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.

NCT ID: NCT07317973

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2028-04-30

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.

Detailed Description

BACKGROUND: A new consortium funded by Breakthrough T1D Canada (formerly Juvenile Diabetes Research Foundation Canada) and the Canadian Institutes of Health Research (CIHR) is exploring childhood screening for risk of type 1 diabetes (T1D) in the general population in Canada. Childhood screening requires decision making on the part of parents and guardians.

OBJECTIVE: The aim of this study is to develop patient decision aids to support Canadian families facing T1D screening and monitoring-related decisions (whether to screen their children for T1D using genetic or antibody testing, whether to participate in trials investigating medicines to delay or prevent the onset of T1D) by co-designing, optimizing, and evaluating patient decision aids. Patient decision aids are structured tools-often in the form of websites or pamphlets-intended to complement and support shared decision making with health care professionals. They specifically support decision making by making the decision explicit, providing information on potential benefits and harms of each option, and helping people clarify what matters most to them pertaining to the decision.

METHODS: We will work with an advisory committee of parents and guardians from across Canada and with diverse backgrounds and perspectives to design the patient decision aids. We will then conduct user testing across Canada with both remote and in-person user testing options. Finally, we will conduct online randomized controlled trials of the final patient decision aids to ascertain their effects on measures of decision quality compared to standard materials.

RESULTS: We will assess five measures of decision quality: knowledge, decisional conflict, risk perceptions, decision intentions, and values congruence.

CONCLUSIONS: This project will deliver optimized, evidence-based patient decision aids designed to support Canadian families (i.e., parents/guardians) in making informed, values-congruent decisions about T1D screening, follow-up, and enrollment in clinical trials for their child(ren). Our final audience for this work will be parents and guardians across Canada. We plan to offer the patient decision aids in the screening program pilot study and eventually scale up dissemination of the decision aids through registration in a known decision aid repository (decisionaid.ohri.ca) and collaborations with public health agencies of participating provinces. We will seek inclusion in online patient portals where such options exist.

Conditions

Diabetes, Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Patient decision aid

Participants receive patient decision aid

Group Type: EXPERIMENTAL

Web-based patient decision aid

Intervention Type: 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.

Control

Participants receive standard materials

Group Type: ACTIVE_COMPARATOR

Standard materials

Intervention Type: OTHER

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

Interventions

Web-based patient decision aid

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.

Intervention Type: OTHER

Standard materials

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Holly Witteman, PhD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Central Contacts

Holly Witteman, PhD

Role: CONTACT

holly.witteman@fmed.ulaval.ca

418-656-2131

Other Identifiers

CanScreenT1D PtDAs

Identifier Type: -

Identifier Source: org_study_id