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

2020년 2월 26일 업데이트: Sarlós Patrícia, University of Pecs

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)

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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (예상)

160

단계

  • 해당 없음

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연구 연락처

연구 연락처 백업

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

16년 (어린이)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Joint visits
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.
다른: joint visits
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.
간섭 없음: Usual care
Adolescents meet only the pediatric gastroenterologist, but there is a balanced consultation between the two gastroenterologists with respect the patient's treatment plan.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in patient reported health-related quality of life (HRQoL) one year after transfer
기간: 24 months
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

2차 결과 측정

결과 측정
측정값 설명
기간
The number of patients not lost to follow-up
기간: 24 months
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
기간: 24 months
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
기간: 24 months
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
기간: 24 months
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)
기간: 24 months
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)
기간: 24 months
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
기간: 24 months
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
기간: 24 months
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
기간: 24 months
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
기간: 24 months
Measured in unit: mg/g
24 months
Disease activity (1)
기간: 24 months

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)
기간: 24 months

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)
기간: 24 months

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)
기간: 24 months

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)
기간: 24 months

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)
기간: 24 months
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)
기간: 24 months
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)
기간: 24 months
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
기간: 24 months
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
기간: 24 months
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
기간: 24 months
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
기간: 24 months
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
기간: 24 months
The number of endoscopies including gastroduodenoscopy and colonoscopy, which were arranged in advance
24 months
The number of urgent endoscopies performed
기간: 24 months
The number of endoscopies including gastroduodenoscopy and colonoscopy, which were not arranged in advance
24 months
The number of IBD-related surgical interventions performed
기간: 24 months
The number of surgical interventions, which were performed because of IBD
24 months
The number of IBD related hospital admissions
기간: 24 months
The number of hospital admissions, which were needed because of IBD
24 months
The length of IBD-related hospitalization
기간: 24 months
The length of the IBD-related hospitalization given in days.
24 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Pecs

수사관

  • 수석 연구원: Patrícia Sarlós, MD, PhD, First Department of Medicine, University of Pécs, Medical School, Pécs, Hungary

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일반 간행물

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연구 시작 (예상)

2020년 4월 1일

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2024년 4월 1일

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2024년 11월 1일

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2020년 2월 28일

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  • 50457-2/2019/EKU

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