Transition to Adulthood Through Coaching and Empowerment in Rheumatology (TRACER)

March 16, 2023 updated by: Michelle Batthish, McMaster University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

133

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Recruiting
        • McMaster Children's Hospital
        • Contact:
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • Children's Hospital at London Health Sciences Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Western University

Investigators

  • Principal Investigator: Michelle Batthish, MD, McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2022

Primary Completion (Anticipated)

April 1, 2025

Study Completion (Anticipated)

April 1, 2025

Study Registration Dates

First Submitted

September 13, 2022

First Submitted That Met QC Criteria

September 16, 2022

First Posted (Actual)

September 19, 2022

Study Record Updates

Last Update Posted (Actual)

March 20, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14499

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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