A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms

Официальное название

A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms: A Randomised, Controlled Intervention to Assess Efficacy and Cost-effectiveness

Обзор

This research project aims to test whether early interventions delivered remotely and prior to integrated care clinic appointments are effective. Patients with chronic unexplained gastrointestinal symptoms will initially undergo structured assessment of symptoms and wheat intolerance delivered remotely. Patients who continue to experience symptoms will then be randomised to a pre-consultation intervention ((a) standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing) followed by randomisation to the consultation intervention ((a) consultant-led outpatient clinic or b) a integrated care clinic depending on their response to the initial intervention.

Подробное описание

An Effectiveness-Implementation Hybrid Design with a two stage randomisation will be used to determine and compare efficacy and cost-effectiveness of different management approaches/interventions for patients with relevant, chronic, or relapsing gastrointestinal symptoms without concerning features and on the wait list for integrated care clinic at the Princess Alexandra Hospital. Approximately 200 patients will initially receive standardised assessment of symptoms and wheat intolerance. Those patients that continue to experience symptoms will then be randomised to a pre-consultation intervention (a) standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing) followed by randomisation to the consultation intervention (a) consultant-led outpatient clinic or b) an integrated care clinic conditional on their response to the initial intervention. Specific aims of the study include Aim 1: Determine efficacy (symptom improvement) and cost-effectiveness (quality adjusted life years) of a structured, digital technology enabled approach for the management of patients with severe functional gastrointestinal disorders as compared to established service models; Aim 2: Identify response-predictors for the pre-clinical dietary intervention, internet delivered cognitive behavior therapy, exercise physiology and the various clinical interventions; Aim 3: Define acceptance of consumers and staff for the new service model relative to established models of care and Aim 4. To determine the dietary patterns of people with functional gastrointestinal disorders who are presenting with symptoms necessary to access tertiary care and to further examine changes in diet after a range of interventions delivered by telehealth.

Вмешательства

• Поведенческое a)standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing
  Pre consultation interventions consist of one of four intervention a)standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing
• Поведенческое a) consultant-led outpatient clinic or b) a integrated care clinic
  Consultation intervention consists of one of two interventions a) consultant-led outpatient clinic or b) a integrated care clinic

Первичные конечные точки

• Structured Assessment of Gastrointestinal Symptoms score [Срок оценки: Week 0]
• Structured Assessment of Gastrointestinal Symptoms score [Срок оценки: Week 8]
• Structured Assessment of Gastrointestinal Symptoms score [Срок оценки: Week 16]
• Structured Assessment of Gastrointestinal Symptoms score [Срок оценки: Week 20]
• Structured Assessment of Gastrointestinal Symptoms score [Срок оценки: Week 24]
• Structured Assessment of Gastrointestinal Symptoms score [Срок оценки: Week 28]
• Structured Assessment of Gastrointestinal Symptoms score [Срок оценки: Week 32]
• Structured Assessment of Gastrointestinal Symptoms score [Срок оценки: Week 35]
• Structured Assessment of Gastrointestinal Symptoms score [Срок оценки: Week 38]
• Structured Assessment of Gastrointestinal Symptoms score [Срок оценки: Week 44]

Вторичные конечные точки (10)

• Hospital Anxiety and Depression Scale [Срок оценки: Week 0]
• Hospital Anxiety and Depression Scale [Срок оценки: Week 16]
• Hospital Anxiety and Depression Scale [Срок оценки: Week 28]
• Hospital Anxiety and Depression Scale [Срок оценки: Week 44]
• Microbiome [Срок оценки: Week 0]
• Microbiome [Срок оценки: Week 16]
• Microbiome [Срок оценки: Week 28]
• Microbiome [Срок оценки: Week 44]
• Acceptance of models of care by consumers and staff [Срок оценки: Week 16]
• Acceptance of models of care by consumers and staff [Срок оценки: Week 28]

Критерии участия

Критерии включения

• Patients with relevant, chronic, or relapsing gastrointestinal (GI) symptoms without concerning features and on the wait list for integrated care clinic (ICC) will be included in the study.
• Patients with severe symptoms as defined by a total Structured Assessment of Gastrointestinal Symptoms (SAGIS) score > 35
• Patients aged 18 years or older to 90 years old

Критерии исключения

• Patients with 'alarm' signs or symptoms (significant unexplained weight loss, evidence for gastrointestinal bleeding, iron deficiency anaemia, new onset GI symptoms) will be triaged to undergo urgent clinical work-up before they can be considered for inclusion into the study
• Patients with mild or moderate symptoms (e.g. not requiring clinical work-up or who will likely spontaneously improve) will not be eligible for inclusion into the study and will be managed as clinically indicated.
• Patients with any comorbidities that would interfere with the objectives of these interventions will be managed via the routine clinical pathways.
• Patients with a prior history of any eating disorder, wait listed for bariatric surgery or have had bariatric surgery will be excluded

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Австралия · 1 центр

• Princess Alexandra Hospital — Woolloongabba

Идентификаторы

NCT: NCT05274854 · APP2004495

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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