Transition to Adulthood Through Coaching and Empowerment in Rheumatology

Autoimmune Diseases Clinical Trial

— TRACER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05545839
• Other study ID #: 14499
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2022
• Est. completion date: April 2025

Study information

• Verified date: March 2023
• Source: McMaster University
• Contact: Michelle Batthish, MD
• Phone: 1-905-521-2100
• Email: batthim[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 133
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Canada	McMaster Children's Hospital	Hamilton	Ontario
Canada	Children's Hospital at London Health Sciences Centre	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Western University

Country where clinical trial is conducted

Canada, 

Outcome

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