Clinical trial NCT05545839: Transition to Adulthood Through Coaching and Empowerment in Rheumatology
Official title: TRACER: Transition to Adulthood Through Coaching and Empowerment in Rheumatology, A Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Juvenile Idiopathic Arthritis
Juvenile Rheumatoid Arthritis
Juvenile Dermatomyositis
Juvenile Psoriatic Arthritis
Autoinflammatory Disease
Autoimmune Diseases
Lupus Erythematosus
Keywords: transition care
transition coaching
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Western University
First posted: 2022-09-19
Enrollment: 133
Sex: ALL
Minimum age (years): 17
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Consent rate
timeFrame: 19 month recruitment period
measure: Enrolment from non-primary site
timeFrame: 19 month
measure: Virtual session attendance
timeFrame: 3 year study period
measure: Outcome measure completion
timeFrame: 3 year study period
measure: Missing data
timeFrame: 3 year study period
Secondary outcomes:
measure: Patient Reported Outcomes Measurement Information System (PROMIS) questionnaire
timeFrame: 3 year study period
measure: Physician Global Assessment (PGA)
timeFrame: 3 year study period
measure: Active joint count
timeFrame: 3 year study period
measure: Global function/quality of life
timeFrame: 3 year study period
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: London
country: Canada
facility: Children's Hospital at London Health Sciences Centre
state: Ontario
Study officials:
affiliation: McMaster University
name: Michelle Batthish, MD
role: PRINCIPAL_INVESTIGATOR
References: