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Recruiting
View on ClinicalTrials.gov

Testing Patient Navigator for patient navigation

Official title: Empowering Families of Migrant Children and Youth with Special Healthcare Needs

Co-design and Evaluation of a Patient Navigator Intervention for Migrant Children and Youth with Special Healthcare Needs (CYSHCN) Experiencing Care Transitions (MiNav Trial)

Condition: Patient NavigationSponsor: McGill University Health Centre/Research Institute of the McGill University Health CentreTarget enrollment: 324
  • 2 groups
  • Sites in Toronto and Montreal
  • Recruiting
Unity Health Toronto, Compass Clinic, Toronto, OntarioCIUSSS West-Central Montreal, Montreal, QuebecMontreal Children's Hospital, Montreal, Quebec

Interventions

  • Behavioural therapy

    Patient Navigator

    The patient navigator will meet the following requirements: a bachelor's degree in health or social sciences, or equivalent experiences; strong knowledge of the local health and social services system; trauma-informed care and cultural safety; strong interpersonal skills, ability to problem-solve, and autonomy; have prior experiences with migrant communities (including lived experiences) and working in healthcare setting. The navigator will be trained on topics related to their role, through case discussions, and role playing, as done in other navigator trials. Topics will include Indigenous cultural safety as applied to migrant health, systems navigation, care coordination, family-centred care, social determinants of health (health insurance, income supplements, etc.) and inequities, advanced communication and helping skills (e.g., motivational interviewing), ethics, privacy, and confidentiality, and others as determined through our co-design process.

Canadian Sites (3)

2 of 3 recruiting

  • CIUSSS West-Central Montreal

    Montreal, Quebec

    Recruiting
  • Montreal Children's Hospital

    Montreal, Quebec

    Recruiting
  • Unity Health Toronto, Compass Clinic

    Toronto, Ontario

    Not yet recruiting

Eligibility Criteria

See who this study is looking for5 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Primary caregiver of child/youth ≤18 years who is first- or second-generation migrant, defined as born outside of Canada or having parents born elsewhere, respectively (migrants include immigrants, resettled refugees, refugee claimants (asylum seekers), temporary workers or international students, and other individuals without formal immigration status (undocumented)).
  • +Children or youth with special health care needs, as defined by the CYSHCN Screener, which identifies children who are experiencing one or more functional limitation or service use due to a physical, emotional, behavioural, developmental, or other health condition that has lasted or is expected to last at least 12 months.
  • +Experiencing care transitions between at least 2 of the following: primary care, community-based care, secondary specialist care, and/or hospital-based (acute) care.

Exclusion

  • Caregiver living in Canada ≥10 years
  • Families who are receiving available peer navigation support at sites will be excluded to limit cross-overCrossoverEach participant receives both treatments in turn, in a set order.Read more → of interventions.
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is looking at how care is delivered and organised, rather than at a treatment itself.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Group A receives no study treatment and is followed for comparison.

Registry label: A: Usual Care

Group B receives Patient Navigator.

Registry label: B: Patient Navigator

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

One group of people involved — usually the participants — is not told which treatment is which.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives no study treatment at all, and is followed for comparison.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a maximum age of 18 years.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 324 people.

The study is currently expected to finish around August 2027.

The main measurement is taken over: Assessment will happen at baselineBaselineYour starting measurements, taken before treatment begins.Read more →, 6 months after the start of the intervention and at the end of the intervention, i.e., 12 months.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Barriers to Care (BCQ) — measured over Assessment will happen at baselineBaselineYour starting measurements, taken before treatment begins.Read more →, 6 months after the start of the intervention and at the end of the intervention, i.e., 12 months.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT06373588 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Patient NavigatorBehavioural

The patient navigator will meet the following requirements: a bachelor's degree in health or social sciences, or equivalent experiences; strong knowledge of the local health and social services system; trauma-informed care and cultural safety; strong interpersonal skills, ability to problem-solve, and autonomy; have prior experiences with migrant communities (including lived experiences) and working in healthcare setting. The navigator will be trained on topics related to their role, through case discussions, and role playing, as done in other navigator trials. Topics will include Indigenous cultural safety as applied to migrant health, systems navigation, care coordination, family-centred care, social determinants of health (health insurance, income supplements, etc.) and inequities, advanced communication and helping skills (e.g., motivational interviewing), ethics, privacy, and confidentiality, and others as determined through our co-design process.

From the trial registry — its own words, unedited.

What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives no study treatment and is followed for comparison.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

One group of people involved — usually the participants — is not told which treatment is which.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: Assessment will happen at baselineBaselineYour starting measurements, taken before treatment begins.Read more →, 6 months after the start of the intervention and at the end of the intervention, i.e., 12 months..

The study as a whole is currently expected to finish around 2027-08.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 324 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists 2 locations, including: Toronto, Ontario, Canada; Montreal, Quebec, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

The goal of this randomized controlled trial is to test if a patient navigator program improves healthcare experiences and outcomes for migrant families caring for a child or youth with special healthcare needs (i.e. chronic health condition). The main questions are, for migrant families with a child or youth with special healthcare needs: Does a patient navigator reduces barriers to care? Does a patient navigator improve care coordination, caregiver empowerment, caregiver stress and quality of life? What are the healthcare experiences for families with and without the patient navigator intervention? Participants will: * Receive the intervention, i.e., the patient navigator program, or continue with standard of care for 12 months * Fill out questionnaires at 3 time points on barriers to care, caregiver stress, care coordination, and their child's health

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.