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临床试验/NCT07172555
NCT07172555招募中不适用

The Role Of Virtual Dietetic Interventions In Patients With Coeliac Disease

Sheffield Teaching Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Change in Knowledge of Gluten-Free Diet

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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).

研究组 & 干预措施

Virtual Dietetic First-Appointment Webinar for Coeliac Disease

Experimental

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.

干预措施: Virtual Dietetic First-Appointment Webinar for Coeliac Disease (Other)

Standard Dietetic Consultation (Face-to-Face or Telephone)

Active Comparator

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.

干预措施: Standard Dietetic Consultation (Face-to-Face or Telephone) (Other)

结局指标

主要结局

Change in Knowledge of Gluten-Free Diet

时间窗: Baseline (pre-intervention), immediately post-intervention, and at 6-month follow-up.

Assessed using the Coeliac Disease and Gluten-Free Diet Quiz, a structured and previously validated questionnaire administered at baseline, immediately post-intervention, and at 6 months. This tool evaluates patient knowledge related to coeliac disease and the gluten-free diet requirements for effective disease management. Scores pre- and post-intervention (webinar or standard care) will be compared to determine the educational impact of each modality.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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