- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05570617
Transition to Adulthood Through Coaching and Empowerment (TRACE)
The TRACE Study: TRansition to Adulthood Through Coaching and Empowerment - A Pilot Randomized-Controlled Trial
Pediatric patients with Juvenile Idiopathic Arthritis or Inflammatory Bowel Disease who are preparing to transition into adult care face many unique challenges, and, to date, there is no comprehensive and implementable model of transition care in Canada or the United States. These patients, in addition to the systemic inflammatory nature of their diseases, are also in a period of immense psycho-social stress due to changes in school structure, employment, and general psycho-social growth. A poorly managed transition can have adverse effects on the quality and experience of care as well as contribute to poor disease outcomes including increased morbidity and even mortality.
The goal of this study is to determine the feasibility of using a transition coach intervention to help patients in their transition from pediatric to adult care.
Study Overview
Status
Intervention / Treatment
Detailed Description
This pilot, feasibility study aims to investigate a new approach to transition from pediatric to adult healthcare for Juvenile Idiopathic Arthritis or Inflammatory Bowel Disease patients.
The study population that will be recruited are 16-17-year-olds with Juvenile Idiopathic Arthritis or Inflammatory Bowel Disease seen in pediatric rheumatology or Gastroenterology clinics.
Upon consent, the patients will be asked by the study coordinator about their preferred method of communication (email or phone). Participants will then be randomly allocated to the Transition Coach Intervention or the control group (standard of care) using the Robust Randomization App using variable permuted block randomization (4 or 6) and a 1:1 allocation ratio. All participants will receive the Youth Transition Roadmap (standard of care) which discusses 5 domains of healthcare transition; Self-Advocacy, Medication Management, General Health, Lifestyle Issues and Future Planning related to education and vocation. The study coordinator will then invite the patients to complete a baseline study questionnaire on the online REDCap secure platform. This baseline questionnaire will gather information to describe our study population including: age, sex, disease type, age at diagnosis, family history, comorbidities and education stream. The investigators will also collect information regarding 'attitude towards transition' and 'feeling ready' for transition using questionnaire.
Once the patient has given informed consent and baseline demographic data has been collected, patients will be asked to complete the following questionnaires using REDCap: i) PedsQL™ 4.0 Generic Scale (18-25 year-old) to measure physical, emotional, social, and school functioning; ii) Patient Global Assessment, a measure of disease activity; and iii) Patient-Reported Outcomes Measurement Information System (PROMIS®) Self-Efficacy outcomes for Chronic Disease including Self-Efficacy for Managing Daily Activities v1.0, Emotions v1.0, Managing Medications and Treatments v1.0, Social Interactions v1.0, Symptoms v1.0, and Informational Support v2.0.
Individuals in the Transition Coach Intervention group will meet with the transition coach six times and with a clinical psychologist two times over the course of six months. The Transition Coach Intervention will include 8, 1-hour sessions over 6-months. The transition coach will independently meet one-on-one with each youth using an individualized, patient-centred approach beginning with an introductory session, followed by 5 sessions covering each topic in the Youth Transition Roadmap.
Upon completing the Transition Coach Intervention, two groups of 4-6 participants each will be randomly selected to participate in an Emotional Mapping exercise to share their experiences/satisfaction with the Transition Coach Intervention. Quality Improvement methods will be employed by Hamilton Health Science's Patient Experience office to yield an Emotional Map to inform modifications to the intervention for a future study
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michelle Batthish, MD
- Phone Number: 75382 905-525-9140
- Email: batthim@mcmaster.ca
Study Contact Backup
- Name: Karen Beattie, PhD
- Phone Number: 9055371683
- Email: beattik@mcmaster.ca
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N 3Z5
- Recruiting
- McMaster Children's Hospital
-
Contact:
- Michelle Batthish, MD
- Phone Number: 75382 1-905-521-2100
- Email: batthim@mcmaster.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 16-17-year-old Juvenile Idiopathic Arthritis or Inflammatory Bowel Disease patients
- can communicate in English
- have access to a phone (or other communication technology such as a laptop),
- are available over the 9-month follow-up period
Exclusion Criteria:
- cannot communicate in English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Transition Coach Intervention
Half (53) of the participants will be randomly allocated to the Transition Coach Intervention arm of the study.
Individuals in the Transition Coach Intervention group will receive the current standard of care (receiving the Youth Transition Roadmap) and meet with the transition coach six times and with a clinical psychologist two times over the course of six months.
The meetings between the participant and TC/psychologist will occur over the phone or using the Ontario Telemedicine Network or EPIC.
|
The Transition Coach Intervention will include 8, 1-hour sessions over 6-months.
The transition coach will independently meet one-on-one with each youth using an individualized, patient-centred approach beginning with an introductory session, followed by 5 sessions covering each topic in the Youth Transition Roadmap.
These topics include: Self-Advocacy, Medication Management, General Health, Lifestyle Issues and Future Planning related to education and vocation.
The clinical psychologist will lead 2 sessions beginning with the Patient Health Questionnaire for Anxiety and Depression as a screening tool.
The clinical psychologist will discuss psychological and social well-being in the context of their disease covering personally relevant issues/concerns.
|
Active Comparator: Standard of Care
The other half of participants will only receive the current standard of care is the Youth Transition Roadmap which has been developed by Hamilton Health Sciences and provides patients information about 5 domains of healthcare transition; Self-Advocacy, Medication Management, General Health, Lifestyle Issues and Future Planning related to education and vocation.
|
All participants will receive the Youth Transition Roadmap (standard of care) which discusses 5 domains of healthcare transition; Self-Advocacy, Medication Management, General Health, Lifestyle Issues and Future Planning related to education and vocation.
This is an informational pamphlet and will not require any additional meetings with the patient beyond their normal healthcare interactions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility criteria of pilot study assessed through percent enrolment and completion of program
Time Frame: 9 months
|
To determine the proportion of study participants who will attend at least 6 of 8 (80%) sessions of the Transition Coach Intervention aimed at improving self-efficacy and self-management skills.
To determine the number of patients that cannot consent because of the English language barrier, speech, language, hearing, or visual disability barriers, or technology barrier.
To determine the number of patients who consent from the total eligible patients approached.
To determine the number of outcome assessments completely and how many data items are missing from the data collection forms.
Finally, to determine the number of participants which are satisfied with the number of appointments and timeline of the Transition Coach Intervention.
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preliminary effect of Transition Coach Intervention on changes in self-efficacy as assessed by PROMIS questionnaire for Managing Chronic Conditions- Managing Emotions
Time Frame: 9 months
|
Descriptive statistics will summarize patient characteristics and clinical outcomes at each time point.
The investigators will describe within-person, within-group and between-group changes in PROMIS® outcomes in both groups using means and standard deviations or medians and interquartile ranges as appropriate.
|
9 months
|
Preliminary effect of Transition Coach Intervention on changes in self-efficacy as assessed by PROMIS questionnaire for Managing Chronic Conditions- Managing Medications
Time Frame: 9 months
|
Descriptive statistics will summarize patient characteristics and clinical outcomes at each time point.
The investigators will describe within-person, within-group and between-group changes in PROMIS® outcomes in both groups using means and standard deviations or medians and interquartile ranges as appropriate.
|
9 months
|
Preliminary effect of Transition Coach Intervention on changes in self-efficacy as assessed by PROMIS questionnaire for Managing Chronic Conditions- Managing Social Interactions
Time Frame: 9 months
|
Descriptive statistics will summarize patient characteristics and clinical outcomes at each time point.
The investigators will describe within-person, within-group and between-group changes in PROMIS® outcomes in both groups using means and standard deviations or medians and interquartile ranges as appropriate.
|
9 months
|
Preliminary effect of Transition Coach Intervention on changes in self-efficacy as assessed by PROMIS questionnaire for Managing Chronic Conditions- Managing Symptoms
Time Frame: 9 months
|
Descriptive statistics will summarize patient characteristics and clinical outcomes at each time point.
The investigators will describe within-person, within-group and between-group changes in PROMIS® outcomes in both groups using means and standard deviations or medians and interquartile ranges as appropriate.
|
9 months
|
Preliminary effect of Transition Coach Intervention on changes in self-efficacy as assessed by PROMIS questionnaire for Managing Chronic Conditions- Managing Daily Activities
Time Frame: 9 months
|
Descriptive statistics will summarize patient characteristics and clinical outcomes at each time point.
The investigators will describe within-person, within-group and between-group changes in PROMIS® outcomes in both groups using means and standard deviations or medians and interquartile ranges as appropriate.
|
9 months
|
Preliminary effect of Transition Coach Intervention on changes in self-efficacy as assessed by PROMIS questionnaire for Informational Support
Time Frame: 9 months
|
Descriptive statistics will summarize patient characteristics and clinical outcomes at each time point.
The investigators will describe within-person, within-group and between-group changes in PROMIS® outcomes in both groups using means and standard deviations or medians and interquartile ranges as appropriate.
|
9 months
|
Understand the perspective and experience of youth about the Transition Coach Intervention with a satisfaction questionnaire
Time Frame: 9 months
|
Measuring all the participants satisfaction with the Transition Coach Intervention by asking participants to fill in a satisfaction questionnaire asking about the appropriate number of meetings, length of meetings, and the types of topics discussed.
The investigators will describe within-person, within-group and between-group changes in satisfaction in both groups using means and standard deviations or medians and interquartile ranges as appropriate.
|
9 months
|
Understand the perspective and experience of youth about the Transition Coach Intervention with a focus group
Time Frame: 9 months
|
Measuring the participants satisfaction with the Transition Coach Intervention by asking participants to join a focus group to do an Emotional Mapping feedback exercise.
This will be done by two groups of 5-7 participants (one group of Juvenile Idiopathic Arthritis patients and another of Inflammatory Bowel Disease patients), randomly selected to share their experiences/satisfaction with the Transition Coach Intervention.
The responses from the Emotional Mapping exercise will inform modifications to the intervention in the future study.
|
9 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRACE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Inflammatory Bowel Diseases
-
University of British ColumbiaCompletedInflammatory Bowel Disease 11Canada
-
University of ChicagoTerminatedInflammatory Bowel Disease (IBD)United States
-
Centre Hospitalier Universitaire, AmiensFunding from DGOS (PHRC IR 2013 and PRME)CompletedPediatric Inflammatory Bowel DiseaseFrance
-
University of Wisconsin, MadisonTerminatedInflammatory Bowel Disease (IBD)United States
-
Cedars-Sinai Medical CenterUnknownPediatric Inflammatory Bowel Disease
-
University of Wisconsin, MadisonCompletedInflammatory Bowel Disease (IBD)United States
-
Assiut UniversityNot yet recruitingIBD-Inflammatory Bowel Disease
-
Icahn School of Medicine at Mount SinaiNorthwestern University; The Cleveland Clinic; University of California, Davis; RxHealt...RecruitingInflammatory Bowel Disease (IBD)United States
-
Nemours Children's ClinicNASPGHAN FoundationCompletedInflammatory Bowel Disease (IBD)United States
-
Hull University Teaching Hospitals NHS TrustWellcome/EPSRC Centre for Interventional and Surgical Sciences, University...RecruitingInflammatory Bowel Disease 1United Kingdom
Clinical Trials on Transition Coach Intervention
-
Cambridge Health AllianceCompletedPatient DischargeUnited States
-
Johns Hopkins UniversityAgency for Healthcare Research and Quality (AHRQ)CompletedFrail Elderly | Transitional Care | Home Health CareUnited States
-
McMaster UniversityCompletedEating Disorders | Eating Disorders in AdolescenceCanada
-
University of KansasCompletedType 1 DiabetesUnited States
-
Virginia Commonwealth UniversityAmerican Diabetes AssociationCompletedType 1 DiabetesUnited States
-
University of PennsylvaniaCompletedGeneral Medical Inpatient ConditionsUnited States
-
Wake Forest University Health SciencesNational Heart, Lung, and Blood Institute (NHLBI)Recruiting
-
East Carolina UniversityVidant Medical CenterCompletedMedication AdherenceUnited States
-
Universitaire Ziekenhuizen KU LeuvenCompleted
-
University of Alabama at BirminghamUS Department of Veterans Affairs; University of California, San Francisco; University...CompletedChronic Obstructive Pulmonary Disease | Congestive Heart FailureUnited States