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Virtual Dietetic Interventions in Patients With Coeliac

NHS Foundation Trust logo

NHS Foundation Trust

Status

Not yet enrolling

Conditions

Coeliac Disease

Treatments

Other: Virtual Dietetic First-Appointment Webinar for Coeliac Disease
Other: Standard Dietetic Consultation (Face-to-Face or Telephone)

Study type

Interventional

Funder types

Other

Identifiers

NCT07172555
STH22680

Details and patient eligibility

About

This clinical study is exploring whether a pre-recorded, on-demand webinar led by specialist dietitians can be as effective as traditional one-on-one appointments in helping people newly diagnosed with coeliac disease learn to follow a gluten-free diet. Coeliac disease is a serious, life-long condition where eating even tiny amounts of gluten, a substance found in wheat, barley, and rye, can cause damaging symptoms and long-term health problems. The only current treatment is sticking to a strict gluten-free diet, which can be difficult without proper support and guidance from dietitians.

The number of people being diagnosed with coeliac disease in the UK is growing, and this is placing extra pressure on NHS dietetic services, which are already stretched. Many patients currently face long waits or do not get any dietetic support at all. To address this, the research team at Sheffield Teaching Hospitals has developed an on-demand, first-appointment webinar to provide immediate access to trusted dietary information, with the aim of improving patient care and saving NHS resources.

In this study, adults newly diagnosed with coeliac disease at Sheffield Teaching Hospitals will be asked to join one of two groups: one group will receive their first dietitian appointment through the new on-demand webinar, while the other group will have a traditional face-to-face or phone appointment with a dietitian. Both groups will complete short questionnaires to measure their knowledge about the gluten-free diet, their symptoms, how well they are following the diet, and their quality of life, both before and after receiving their dietary support, and again after six months. Blood tests will also be used to monitor health markers.

The main goal of the research is to find out if the first-appointment webinar is just as effective as traditional appointments in helping patients understand and follow a gluten-free diet, feel satisfied with the support they receive, and achieve good health outcomes. If the study shows that the webinar approach is as good as traditional care, it could mean quicker, easier, and more consistent access to essential dietary support for people with coeliac disease, both locally and across the UK.

Hypothesis:

The study hypothesis is that a dietitian-led, on-demand, pre-recorded webinar for a first appointment is as effective as traditional one-to-one consultations (face-to-face or by phone) in helping newly diagnosed coeliac patients achieve the same standard health outcomes, dietary knowledge, and satisfaction with care.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients aged 18 years and over with serology- or biopsy-proven coeliac disease.

Exclusion criteria

Patients under the age of 18 years. Patients unable to provide written informed consent. Patients who are unable to understand or speak English. Patients unable to access digital resources. Poly-diagnosis that requires additional nutritional intervention (i.e. Diabetes or Inflammatory Bowel Disease).

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Virtual Dietetic First-Appointment Webinar for Coeliac Disease
Experimental group
Description:
Participants allocated to this arm will receive a pre-recorded, dietitian-led "first appointment" webinar designed specifically for adults newly diagnosed with coeliac disease. The webinar will provide comprehensive education on the gluten-free diet, approaches to avoid cross-contamination, and strategies for nutritional adequacy. The intervention allows participants to watch and re-watch the webinar at their convenience. All participants will undergo baseline assessments and will complete knowledge and satisfaction questionnaires immediately post-intervention, with follow-up clinical and patient-reported outcomes collected at 6 months.
Treatment:
Other: Virtual Dietetic First-Appointment Webinar for Coeliac Disease
Standard Dietetic Consultation (Face-to-Face or Telephone)
Active Comparator group
Description:
Participants in this group are allocated to receive the existing standard of care: an individual appointment with a specialist dietitian, delivered either in person (face-to-face) or by telephone. During the appointment, the dietitian provides a comprehensive overview of the gluten-free diet, strategies for avoiding cross-contamination, and advice on nutritional adequacy. As in the experimental arm, baseline assessment and validated questionnaires are administered pre- and post-intervention, with follow-up at 6 months to collect clinical, adherence, satisfaction, and quality of life data for direct comparison with the on-demand webinar intervention.
Treatment:
Other: Standard Dietetic Consultation (Face-to-Face or Telephone)

Trial documents
2

Trial contacts and locations

1

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Central trial contact

David S Sanders, MBChB, MD, FRCP, FACG; Nick Trott, BSc, MSc

Data sourced from clinicaltrials.gov

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