Transition to Adulthood Through Coaching and Empowerment in Rheumatology

Not Applicable

Recruiting

• Conditions: Juvenile Rheumatoid Arthritis; Autoimmune Diseases; Juvenile Dermatomyositis; Juvenile Psoriatic Arthritis; Autoinflammatory Disease; Juvenile Idiopathic Arthritis; Lupus Erythematosus
• Interventions: Behavioral: Transition coaching

• Registration Number: NCT05545839
• Lead Sponsor: McMaster University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-09-13
• Study First Submitted QC: 2022-09-16
• Study First Posted: 2022-09-19
• Study Start: 2022-10-17
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-20
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 133

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transition coaching - experimental	Transition coaching	Participants will receive 8 transition coaching sessions (1/month) in addition to standard care

Primary Outcome Measures

Name	Time	Method
Missing data	3 year study period	% of missing data
Consent rate	19 month recruitment period	% of patients approached who consent to the study
Virtual session attendance	3 year study period	% of transition coaching sessions attended
Outcome measure completion	3 year study period	% of outcome assessments completed at 8 months (end of transition coach invention)
Enrolment from non-primary site	19 month	% of patients enrolled from non-primary site

Secondary Outcome Measures

Name	Time	Method
Global function/quality of life	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.
Patient Reported Outcomes Measurement Information System (PROMIS) questionnaire	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.
Physician Global Assessment (PGA)	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).
Active joint count	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

Trial Locations

Locations (2)

McMaster Children's Hospital; 🇨🇦 Hamilton, Ontario, Canada

Children's Hospital at London Health Sciences Centre; 🇨🇦 London, Ontario, Canada