NCT07838896

Brief Summary

The period leading up to and following transfer from pediatric to adult care for youth with rheumatic disease is a vulnerable time leaving youth at risk of poor self-efficacy (confidence in ability to manage all aspects of their health). Adult rheumatologists face barriers in providing the complex medical, developmental and socially supportive care required for this population. Youth have expressed preference for individualized coaching during this period which involves education and support around skills and confidence-building related to their disease. The investigators have completed a feasibility trial of a Transition Coach Intervention (TCI) to help youth with rheumatic diseases gain self-efficacy and better navigate transition to adult care. The investigators will now conduct a randomized-control trial (RCT) at six centres to demonstrate TCI efficacy.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
43mo left

Started Mar 2027

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

September 16, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 24, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2027

Expected
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2030

Last Updated

September 24, 2026

Status Verified

September 1, 2026

Enrollment Period

2.8 years

First QC Date

September 16, 2026

Last Update Submit

September 23, 2026

Conditions

Keywords

transition to adult healthcarehealth coachingrheumatologyyouth

Outcome Measures

Primary Outcomes (1)

  • PROMIS (Patient-Reported Outcomes Measurement Information System)

    Self-efficacy for managing chronic conditions - Self-efficacy is a "positively framed" domain. This means a higher T-score represents greater confidence in managing your condition.

    baseline, 8 and 11 months

Study Arms (2)

Transition coaching

EXPERIMENTAL

8 monthly sessions with a transition coach

Behavioral: transition coaching

Attention-control

NO INTERVENTION

Participants receive transition toolkit and 8-monthly phone calls with the research coordinator as a reminder of their participation in the study.

Interventions

8 monthly transition coaching sessions

Transition coaching

Eligibility Criteria

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

You may qualify if:

  • will be transferred to adult rheumatology care in the next 12 months

You may not qualify if:

  • do not expect to live independently

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

Central Study Contacts

Michelle Batthish, MD

CONTACT

Karen Beattie, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 16, 2026

First Posted

September 24, 2026

Study Start (Estimated)

March 1, 2027

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

September 1, 2030

Last Updated

September 24, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations