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
Recruitment status was Recruiting
Sponsor:
Medical Research Council of Southeast Sweden
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | March 16, 2010 | ||||||||
| Last Updated Date | March 16, 2010 | ||||||||
| Start Date ICMJE | August 2008 | ||||||||
| Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Subjective health and well-being [ Time Frame: 6 months ] [ Designated as safety issue: No ] Gastrointestinal symptoms and Psychological well-being |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Celiac Disease School for Women Living on a Gluten-free Diet | ||||||||
| Official Title ICMJE | Structured Education of Swedish Celiac Women Living on a Gluten-free Diet for Years | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 106 | ||||||||
| Estimated Completion Date | March 2010 | ||||||||
| Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 20 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Sweden | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01088152 | ||||||||
| Other Study ID Numbers ICMJE | FORSS-80731, M218-08 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Norrkoping Hospital, Claes HallertMD PhD, Norrkoping Hospital, Sweden | ||||||||
| Study Sponsor ICMJE | Medical Research Council of Southeast Sweden | ||||||||
| Collaborators ICMJE | Linkoeping University | ||||||||
| Investigators ICMJE |
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| Information Provided By | Medical Research Council of Southeast Sweden | ||||||||
| Verification Date | January 2001 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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