NCT06443190

Brief Summary

The objective of this pathway is to establish and evaluate a novel Indigenous-led patient navigator (IPN) program for Indigenous adolescents living with chronic health conditions in Maskwacis, Alberta. Over the last three years a community-based participatory research partnership was developed with Elders and community members from Maskwacis, Maskwacis Health Services, and researchers from the University of Alberta. Previous research identified the need for an IPN to support Indigenous young adults and their caregivers in managing their health conditions transitioning into adulthood and transferring from pediatric to adult healthcare. The aim of partnership now is to evaluate whether a community-derived IPN program co-designed with an established group of Maskwacis Elders, Knowledge Keepers, healthcare providers, caregivers and youth with lived experience can aid in improving the experience of transitioning into adult healthcare services for Indigenous youth and their families living in Maskwacis, Alberta.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
22mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress27%
Sep 2025Mar 2028

First Submitted

Initial submission to the registry

May 23, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 5, 2024

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

October 7, 2025

Status Verified

October 1, 2025

Enrollment Period

1.7 years

First QC Date

May 23, 2024

Last Update Submit

October 1, 2025

Conditions

Keywords

transitionIndigenouscommunity based participatory action researchhealth care navigator

Outcome Measures

Primary Outcomes (1)

  • Qualitative Analysis - Semi-structured interviews

    Participants will complete a follow-up semi-structured interview, held either in-person or virtually, conducted by the RA to ask about their experience receiving IPN support. Feedback will be elicited on what aspects of IPN support was helpful and what could be improved upon. Healthcare providers who work at clinic sites where recruitment took place will also be asked to take part in an individual interview about how the IPN service impacted their practice and care provision to Indigenous youth and their families. All interviews will be recorded and transcribed verbatim, and NVivo software will be used for analysis. Thematic analysis will be used to extrapolate and systematically analyze patterns in the data generated by the qualitative data.

    18 months

Secondary Outcomes (1)

  • Qualitative Analysis - Talking circles

    18 months

Study Arms (1)

Indigenous Patient Navigator Support

EXPERIMENTAL

Participants will work with an Indigenous Patient Navigator (IPN) for up to 18 months. The IPN may have the following roles in supporting the youth +/- their caregiver in managing their healthcare and health condition: * Spiritual: connect with community Elders, connect with cultural programs, arrange smudging and ceremony * Physical: find housing, find a family doctor, arrange transportation, fill prescriptions, create a health passport * Mental: arrange health benefits, schedule appointments, find employment, connect to community services * Emotional: connect with peers, find mental health supports, support youth at appointments, communicate with youth's healthcare team

Other: Indigenous Patient Navigator Support

Interventions

See Arm Description

Indigenous Patient Navigator Support

Eligibility Criteria

Age16 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age 16-25 years;
  • having chronic health condition of at least 3 months' duration that requires adult specialty follow-up care, including physical conditions (e.g., diabetes), mental health conditions (e.g., anxiety, depression), and/or developmental disorders (e.g., autism, fetal alcohol spectrum disorder);
  • residing in Maskwacis or from the communities of Maskwacis but currently residing elsewhere;
  • self-identified as an Indigenous person;
  • reading level ≥ grade 6. For participants with developmental or intellectual delay (\< grade 6 reading level), they may take part in the program alongside their caregiver(s).

You may not qualify if:

  • not identifying as Indigenous
  • not residing in Maskwacis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stollery Children's Hospital

Edmonton, Alberta, T6G 2R3, Canada

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2024

First Posted

June 5, 2024

Study Start

September 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

October 7, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations