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| ID | Type | Description | Link |
|---|---|---|---|
| M218-08 | Other Identifier | Ethics Committee at Linkoping University, Linkoping Sweden |
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| Name | Class |
|---|---|
| Linkoeping University | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care of celiac disease women | Active Comparator | Written information corresponding to that offered when seeking medical advice for celiac disease in primary care |
|
| Celiac School | Experimental | Structured education using problem-based learning at 10 sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celiac school | Behavioral | Structured education of adult celiac patients at 10 sessions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective health and well-being | Gastrointestinal symptoms and Psychological well-being | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal symptoms and Psychological well-being | Two questionnaires: Psychological General Well-Being Index and the Gastrointestinal Symptom Rating Scale. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Jacobsson, MSc RN | Contact | +4611363595 | lisa.ring.jacobsson@isv.liu.se | |
| Claes Hallert, MD,PhD | Contact | +46 70543 8282 | Claes.Hallert@lio.se |
| Name | Affiliation | Role |
|---|---|---|
| Claes Hallert, MD, PhD | Norrkoping Hospitalö | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Norrkoping Hospital, | Recruiting | Norrköping | S-601 82 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12919466 | Background | 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. | |
| 15882379 | Background | Sverker 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. |
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| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D010353 | Patient Education as Topic |
| D003376 | Counseling |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Usual care of celiac disease women | Behavioral | Written information corresponding to that offered when seeking medical advice for well treated celiac disease in the primary care. |
|
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| 14499782 | Background | Midhagen 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. |
| 16461026 | Background | Roos 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. |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |