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Completed

NCT Number: NCT05545839

Transition to Adulthood Through Coaching and Empowerment in Rheumatology

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

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Key information

Conditions

Juvenile Idiopathic Arthritis Arthritis Arthritis, Juvenile Autoimmune Diseases Autoinflammatory Disease Connective Tissue Diseases Dermatomyositis Immune System Diseases Joint Diseases Juvenile Dermatomyositis Juvenile Psoriatic Arthritis Juvenile Rheumatoid Arthritis Lupus Erythematosus Muscular Diseases Musculoskeletal Diseases Myositis Nervous System Diseases Neuromuscular Diseases Polymyositis Rheumatic Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

17 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster Children's Hospital, Hamilton, Ontario, Canada

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About this study

TRACER is a feasibility study investigating transition coaching for patients with rheumatic disease transferring from paediatric to adult rheumatology care. This is a vulnerable time in the patients' care and life as they are assuming more responsibility for their health and undergoing significant life transitions. There is risk for increased morbidity and mortality around this time if the patient are not well supported and if they do not stay engaged with care. This intervention aim to provide self-efficacy, self-management, coping skills and support to patients making the transition. This study aims to assess the feasibility of conducting a multi-centre randomized trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Transition coaching

Behavioral

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.

Primary outcomes

  1. Consent rate

    Time frame: 19 month recruitment period

    % of patients approached who consent to the study

  2. Enrolment from non-primary site

    Time frame: 19 month

    % of patients enrolled from non-primary site

  3. Virtual session attendance

    Time frame: 3 year study period

    % of transition coaching sessions attended

  4. Outcome measure completion

    Time frame: 3 year study period

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

  5. Missing data

    Time frame: 3 year study period

    % of missing data

Secondary outcomes

  1. Patient Reported Outcomes Measurement Information System (PROMIS) questionnaire

    Time frame: 3 year study period

    Descriptive statistics of PROMIS questionnaire (person-centered measures to assess how people feel and function) results at baseline, 8 months and 11 months, between the two groups.

  2. Physician Global Assessment (PGA)

    Time frame: 3 year study period

    Descriptive statistics of physical global assessment at baseline and at subsequent follow-up, between the two groups. Physician Global Assessment refers to MD assessment of disease activity and is rated between 0 (no disease activity) and 10 (most active disease).

  3. Active joint count

    Time frame: 3 year study period

    Descriptive statistics of active joint count (joints with evidence of active inflammation - including swelling, tenderness, loss of ROM) at baseline and at subsequent follow-up, between the two groups

  4. Global function/quality of life

    Time frame: 3 year study period

    Descriptive statistics of PedsQL (Paediatric Quality of Life Inventory) 4.0 Generic Core Scales Young Adult Version questionnaire results at baseline, 8 months and 11 months, between the two groups.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Western University

Registry information

Official study title

TRACER: Transition to Adulthood Through Coaching and Empowerment in Rheumatology, A Feasibility Study

Acronym: TRACER

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2022
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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