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

Medical Research Council of Southeast Sweden

Status: Unknown

Conditions: Problem-Based Learning; Counseling; Education of Patients

Treatments: Behavioral: Celiac school; Behavioral: Usual care of celiac disease women

Study type: Interventional

Funder types: Other

Identifiers

NCT01088152

M218-08 (Other Identifier)

FORSS-80731

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 106 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Usual care of celiac disease women

Active Comparator group

Description:

Written information corresponding to that offered when seeking medical advice for celiac disease in primary care

Treatment:

Behavioral: Usual care of celiac disease women

Celiac School

Experimental group

Description:

Structured education using problem-based learning at 10 sessions

Treatment:

Behavioral: Celiac school