Diabetes, Mellitus, Type 1NCT07317973
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.
A study testing Web-based patient decision aid and Standard materials in people with Diabetes, Mellitus, Type 1, run by Laval University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Mellitus, Type 1
- What is being tested?
- Web-based patient decision aid and Standard materials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Patient Decision Aids for Childhood Type 1 Diabetes Screening, Follow-Up, and Enrolment in Trials
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.
Read the 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
- Being tested
- Web-based patient decision aid, Standard materials
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based patient decision aidOther
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.
Standard materialsOther
Standard materials provided to parents whose children are eligible for type 1 diabetes screening and follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Patient decision aid | Experimental | Participants receive patient decision aid Receives: Other: Web-based patient decision aid |
| Control | Active comparator | Participants receive standard materials Receives: Other: Standard materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately post-intervention
Secondary outcomes (3)
Risk perception
Specifically, we will assess risk perception according to measures in the consortium core outcome set. [https://doi.org/10.1136/bmjopen-2025-099537]
Measured: Immediately post-intervention
Values congruence
Values congruence refers to the extent to which a decision aligns with one's personal values. To assess perceived values congruence, we will analyse the Values Clarity subscale of of the Decisional Conflict Scale. [https://doi.org/10.1177/0272989X9501500105] We will also analyse actual congruence between stated values measured prior to the decision on a visual analogue scale with the decision ultimately made.
Measured: Immediately post-intervention
Decision intentions
For decision intentions, we will elicit people's inclination or propensity to choose an option depending on the case (for example, getting one's child a genetic test or antibody tests, or enrolling one's child in follow-up activities such as participation in clinical trials.) We will use a 101-point visual analogue scale with labels at each extremity and in the middle. We will assign a value of -50 to one extremity, with a label such as, "will definitely not get my child tested for antibodies against type 1 diabetes," a value of 0 at the centre with a label such as, "unsure" and a value of +50 at the other extremity with a label such as, "will definitely get my child tested for antibodies against type 1 diabetes."
Measured: Immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Holly Witteman, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317973
- Sponsor's protocol ID
- CanScreenT1D PtDAs
- Status last verified
- Oct 2025
- First submitted
- 19 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share anonymized study data on Laval University's Dataverse (Borealis.)
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Decision Aids for Childhood Type 1 Diabetes Screening, Follow-Up, and Enrolment in Trials
- ClinicalTrials.gov ID
- NCT07317973
- Acronym / sponsor ID
- CanScreenT1D PtDAs
- Conditions
- Diabetes, Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient decision aid | Experimental | Other: Web-based patient decision aidParticipants receive patient decision aid |
| Control | Active comparator | Other: Standard materialsParticipants receive standard materials |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-based patient decision aidThe 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. | Other | Patient decision aid |
| Standard materialsStandard materials provided to parents whose children are eligible for type 1 diabetes screening and follow-up. | Other | Control |
Primary outcome
Knowledge
Time frame: Immediately post-intervention
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.
Decisional conflict
Time frame: Immediately post-intervention
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.
3 secondary outcomes
Risk perception
Time frame: Immediately post-intervention
Values congruence
Time frame: Immediately post-intervention
Decision intentions
Time frame: Immediately post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: Yes. We plan to share anonymized study data on Laval University's Dataverse (Borealis.)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Holly Witteman, PhD principal investigator
Laval University
Questions about this trial
What is this clinical trial studying?
A study testing Web-based patient decision aid and Standard materials in people with Diabetes, Mellitus, Type 1, run by Laval University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Holly Witteman, PhD (418-656-2131, holly.witteman@fmed.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge (time frame: Immediately post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.