Transition to Adulthood Through Coaching and Empowerment in Rheumatology

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

Detailed Description
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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.

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

Conditions
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Juvenile Psoriatic Arthritis, Autoinflammatory Disease, Autoimmune Diseases, Juvenile Idiopathic Arthritis, Juvenile Rheumatoid Arthritis, Juvenile Dermatomyositis, Lupus Erythematosus

Intervention / Treatment
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* Behavioral: Transition coaching


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care - control<br>Standard of care, appointments with adult rheumatology | |
| Experimental: Transition coaching - experimental<br>Participants will receive 8 transition coaching sessions (1/month) in addition to standard care | Behavioral: Transition coaching<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcomes Measurement Information System (PROMIS) questionnaire | 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. | 3 year study period | 
| Physician Global Assessment (PGA) | 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 year study period | 
| Active joint count | 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 | 3 year study period | 
| Global function/quality of life | 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. | 3 year study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transition care, transition coaching