NCT05545839

Brief Summary

TRACER is a study aiming to investigate the feasibility of transition coaching sessions for patients moving from paediatric to adult rheumatology care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
28 days until next milestone

Study Start

First participant enrolled

October 17, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

2.5 years

First QC Date

September 13, 2022

Last Update Submit

February 9, 2026

Conditions

Keywords

transition caretransition coaching

Outcome Measures

Primary Outcomes (5)

  • Consent rate

    % of patients approached who consent to the study

    19 month recruitment period

  • Enrolment from non-primary site

    % of patients enrolled from non-primary site

    19 month

  • Virtual session attendance

    % of transition coaching sessions attended

    3 year study period

  • Outcome measure completion

    % of outcome assessments completed at 8 months (end of transition coach invention)

    3 year study period

  • Missing data

    % of missing data

    3 year study period

Secondary Outcomes (4)

  • Patient Reported Outcomes Measurement Information System (PROMIS) questionnaire

    3 year study period

  • Physician Global Assessment (PGA)

    3 year study period

  • Active joint count

    3 year study period

  • Global function/quality of life

    3 year study period

Study Arms (2)

Standard care - control

NO INTERVENTION

Standard of care, appointments with adult rheumatology

Transition coaching - experimental

EXPERIMENTAL

Participants will receive 8 transition coaching sessions (1/month) in addition to standard care

Behavioral: Transition coaching

Interventions

Transition coaching sessions (8 sessions), covering paediatric to adult care, self-advocacy, medication management, general health, lifestyle and behaviours, future planning, screening for mood disorders and coping skills.

Transition coaching - experimental

Eligibility Criteria

Age17 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patient with pediatic-onset rheumatic disease
  • At their last paediatric rheumatology appointment prior to transferring to adult rheumatology care
  • Able to communicate in English
  • Have a phone or device capable of participating in video conference
  • Available over the next 8 months

You may not qualify if:

  • Cognitive impairment preventing participation in individualized education sessions (as determined by medical staff)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

Children's Hospital at London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Conditions

Arthritis, JuvenileDermatomyositisAutoimmune Diseases

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesImmune System DiseasesPolymyositisMyositisMuscular DiseasesNeuromuscular DiseasesNervous System DiseasesSkin Diseases

Study Officials

  • Michelle Batthish, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 19, 2022

Study Start

October 17, 2022

Primary Completion

May 1, 2025

Study Completion

December 31, 2025

Last Updated

February 11, 2026

Record last verified: 2026-02

Locations