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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884686
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Collaborator:
King's College London
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Quality of Life Inflammatory Bowel Diseases Other: Web-based education resource Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: One group will receive intervention and other group will receive usual care.
Masking: None (Open Label)
Primary Purpose: Other
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.
Actual Study Start Date : December 16, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
Experimental: Web-based intervention
Patients allocated to intervention arm will have unlimited free access to a web-based education resource.
Other: Web-based education resource
Intervention includes fact sheets, question and answers, short videos featuring patients and/or clinicians.

No Intervention: Usual care
Patients allocated to usual care will receive all usual care and education opportunities.



Primary Outcome Measures :
  1. Change in food-related quality of life score as measured using validated questionnaire FR-QoL-29 [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. Change in United Kingdom inflammatory bowel disease questionnaire score [ Time Frame: 3 months ]
    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.

  2. Change in disease activity index as measured using validated questionnaires [ Time Frame: 3 months ]
    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. Change in presence of anxiety and depression score [ Time Frame: 3 months ]
    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.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884686


Contacts
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Contact: Kevin Whelan +442078483858 kevin.whelan@kcl.ac.uk
Contact: Reza Razavi +442078486390 reza.razavi@kcl.ac.uk

Locations
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United Kingdom
Guy's and St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom, SE1 9RT
Contact: Jennifer Boston       R&D@gstt.nhs.uk   
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
King's College London
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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03884686    
Other Study ID Numbers: IRAS 241127
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis