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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2001 by Medical Research Council of Southeast Sweden.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Linkoeping University
Information provided by:
Medical Research Council of Southeast Sweden
ClinicalTrials.gov Identifier:
NCT01088152
First received: March 16, 2010
Last updated: NA
Last verified: January 2001
History: No changes posted

March 16, 2010
March 16, 2010
August 2008
January 2009   (final data collection date for primary outcome measure)
Subjective health and well-being [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Gastrointestinal symptoms and Psychological well-being
Same as current
No Changes Posted
Gastrointestinal symptoms and Psychological well-being [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Two questionnaires: Psychological General Well-Being Index and the Gastrointestinal Symptom Rating Scale.
Same as current
Not Provided
Not Provided
 
Celiac Disease School for Women Living on a Gluten-free Diet
Structured Education of Swedish Celiac Women Living on a Gluten-free Diet for Years

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Education of Patients
  • Counseling
  • Problem-Based Learning
  • Behavioral: Celiac school
    Structured education of adult celiac patients at 10 sessions.
    Other Names:
    • Patient education
    • Counselling
  • 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
  • Active Comparator: Usual care of celiac disease women
    Written information corresponding to that offered when seeking medical advice for celiac disease in primary care
    Intervention: Behavioral: Usual care of celiac disease women
  • Experimental: Celiac School
    Structured education using problem-based learning at 10 sessions
    Intervention: Behavioral: Celiac school

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
106
March 2010
January 2009   (final data collection date for primary outcome measure)

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
Female
20 Years and older
No
Contact: Lisa Jacobsson, MSc RN +4611363595 lisa.ring.jacobsson@isv.liu.se
Contact: Claes Hallert, MD,PhD +46 70543 8282 Claes.Hallert@lio.se
Sweden
 
NCT01088152
FORSS-80731, M218-08
Yes
Norrkoping Hospital, Claes HallertMD PhD, Norrkoping Hospital, Sweden
Medical Research Council of Southeast Sweden
Linkoeping University
Study Director: Claes Hallert, MD, PhD Norrkoping Hospitalö
Medical Research Council of Southeast Sweden
January 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP