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

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ClinicalTrials.gov Identifier: NCT01088152
Recruitment Status : Unknown
Verified January 2001 by Medical Research Council of Southeast Sweden.
Recruitment status was:  Recruiting
First Posted : March 17, 2010
Last Update Posted : March 17, 2010
Sponsor:
Collaborator:
Linkoeping University
Information provided by:
Medical Research Council of Southeast Sweden

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.


Condition or disease Intervention/treatment
Education of Patients Counseling Problem-Based Learning Behavioral: Celiac school Behavioral: Usual care of celiac disease women

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Structured Education of Swedish Celiac Women Living on a Gluten-free Diet for Years
Study Start Date : August 2008
Primary Completion Date : January 2009
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Usual care of celiac disease women
Written information corresponding to that offered when seeking medical advice for celiac disease in primary care
Behavioral: 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.
Other Name: Coeliac disease guidelines
Experimental: Celiac School
Structured education using problem-based learning at 10 sessions
Behavioral: Celiac school
Structured education of adult celiac patients at 10 sessions.
Other Names:
  • Patient education
  • Counselling



Primary Outcome Measures :
  1. Subjective health and well-being [ Time Frame: 6 months ]
    Gastrointestinal symptoms and Psychological well-being


Secondary Outcome Measures :
  1. Gastrointestinal symptoms and Psychological well-being [ Time Frame: 6 months ]
    Two questionnaires: Psychological General Well-Being Index and the Gastrointestinal Symptom Rating Scale.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01088152


Contacts
Contact: Lisa Jacobsson, MSc RN +4611363595 lisa.ring.jacobsson@isv.liu.se
Contact: Claes Hallert, MD,PhD +46 70543 8282 Claes.Hallert@lio.se

Locations
Sweden
Norrkoping Hospital, Recruiting
Norrkoping, Sweden, S-601 82
Contact: Claes Hallert, MD, PhD    • +46 70 543 8282    Claes.Hallert@lio.se   
Contact: Maria Friedrichsen, MD, PhD    +46 101030000    • Maria.friedrichsen@liu.se   
Principal Investigator: Claes Hallert, MD, PhD         
Principal Investigator: Lisa Jacobsson, MSc RN         
Principal Investigator: Maria Friedrichsen, MD, PhD         
Sponsors and Collaborators
Medical Research Council of Southeast Sweden
Linkoeping University
Investigators
Study Director: Claes Hallert, MD, PhD Norrkoping Hospitalö

Publications:
Responsible Party: Norrkoping Hospital, Claes HallertMD PhD, Norrkoping Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01088152     History of Changes
Other Study ID Numbers: FORSS-80731
M218-08 ( Other Identifier: Ethics Committee at Linkoping University, Linkoping Sweden )
First Posted: March 17, 2010    Key Record Dates
Last Update Posted: March 17, 2010
Last Verified: January 2001

Keywords provided by Medical Research Council of Southeast Sweden:
Celiac disease
Education
Sweden
Gluten-free diet

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases