The TRACE Study: TRansition to Adulthood Through Coaching and Empowerment - A Pilot Randomized-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Feasibility criteria of pilot study assessed through percent enrolment and completion of program
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •- cannot communicate in English
研究组 & 干预措施
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.
干预措施: Transition Coach Intervention (Behavioral)
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.
干预措施: Standard of Care- Youth Transition Roadmap (Behavioral)
结局指标
主要结局
Feasibility criteria of pilot study assessed through percent enrolment and completion of program
时间窗: 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.
次要结局
- Preliminary effect of Transition Coach Intervention on changes in self-efficacy as assessed by PROMIS questionnaire for Managing Chronic Conditions- Managing Emotions(9 months)
- Preliminary effect of Transition Coach Intervention on changes in self-efficacy as assessed by PROMIS questionnaire for Managing Chronic Conditions- Managing Medications(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(9 months)
- Understand the perspective and experience of youth about the Transition Coach Intervention with a satisfaction questionnaire(9 months)
- Preliminary effect of Transition Coach Intervention on changes in self-efficacy as assessed by PROMIS questionnaire for Managing Chronic Conditions- Managing Symptoms(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(9 months)
- Preliminary effect of Transition Coach Intervention on changes in self-efficacy as assessed by PROMIS questionnaire for Informational Support(9 months)
- Understand the perspective and experience of youth about the Transition Coach Intervention with a focus group(9 months)