The Effect of Joint Transition Visits on Quality of Life in Inflammatory Bowel Diseases (TRANS-IBD)

Study Overview
=================
Brief Summary
-----------------
Inflammatory bowel diseases (IBD) are among the most common chronic illnesses diagnosed in childhood. Moving from the pediatric to the adult health care is a crucial phase, which can greatly affect adolescents' quality of life. According to the latest international guidelines, based in particular on expert opinions, the implementation of joint visits (involving both pediatric and adult gastroenterologists) are highly recommended during the transition period. This trial aims to prove the beneficial effect of the joint visits.

Detailed Description
-----------------
Transition care is a targeted, well-planned activity, which aims to facilitate the transfer of adolescents with chronic illnesses from pediatric to adult health care. Over the past few years, several recommendations have been introduced with respect to the transitional care of adolescents with inflammatory bowel disease (IBD). According to the international recommendations, joint visits (involving both pediatric and adult gastroenterologists) are highly recommended during the transition period. Although joint visits are considered to be the most optimal form of structured transition, so far, no randomized controlled trial providing strong scientific evidence to prove the superiority of joint visits over usual care has been conducted. TRANS-IBD is a prospective, multicenter, randomized, controlled clinical trial designed to demonstrate the benefits of a structured transitional intervention involving joint visits. Patients in the intervention arm attend a total of four joint visits between the ages of 17 and 18. In the control arm, patients only meet the pediatric gastroenterologist but there is balanced consultation between the adult and the pediatric gastroenterologist, regarding the patient's medical history and treatment plan. Patients in both groups receive the same training and education, the only difference between the two arms is the presence of the adult gastroenterologist at the joint visits. The intervention period of the study starts at the age of 17 and lasts until the age of 18, when the participants are transferred to the adult gastroenterologist. The follow-up period starts from transfer and lasts until the end of the first year spent in the adult gastroenterology care.

Official Title
-----------------
The Effect of Joint Transition Visits on Quality of Life in Adolescents With Inflammatory Bowel Diseases: a Protocol for a Prospective, Randomized, Multicentre, Controlled Trial (TRANS-IBD)

Conditions
-----------------
Inflammatory Bowel Diseases, Crohn's Disease, Ulcerative Colitis

Intervention / Treatment
-----------------
* Other: joint visits


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: established IBD diagnosis based on the modified Porto Criteria at least 6 months prior to enrolment (date of the diagnostic endoscopy) any form of IBD (including Crohn's disease or ulcerative colitis) regardless of disease activity and treatment patient aged between 16.75 and 17 years at allocation at least one visit attendance at the pediatric gastroenterologist in the year prior to enrolment (aiming to minimize non-adherence with the intervention) signed written informed consent from the legal guardian and informed assent from the patients Exclusion Criteria: diagnosis of unclassified IBD (IBD-U) pregnancy medically certified developmental or intellectual disabilities (when it is expected that the patient is unable to fill the questionnaires) history of cancer or active cancer treatment BMI ≥ 40 concomitant participation in another interventional clinical trial conditions when follow-up cannot be fulfilled (e.g., plan for studying or working abroad after the age of 18)

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a randomized, controlled, two-arm, multicentre trial. The target patient population consists of adolescents with inflammatory bowel diseases (IBD), aged between 16.75 and 17 years. The sample size calculation suggests that 160 subjects (80/ each arm) is required. The allocation ratio is 1:1. Eligible participants in the intervention arm attend a total of four joint transition visits with the adult and the pediatric gastroenterologist. In the control arm, adolescents meet only the pediatric gastroenterologist, but there is a balanced consultation between the two gastroenterologists regarding the patient's treatment plan. Patients in both groups receive the same training and education, the only determinative difference between the two arms is the presence of the adult gastroenterologist at the joint transition visits.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Joint visits<br>Subjects in the intervention arm attend a total of four joint transition visits performed with the participation of both the adult and the pediatric gastroenterologist. | Other: joint visits<br>* The intervention is the implementation of joint transition visits with the participation of both the pediatric and the adult gastroenterologist. One-year intervention period was chosen. In total, there are four joint visits every third months for the adolescents aged 17-18. Each joint visit lasts for at least for 20 minutes, although in case of complex medical history, there is no restriction with respect to the length of the visit. Joint transition visits 1, 2 and 3 (V1-3) are led by the pediatric gastroenterologist, and visit 4 (V4) is led by the adult gastroenterologist.<br>|
| No Intervention: Usual care<br>Adolescents meet only the pediatric gastroenterologist, but there is a balanced consultation between the two gastroenterologists with respect the patient's treatment plan. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient reported health-related quality of life (HRQoL) one year after transfer | HRQoL is measured with a validated and IBD-specific questionnaire, called IMPACT III (HR) (unabbreviated scale title is not existing). It consists of 35-items, using a five-point Likert self-completed response scale. The questions are related to the severity and frequency of the following symptoms over the last two weeks: bowel symptoms, systemic symptoms, emotional functioning, social functioning, body image and treatments or interventions. The lowest score is 35, that can be achieved, and the maximum is 175 points. Higher scores indicate better HRQoL. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of patients not lost to follow-up | Patients are considered as not lost to follow-up if they attend at least three out of the five planned visits with the adult gastroenterologist (AGE) during the follow-up period. Previously cancelled and then rescheduled AGE visits are acceptable. | 24 months | 
| Medication adherence | Measured with the Medical Adherence Report Scale (MARS-5) which consist of five statements with respect to the patient's medical adherence in the last one week. Patients can describe their behavior on a five-point Likert response scale ranging from 'always' to 'never' (1-5 points). The lowest total score that can be achieved is 5 (lowest adherence), while the highest is 25 (maximal adherence). Higher scores indicate better medical adherence. | 24 months | 
| Self-efficacy: IBDSES-A | Measured with IBD Self-Efficacy Scale for adolescents and young adults (IBDSES-A) questionnaire, which investigates the person's confidence in their ability to manage demands and is predictive of health outcomes in chronic disease. The maximum scores range from 21 to 57 (as reverse scoring is used in case of 2 items). Higher scores indicate higher self-efficacy. | 24 months | 
| Patient's satisfaction: CACHE | Measured with CACHE questionnaire (unabbreviated scale title is not existing), which consists of 31 questions with respect to the attitude of the medical team, the location, accessibility, and facilities of the IBD centre. Questions can be answered with a five-point Likert response scale. The final score can be given on a scale that ranges from 0 (minimum satisfaction) to 100 (maximum satisfaction). The final total score is calculated with standardization, using the following formula to determine the points of each individual item: (real score-minimum score)/ (maximum score-minimum score) ×100. Higher score indicates higher level of satisfaction. | 24 months | 
| Transition readiness (1) | Transition readiness is measured with the validated tool of Transition Readiness Questionnaire (STARx). STARx consists of three modules (with a total of 18 items), aiming to investigate the sense of responsibility, the disease-specific knowledge and the independency of the patients. Each item can be answered using a five-point Likert response scale and can be scored between 1 and 5 points. The maximum score is 90, higher score indicates better transition readiness. STARx is filled out by the participating adolescents and by their legal guardian too. | 24 months | 
| Transition readiness (2) | Transition readiness is measured with the validated tool of Transition Readiness Assessment Questionnaire (TRAQ). TRAQ consisting of 20 items and assesses the adolescents' willingness to be involved in or to be completely independent in managing disease related tasks (e.g., taking medications, making appointments, getting medications prescribed). A five-point Likert response scale (with scores range from 1 to 5) is used for answering each question. A total of 100 point can be acquired. In case of both tool, higher total scores indicate a higher level of transition readiness. | 24 months | 
| The number of flare-ups | Flare-ups are defined as clinical symptoms suggesting disease activity, accompanied with biochemical (e.g., stool calprotectin, c-reactive protein (CRP)), endoscopic, or imaging evidence of inflammation. Intensifying disease symptoms resulting in dose escalation or initiation of a new drug aiming to achieve remission are also considered as flare-ups. | 24 months | 
| The number of patients who needed the initiation of corticosteroid treatment | The number of patients who needed the initiation of corticosteroid treatment including the initiation of topical and systemic steroid formulations | 24 months | 
| The number of patients who needed the initiation of biological treatment | The number of patients who needed the initiation of biological treatment including the initiation of all types of biologics registered for the treatment of IBD | 24 months | 
| Stool calprotectin level | Measured in unit: mg/g | 24 months | 
| Disease activity (1) | In case of Crohn's disease, Pediatric Crohn's Disease Activity Index (PCDAI) is being used for the assessment of disease activity. PCDAI counts with clinical symptoms (e. g. abdominal pain, stool frequency) and laboratory parameters (e.g.: haematocrit, erythrocyte sedimentation rate, serum albumin level). The minimum of 0 point can be achieved, while the maximum is 110 points. Higher score indicates higher disease activity. (<10 points: Remission; 11-30 points: Moderate disease activity; >31 points: Severe disease activity) | 24 months | 
| Disease activity (2) | In case of Ulcerative Colitis, Pediatric Ulcerative Colitis Activity Index (PUCAI) is being used for the assessment of disease activity. PUCAI counts with clinical symptoms (e.g. abdominal pain, rectal bleeding, and activity level). The minimum of 0 point can be achieved, while the maximum is 85 points. Higher score indicates higher disease activity. (<10 points: Remission; 11-30 points: Moderate disease activity; >31 points: Severe disease activity) | 24 months | 
| Disease activity (3) | In case of luminal Crohn's disease, Crohn's Disease Activity Index (CDAI) is being used for the assessment of disease activity. CDAI is the sum of eight components (clinical symptoms (e.g. abdominal pain, number of liquid stools), finding of the physical examination (e.g. abdominal mass, body weight), laboratory parameters (e.g. Haematocrit)) to each of which is assigned a specific weight. The minimum of 0 point can be achieved, while the maximum is 600 points. Higher score indicates higher disease activity. (<150 points: Inactive disease; 151-220 points: Mild disease activity; 221-300: Moderate disease activity; 301-450: Severe disease activity; >450: Fulminant disease activity) | 24 months | 
| Disease activity (4) | In case of perianal Crohn's disease perianal Crohn's Disease Activity Index (pCDAI) is being used for the assessment of disease activity. pCDAI counts with the discharge, the pain/ restrictions of activities, the restrictions of sexual activities, and with the type of perianal disease. The minimum of 0 point can be achieved, while the maximum is 20 points. Higher score indicates higher perianal disease activity. | 24 months | 
| Disease activity (5) | In case of Ulcerative Colitis Mayo score is being used for the assessment of disease activity. Mayo score clinical symptoms (e.g. abdominal pain, rectal bleeding), findings of the endoscopy, and the physician's global assessment). The minimum of 0 point can be achieved, while the maximum is 12 points. Higher score indicates higher disease activity. (0-3 points: inactive disease, 4-6 points: mild disease activity, 7-9 points: moderate disease activity, >9 points: severe disease activity) | 24 months | 
| Laboratory parameter refers to inflammation: C-reactive protein (CRP) | C-reactive protein (CRP) is measured in unit: mg/l. Higher value of CRP indicates greater inflammation. | 24 months | 
| Laboratory parameter refers to inflammation: White blood cell count (WBC) | White blood cell count (WBC) is measured in unit: G/L. Higher value of WBC indicates greater inflammation. | 24 months | 
| Laboratory parameter refers to inflammation: Erythrocyte sedimentation rate (ESR) | Erythrocyte sedimentation rate (ESR) is measured in unit: mm/hour. Higher value of ESR indicates greater inflammation. | 24 months | 
| The number of unplanned visits at the caregiver gastroenterologist | Medical visits, which were not arranged in advance with the caring gastroenterologist, are considered unplanned visits | 24 months | 
| The number of visits at the emergency department | The number of visits at the emergency department, which are needed due to acute severe symptoms of IBD | 24 months | 
| The number of scheduled imaging performed | The number of images including abdominal ultrasound, x-ray, MRI, CT-scan and other images, which were arranged in advance | 24 months | 
| The number of urgent imaging performed | The number of images including abdominal ultrasound, x-ray, MRI, CT-scan and other images, which were not arranged in advance | 24 months | 
| The number of scheduled endoscopies performed | The number of endoscopies including gastroduodenoscopy and colonoscopy, which were arranged in advance | 24 months | 
| The number of urgent endoscopies performed | The number of endoscopies including gastroduodenoscopy and colonoscopy, which were not arranged in advance | 24 months | 
| The number of IBD-related surgical interventions performed | The number of surgical interventions, which were performed because of IBD | 24 months | 
| The number of IBD related hospital admissions | The number of hospital admissions, which were needed because of IBD | 24 months | 
| The length of IBD-related hospitalization | The length of the IBD-related hospitalization given in days. | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inflammatory bowel disease, transitional care, adolescents, chronic illness, quality of life, randomized controlled trial