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

2020. február 26. frissítette: 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.

A tanulmány áttekintése

Állapot

Még nincs toborzás

Körülmények

Beavatkozás / kezelés

Részletes leírás

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.

Tanulmány típusa

Beavatkozó

Beiratkozás (Várható)

160

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányozza a kapcsolattartók biztonsági mentését

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

16 év (Gyermek)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Leírás

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)

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Egészségügyi szolgáltatások kutatása
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Nincs (Open Label)

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: 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.
Egyéb: 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.
Nincs beavatkozás: 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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Change in patient reported health-related quality of life (HRQoL) one year after transfer
Időkeret: 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

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
The number of patients not lost to follow-up
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 24 months
Measured in unit: mg/g
24 months
Disease activity (1)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 24 months
The number of endoscopies including gastroduodenoscopy and colonoscopy, which were arranged in advance
24 months
The number of urgent endoscopies performed
Időkeret: 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
Időkeret: 24 months
The number of surgical interventions, which were performed because of IBD
24 months
The number of IBD related hospital admissions
Időkeret: 24 months
The number of hospital admissions, which were needed because of IBD
24 months
The length of IBD-related hospitalization
Időkeret: 24 months
The length of the IBD-related hospitalization given in days.
24 months

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

University of Pecs

Nyomozók

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

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Várható)

2020. április 1.

Elsődleges befejezés (Várható)

2024. április 1.

A tanulmány befejezése (Várható)

2024. november 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2020. február 16.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2020. február 26.

Első közzététel (Tényleges)

2020. február 28.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2020. február 28.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2020. február 26.

Utolsó ellenőrzés

2020. február 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • 50457-2/2019/EKU

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Nem

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

Klinikai vizsgálatok a Gyulladásos bélbetegségek

Klinikai vizsgálatok a joint visits

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Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

CROs by country

CROs in Burkina Faso

Körülmények

Ritka betegségek

Kábítószer-beavatkozások

Táplálék-kiegészítők

Szponzor / közreműködők

Helyek

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