Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: 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.
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


Options:
A: Arm Label: face-to-face consultations; Type: ACTIVE_COMPARATOR; Interventions: Other: face-to-face consultations | Arm Label: telephone consultations; Type: EXPERIMENTAL; Interventions: Other: telephone consultations | Intervention Type: OTHER; Name: telephone consultations; Assigned to Arm(s): telephone consultations | Intervention Type: OTHER; Name: face-to-face consultations; Assigned to Arm(s): face-to-face consultations
B: Arm Label: Telemedicine group; Type: EXPERIMENTAL; Interventions: Device: Telemedicine | Arm Label: Telephone support group; Type: EXPERIMENTAL; Interventions: Device: Telephone | Arm Label: Control group; Type: ACTIVE_COMPARATOR; Interventions: Other: Conventional care | Intervention Type: DEVICE; Name: Telemedicine; Assigned to Arm(s): Telemedicine group | Intervention Type: DEVICE; Name: Telephone; Assigned to Arm(s): Telephone support group | Intervention Type: OTHER; Name: Conventional care; Assigned to Arm(s): Control group
C: Arm Label: Wait List; Type: OTHER; Interventions: Behavioral: Wait list comparison group | Arm Label: 2 phone sessions; Type: EXPERIMENTAL; Interventions: Behavioral: 2 Family-based problem solving phone sessions | Arm Label: 4 phone sessions; Type: EXPERIMENTAL; Interventions: Behavioral: 4 Family-based problem solving phone intervention sessions | Intervention Type: BEHAVIORAL; Name: 2 Family-based problem solving phone sessions; Assigned to Arm(s): 2 phone sessions | Intervention Type: BEHAVIORAL; Name: 4 Family-based problem solving phone intervention sessions; Assigned to Arm(s): 4 phone sessions | Intervention Type: BEHAVIORAL; Name: Wait list comparison group; Assigned to Arm(s): Wait List
D: Arm Label: HealthPROMISE users; Type: EXPERIMENTAL; Interventions: Other: HealthPROMISE users | Arm Label: Control Group; Type: PLACEBO_COMPARATOR; Interventions: Other: Control Group | Intervention Type: OTHER; Name: HealthPROMISE users; Assigned to Arm(s): HealthPROMISE users | Intervention Type: OTHER; Name: Control Group; Assigned to Arm(s): Control Group

Answer: A