Telephone Consultation as a Substitute for Routine Out-patient Face-to-face Consultation for Children With Inflammatory Bowel Disease

NCT02319798 | Completed

• 1 other identifier: IBDV227APR2010
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Inflammatory bowel disease (IBD) refers to two chronic diseases (Crohn's disease and ulcerative colitis) that affect the intestines. The number of new cases of IBD in people younger than 16 years old has been increasing in the United Kingdom (UK), and is currently estimated to be 700 new cases every year. There is no cure for IBD and patients experience episodes of flareups in between periods of wellbeing. Traditionally, children with IBD are asked to attend regular hospital appointments. This means that, even if they are well, they have to get to the hospital and this can involve travelling long distances. Telephone consultations have been shown to be beneficial in some areas of medicine but this approach has not been well studied in children. The aims of this study are to determine whether telephone consultations would improve quality of life, patient satisfaction, proportion of consultations attended and whether they would be safe and reduce costs for patients and the National Health Service (NHS). Investigators plan a randomised controlled trial involving 92 participants recruited from amongst the 250 children and adolescents aged between 8 and 16 years who attend the regional paediatric IBD centre in Manchester. Half will be assigned to telephone consultations, and half to face to face consultations. The study would have the approval of the local ethics committee and participants would have provided written consent. Investigators will compare outcomes in the two groups over 2 years. If telephone consultations prove to be effective, the NHS could offer children with IBD the choice of either telephone consultation or face to face consultation for their outpatient followup. Those who are doing well would not have to make unnecessary journeys to the hospital. This would free up clinic spaces and allow patients who are unwell, and new patients to be seen more quickly, thus reducing waiting

Conditions

Crohn's Disease; Ulcerative Colitis

Keywords

Crohn's disease; ulcerative colitis; Inflammatory bowel disease; IBD

Outcome Measures

Primary Outcomes (1)

• Changes in the paediatric IBD-specific health-related quality of life (QOL) scores.

  QOL scores will be assessed at baseline, and 6-monthly over the 2-year follow-up period using the validated paediatric IBD QOL IMPACT questionnaire

  6 monthly over 2 years

Secondary Outcomes (1)

• Relapses

  All relapses over 2 years

Other Outcomes (1)

• Patient satisfaction with consultations

  every appointment during study period ( over 2 years)

Study Arms (2)

face-to-face consultations

ACTIVE COMPARATOR

Those randomized to face-to-face follow up will attend their appointments in hospital as usual.

Other: face-to-face consultations

telephone consultations

EXPERIMENTAL

Those randomized to telephone consultation will be told to expect a call from the gastroenterology doctor at the time of their appointment.

Other: telephone consultations

Interventions

telephone consultations OTHER

Those randomized to telephone consultation will be told to expect a call from the gastroenterology doctor at the time of their appointment.

telephone consultations

face-to-face consultations OTHER

Those randomized to face-to-face follow up will attend their appointments in hospital

face-to-face consultations

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• patients aged between 8 and 16 years
• diagnosis of IBD by established clinical, endoscopic, histological and radiological criteria
• clinical remission defined as an abbreviated Paediatric Crohn's Disease Activity Index (aPCDAI) score of ≤10 for patients with Crohn's disease or as a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of \<10 for those with ulcerative colitis and indeterminate colitis
• parental and child's consent to participate in the study.

You may not qualify if:

• active disease (aPCDAI\>15 or PUCAI ≥15)
• unwillingness to provide informed consent.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Royal Manchester Children's Hospital

Manchester, Lancs, M13 9WL, United Kingdom

Location

Related Publications (1)

• Akobeng AK, O'Leary N, Vail A, Brown N, Widiatmoko D, Fagbemi A, Thomas AG. Telephone Consultation as a Substitute for Routine Out-patient Face-to-face Consultation for Children With Inflammatory Bowel Disease: Randomised Controlled Trial and Economic Evaluation. EBioMedicine. 2015 Aug 8;2(9):1251-6. doi: 10.1016/j.ebiom.2015.08.011. eCollection 2015 Sep.

  PMID: 26501125 DERIVED

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: December 18, 2014
• Study Start: July 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: January 1, 2014
• Last Updated: December 4, 2018

Record last verified: 2018-11

Locations

GB (1)