TRACER: Transition to Adulthood Through Coaching and Empowerment in Rheumatology

Sponsor

McMaster University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05545839

Collaborator

Western University (Other)

133

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Juvenile Idiopathic Arthritis Juvenile Rheumatoid Arthritis Juvenile Dermatomyositis Juvenile Psoriatic Arthritis Autoinflammatory Disease Autoimmune Diseases Lupus Erythematosus	Behavioral: Transition coaching	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

133 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

No Intervention: Standard care - control

Standard of care, appointments with adult rheumatology

Experimental: Transition coaching - experimental

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

Behavioral: Transition coaching

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.

Outcome Measures

Primary Outcome Measures

Consent rate [19 month recruitment period]
% of patients approached who consent to the study
Enrolment from non-primary site [19 month]
% of patients enrolled from non-primary site
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)
Missing data [3 year study period]
% of missing data

Secondary Outcome Measures

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
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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