Promote Food. Improving Food-related Quality of Life in Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
In previous studies, people with inflammatory bowel disease reported that the disease had a large impact on the psychosocial aspects of eating and drinking, and a high proportion of people felt excluded from social interactions that involved eating and drinking (for example religious, family) and there was considerable uncertainty around how eating will affect bowel function together with feelings of reduced autonomy and high levels of stress and anxiety. These patient experiences may lead to reduced food related quality of life. This randomised control trial will examine the feasibility of using a web based intervention to improve the food related quality of life of people with inflammatory bowel disease. Fifty eligible participants will be randomised to receive either a 3-month website based intervention or usual care. The feasibility of study design, an estimate of the efficacy of the website intervention and patient experience of the intervention will be assessed after three months. Patients will be recruited from inflammatory bowel disease outpatient clinics at Guy's and St Thomas' NHS Foundation Trust and Bart's Health NHS Trust in the United Kingdom.

Detailed Description
-----------------
The intervention. The web based intervention has been developed based on the outcomes of a previous study. The website is partially populated with several pages which contain educational material designed for patients newly diagnosed (within the last 12 months) with inflammatory bowel disease. The education material provides information related to different problems, short video clips of patients talking about their problems and ways of managing it, or a patient and health care professional consultation in relation to a particular problem, as well as question and answer fact sheets. In order to make the intervention relevant and acceptable to patients and health care professionals, both these groups were actively involved at each stage of the intervention development. During the 3 month intervention patients will have free and unlimited access to the website. Use of the website during the intervention phase will be monitored by the researcher and weekly emails will be sent to participants who do not engage in the intervention. Monthly emails will be sent to all intervention group patients to encourage engagement with the intervention. Usual care. The patients randomised to usual care will have access to all usual care, including scheduled appointments and nurse-led telephone helpful. They will not have access to the intervention website.

Official Title
-----------------
Promote Food. Improving Food-related Quality of Life in Patients With Inflammatory Bowel Disease: a Feasibility Study of a Web-base Educational Intervention.

Conditions
-----------------
Quality of Life, Inflammatory Bowel Diseases

Intervention / Treatment
-----------------
* Other: Web-based education resource


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People diagnosed with either Crohn's disease or ulcerative colitis (collectively called inflammatory bowel disease) within the last 12 months Proof of diagnosis (record of diagnostic endoscopy) Aged 16 years and over People who are experiencing food-related problems as a result of their inflammatory bowel disease (90 points or below, out of possible 145 measured by food related quality of life questionnaire) People consuming a free oral diet Sufficient command of written and spoken English to understand the study documentation and procedures Access to internet and skills and ability to use electronic resources Exclusion Criteria: People diagnosed with inflammatory bowel disease for more than 12 months Diagnosis of indeterminate colitis Hospitalised, nursing home or any other form of institutionalised living Receiving intravenous nutrition, enteral nutrition or oral nutritional support which means that food intake is less than 50% of energy requirements (i.e. their energy from food is less than their energy intake from artificial nutritional support) Diagnoses of other co-morbidities that may have impact on diet e.g. diabetes mellitus, coeliac disease, food allergies (not related to inflammatory bowel disease) Pregnancy or less than 6 months post-partum Inability to give informed consent (due to reduced mental capacity)

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One group will receive intervention and other group will receive usual care.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web-based intervention<br>Patients allocated to intervention arm will have unlimited free access to a web-based education resource. | Other: Web-based education resource<br>* Intervention includes fact sheets, question and answers, short videos featuring patients and/or clinicians.<br>|
| No Intervention: Usual care<br>Patients allocated to usual care will receive all usual care and education opportunities. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in food-related quality of life score as measured using validated questionnaire FR-QoL-29 | Measured using validated questionnaire Food-Related Quality of Life (FR-QOL), consisting of 29 questions. Each question is answered on a 5 point Likert scale. The sum of which is the overall score. The minimum score is 29 (low food related quality of life) and maximum 145 (high food related quality of life). A score of less than 90 suggests poor food related quality of life. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in United Kingdom inflammatory bowel disease questionnaire score | Measured using validated questionnaire the United Kingdom inflammatory bowel disease questionnaire (UK-IBDQ). This is a global disease specific quality of life questionnaire composed of 32 questions which are scored on a 4 point scale. Minimum score is 32 which indicates very poor quality of life and maximum score is 128 which is optimal quality of life. | 3 months | 
| Change in disease activity index as measured using validated questionnaires | Measured using validated disease specific questionnaires Harvey Bradshaw Index (HBI) if patient has Crohn's disease. This questionnaire contains five questions. If the patient has ulcerative colitis the simple clinical colitis activity index (SCCAI) questionnaire will be used. It contains six questions. The minimum scores for both questionnaires is 0 and indicates disease is in remission. There are no maximum values but the higher the number the greater severe the disease activity. | 3 months | 
| Change in presence of anxiety and depression score | Measured using validated questionnaire the hospital anxiety and depression score (HADS). The questionnaire contains 14 questions which are scored from 0 to 4. Seven questions relate to anxiety and seven relate to depression. An anxiety or depression sub-score of 0 suggests absence of anxiety or depression and a sub-score of eight or greater suggests borderline presence of anxiety or depression. A sub-score of 10 or more suggests presence of anxiety or depression. | 3 months |