Celiac Disease School for Women Living on a Gluten-free Diet (CDST)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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||Phase|
|Education of Patients Counseling Problem-Based Learning||Behavioral: Celiac school Behavioral: Usual care of celiac disease women||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Structured Education of Swedish Celiac Women Living on a Gluten-free Diet for Years|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||January 2009|
|Estimated Study Completion Date :||March 2010|
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.
- Subjective health and well-being [ Time Frame: 6 months ]Gastrointestinal symptoms and Psychological well-being
- Gastrointestinal symptoms and Psychological well-being [ Time Frame: 6 months ]Two questionnaires: Psychological General Well-Being Index and the Gastrointestinal Symptom Rating Scale.
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
|Contact: Lisa Jacobsson, MSc RNfirstname.lastname@example.org|
|Contact: Claes Hallert, MD,PhD||+46 70543 8282||Claes.Hallert@lio.se|
|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.email@example.com|
|Principal Investigator: Claes Hallert, MD, PhD|
|Principal Investigator: Lisa Jacobsson, MSc RN|
|Principal Investigator: Maria Friedrichsen, MD, PhD|
|Study Director:||Claes Hallert, MD, PhD||Norrkoping Hospitalö|