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

Counseling Clinical Trial

— CDST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01088152
• Other study ID #: FORSS-80731
• Secondary ID: M218-08
• Status: Recruiting
• Phase: N/A
• First received: March 16, 2010
• Last updated: March 16, 2010
• Start date: August 2008
• Est. completion date: March 2010

Study information

• Verified date: January 2001
• Source: Medical Research Council of Southeast Sweden
• Contact: Lisa Jacobsson, MSc RN
• Phone: +4611363595
• Email: lisa.ring.jacobsson[@]isv.liu.se
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: March 2010
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Celiac Disease
• Counseling
• Education of Patients
• Problem-Based Learning

Intervention

Behavioral:
• Celiac school
Structured education of adult celiac patients at 10 sessions.
• Usual care of celiac disease women
Written information corresponding to that offered when seeking medical advice for well treated celiac disease in the primary care.

Locations

Country	Name	City	State
Sweden	Norrkoping Hospital,	Norrkoping

Sponsors (2)

Lead Sponsor	Collaborator
Medical Research Council of Southeast Sweden	Linkoeping University

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

Hallert C, Sandlund O, Broqvist M. Perceptions of health-related quality of life of men and women living with coeliac disease. Scand J Caring Sci. 2003 Sep;17(3):301-7. — View Citation

Midhagen G, Hallert C. High rate of gastrointestinal symptoms in celiac patients living on a gluten-free diet: controlled study. Am J Gastroenterol. 2003 Sep;98(9):2023-6. — View Citation

Roos S, Kärner A, Hallert C. Psychological well-being of adult coeliac patients treated for 10 years. Dig Liver Dis. 2006 Mar;38(3):177-80. Epub 2006 Feb 7. — View Citation

Sverker A, Hensing G, Hallert C. 'Controlled by food'- lived experiences of coeliac disease. J Hum Nutr Diet. 2005 Jun;18(3):171-80. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective health and well-being	Gastrointestinal symptoms and Psychological well-being	6 months	No
Secondary	Gastrointestinal symptoms and Psychological well-being	Two questionnaires: Psychological General Well-Being Index and the Gastrointestinal Symptom Rating Scale.	6 months	No