted into a percentage of correct answers.

  Immediately post-intervention

• Decisional conflict

  To assess decisional conflict, we will use the validated 16-item Decisional Conflict scale. \[https://doi.org/10.1177/0272989X9501500105\] This scale measures personal perceptions of a) uncertainty in the choice of options; b) modifiable factors contributing to uncertainty, such as feelings of being uninformed, unclear about personal values and unsupported in decision-making; and c) decision-making effectiveness, such as feelings that the choice is informed, value-based, actionable and expressions of satisfaction with the choice.

  Immediately post-intervention

Secondary Outcomes (3)

• Risk perception

  Immediately post-intervention

• Values congruence

  Immediately post-intervention

• Decision intentions

  Immediately post-intervention

Study Arms (2)

Patient decision aid

EXPERIMENTAL

Participants receive patient decision aid

Other: Web-based patient decision aid

Control

ACTIVE COMPARATOR

Participants receive standard materials

Other: Standard materials

Interventions

Web-based patient decision aid OTHER

The web-based patient decision aid will provide information and support decisions relevant to screening children for type 1 diabetes and follow-up according to screening results.

Patient decision aid

Standard materials OTHER

Standard materials provided to parents whose children are eligible for type 1 diabetes screening and follow-up.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be 18 or older, live in Canada, be able to read and understand either English or French, and be able to use a computer. They must not have uncorrected visual and/or hearing impairments, currently have one or more children and be eligible to make a decision about T1D screening for a current (already born) or future (currently expected due to pregnancy) child.

You may not qualify if:

• All participants who do not complete the visualization of the tools for various reasons (lack of availability, strong emotions, internet connection problems, etc.) will be excluded from the study.

Sponsors & Collaborators

• Laval University: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Holly Witteman, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Holly Witteman, PhD

CONTACT

418-656-2131; holly.witteman@fmed.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 5, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: January 5, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: IPD and supporting information will be available following completion of the study and as long as the Borealis instance is available.
• Access Criteria: Anyone with internet access will be able to access it.