Celiac Disease School for Women Living on a Gluten-free Diet

Study Overview
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Brief Summary
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Swedish celiac disease women living on a gluten-free diet for years report poorer subjective health and more bowel complaints than Swedish women of same age in general population. The investigators hypothesis is that the women participating in an education programme based on problem based learning will show higher degree of perceived health than the women receiving usual care.

Detailed Description
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Celiac disease is a disorder of the small intestines triggered by dietary gluten, a protein in wheat-containing foods. Living with is far from easy and associated with restrictions and various dilemmas in daily life, leading to depressed mood and reduced well-being, particularly in women. We decided to include 100 celiac disease women on a gluten-free diet into a randomized controlled education trial in order to compare problem-based learning with usual care. Outcome measures will be two frequently employed questionnaires: PGWB (Psychological Well-being Index) to monitor Well-being and GSRS (Gastrointestinal Symptom Rating Scale) to measure the rate bowel symptoms as assessed at 6 months after the intervention.

Official Title
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Structured Education of Swedish Celiac Women Living on a Gluten-free Diet for Years

Conditions
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Education of Patients, Counseling, Problem-Based Learning

Intervention / Treatment
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* Behavioral: Celiac school
* Behavioral: Usual care of celiac disease women


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 20 yrs or above with Celiac disease treated for at least five years Exclusion Criteria: Anticipated inability to comply the trial protocol

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care of celiac disease women<br>Written information corresponding to that offered when seeking medical advice for celiac disease in primary care | Behavioral: Usual care of celiac disease women<br>* Written information corresponding to that offered when seeking medical advice for well treated celiac disease in the primary care.<br>* Other names: Coeliac disease guidelines;|
| Experimental: Celiac School<br>Structured education using problem-based learning at 10 sessions | Behavioral: Celiac school<br>* Structured education of adult celiac patients at 10 sessions.<br>* Other names: Counselling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective health and well-being | Gastrointestinal symptoms and Psychological well-being | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal symptoms and Psychological well-being | Two questionnaires: Psychological General Well-Being Index and the Gastrointestinal Symptom Rating Scale. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Celiac disease, Education, Sweden, Gluten-free diet