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

NCT04290156 | Unknown DMC

• 1 other identifier: 50457-2/2019/EKU
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Inflammatory Bowel Diseases; Crohn's Disease; Ulcerative Colitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (27)

• The number of patients not lost to follow-up

  24 months

• Medication adherence

  24 months

• Self-efficacy: IBDSES-A

  24 months

• Patient's satisfaction: CACHE

  24 months

• Transition readiness (1)

  24 months

Study Arms (2)

Joint visits

EXPERIMENTAL

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

Usual care

NO INTERVENTION

Adolescents meet only the pediatric gastroenterologist, but there is a balanced consultation between the two gastroenterologists with respect the patient's treatment plan.

Interventions

joint visits 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.

Joint visits

Eligibility Criteria

• Age: 16 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pecs: lead

Related Publications (7)

• 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.

  PMID: 28228488 BACKGROUND

• 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.

  PMID: 28158494 BACKGROUND

• 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.

  PMID: 26003575 BACKGROUND

• 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.

  PMID: 26619178 BACKGROUND

• 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.

  PMID: 30766997 BACKGROUND

• 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.

  PMID: 31504524 BACKGROUND

• 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.

  PMID: 33028560 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Chronic Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Péter Hegyi, MD, PhD, DSc

  Insitute for Translational Medicine, University of Pécs, HU

  STUDY CHAIR

• Patrícia Sarlós, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrienn Erős, MD

CONTACT

+36703794131; adriennhat@gmail.com

Patrícia Sarlós, MD, PhD

CONTACT

+3672536000; sarlos.patricia@pte.hu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Divison of Gastroenterology, First Department of Medicine, Medical School, University of Pécs, Pécs, Hungary

Model Details: 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.

Study Record Dates

• First Submitted: February 16, 2020
• First Posted: February 28, 2020
• Study Start: April 1, 2020
• Primary Completion: April 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 28, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share