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

NCT ID: NCT04290156

Last Updated: 2020-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2024-11-01

Brief Summary

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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

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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.

Conditions

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Inflammatory Bowel Diseases Crohn's Disease Ulcerative Colitis

Keywords

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inflammatory bowel disease transitional care adolescents chronic illness quality of life randomized controlled trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Due to the nature of the study, the blinding of the participants and personnel (pediatric and adult gastroenterologists, medical staff) is not possible, however, the blinding of the data managers and statisticians will be secured.

Study Groups

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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.

Group Type EXPERIMENTAL

joint visits

Intervention Type OTHER

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

16 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pecs

OTHER

Sponsor Role lead

Responsible Party

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Sarlós Patrícia

Divison of Gastroenterology, First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Péter Hegyi, MD, PhD, DSc

Role: STUDY_CHAIR

Insitute for Translational Medicine, University of Pécs, HU

Patrícia Sarlós, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

First Department of Medicine, University of Pécs, Medical School, Pécs, Hungary

Central Contacts

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Adrienn Erős, MD

Role: CONTACT

Phone: +36703794131

Email: [email protected]

Patrícia Sarlós, MD, PhD

Role: CONTACT

Phone: +3672536000

Email: [email protected]

References

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Brooks AJ, Smith PJ, Cohen R, Collins P, Douds A, Forbes V, Gaya DR, Johnston BT, McKiernan PJ, Murray CD, Sebastian S, Smith M, Whitley L, Williams L, Russell RK, McCartney SA, Lindsay JO. UK guideline on transition of adolescent and young persons with chronic digestive diseases from paediatric to adult care. Gut. 2017 Jun;66(6):988-1000. doi: 10.1136/gutjnl-2016-313000. Epub 2017 Feb 21.

Reference Type BACKGROUND
PMID: 28228488 (View on PubMed)

van Rheenen PF, Aloi M, Biron IA, Carlsen K, Cooney R, Cucchiara S, Cullen G, Escher JC, Kierkus J, Lindsay JO, Roma E, Russell RK, Sieczkowska-Golub J, Harbord M. European Crohn's and Colitis Organisation Topical Review on Transitional Care in Inflammatory Bowel Disease. J Crohns Colitis. 2017 Sep 1;11(9):1032-1038. doi: 10.1093/ecco-jcc/jjx010.

Reference Type BACKGROUND
PMID: 28158494 (View on PubMed)

Suris JC, Akre C. Key elements for, and indicators of, a successful transition: an international Delphi study. J Adolesc Health. 2015 Jun;56(6):612-8. doi: 10.1016/j.jadohealth.2015.02.007.

Reference Type BACKGROUND
PMID: 26003575 (View on PubMed)

Fair C, Cuttance J, Sharma N, Maslow G, Wiener L, Betz C, Porter J, McLaughlin S, Gilleland-Marchak J, Renwick A, Naranjo D, Jan S, Javalkar K, Ferris M; International and Interdisciplinary Health Care Transition Research Consortium. International and Interdisciplinary Identification of Health Care Transition Outcomes. JAMA Pediatr. 2016 Mar;170(3):205-11. doi: 10.1001/jamapediatrics.2015.3168.

Reference Type BACKGROUND
PMID: 26619178 (View on PubMed)

van den Brink G, van Gaalen MAC, de Ridder L, van der Woude CJ, Escher JC. Health Care Transition Outcomes in Inflammatory Bowel Disease: A Multinational Delphi Study. J Crohns Colitis. 2019 Sep 19;13(9):1163-1172. doi: 10.1093/ecco-jcc/jjz044.

Reference Type BACKGROUND
PMID: 30766997 (View on PubMed)

Eros A, Soos A, Hegyi P, Szakacs Z, Eross B, Parniczky A, Mezosi E, Rumbus Z, Sarlos P. Spotlight on Transition in Patients With Inflammatory Bowel Disease: A Systematic Review. Inflamm Bowel Dis. 2020 Feb 11;26(3):331-346. doi: 10.1093/ibd/izz173.

Reference Type BACKGROUND
PMID: 31504524 (View on PubMed)

Eros A, Dohos D, Veres G, Tarnok A, Vincze A, Teszas A, Zadori N, Gede N, Hegyi P, Sarlos P. Effect of joint transition visits on quality of life in adolescents with inflammatory bowel diseases: a protocol for a prospective, randomised, multicentre, controlled trial (TRANS-IBD). BMJ Open. 2020 Oct 6;10(10):e038410. doi: 10.1136/bmjopen-2020-038410.

Reference Type DERIVED
PMID: 33028560 (View on PubMed)

Other Identifiers

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50457-2/2019/EKU

Identifier Type: -

Identifier Source: org_study_id