Celiac Disease School for Women Living on a Gluten-free Diet
CDST
Structured Education of Swedish Celiac Women Living on a Gluten-free Diet for Years
2 other identifiers
interventional
106
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 16, 2010
CompletedFirst Posted
Study publicly available on registry
March 17, 2010
CompletedMarch 17, 2010
January 1, 2001
5 months
March 16, 2010
March 16, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Subjective health and well-being
Gastrointestinal symptoms and Psychological well-being
6 months
Secondary Outcomes (1)
Gastrointestinal symptoms and Psychological well-being
6 months
Study Arms (2)
Usual care of celiac disease women
ACTIVE COMPARATORWritten information corresponding to that offered when seeking medical advice for celiac disease in primary care
Celiac School
EXPERIMENTALStructured education using problem-based learning at 10 sessions
Interventions
Structured education of adult celiac patients at 10 sessions.
Written information corresponding to that offered when seeking medical advice for well treated celiac disease in the primary care.
Eligibility Criteria
You may qualify if:
- Women aged 20 yrs or above with Celiac disease treated for at least five years
You may not qualify if:
- Anticipated inability to comply the trial protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Norrkoping Hospital,
Norrköping, S-601 82, Sweden
Related 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. doi: 10.1046/j.1471-6712.2003.00228.x.
PMID: 12919466BACKGROUNDSverker A, Hensing G, Hallert C. 'Controlled by food'- lived experiences of coeliac disease. J Hum Nutr Diet. 2005 Jun;18(3):171-80. doi: 10.1111/j.1365-277X.2005.00591.x.
PMID: 15882379BACKGROUNDMidhagen 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. doi: 10.1111/j.1572-0241.2003.07632.x.
PMID: 14499782BACKGROUNDRoos S, Karner A, Hallert C. Psychological well-being of adult coeliac patients treated for 10 years. Dig Liver Dis. 2006 Mar;38(3):177-80. doi: 10.1016/j.dld.2006.01.004. Epub 2006 Feb 7.
PMID: 16461026BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Claes Hallert, MD, PhD
Norrkoping Hospitalö
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
March 16, 2010
First Posted
March 17, 2010
Study Start
August 1, 2008
Primary Completion
January 1, 2009
Study Completion
March 1, 2010
Last Updated
March 17, 2010
Record last verified: 2001-01