Quality of Life Clinical Trial
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.
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.
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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