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

NCT ID: NCT01088152

Last Updated: 2010-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Education of Patients Counseling Problem-Based Learning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual care of celiac disease women

Written information corresponding to that offered when seeking medical advice for celiac disease in primary care

Group Type ACTIVE_COMPARATOR

Usual care of celiac disease women

Intervention Type BEHAVIORAL

Written information corresponding to that offered when seeking medical advice for well treated celiac disease in the primary care.

Celiac School

Structured education using problem-based learning at 10 sessions

Group Type EXPERIMENTAL

Celiac school

Intervention Type BEHAVIORAL

Structured education of adult celiac patients at 10 sessions.

Interventions

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Celiac school

Structured education of adult celiac patients at 10 sessions.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Patient education Counselling Coeliac disease guidelines

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Linkoeping University

OTHER_GOV

Sponsor Role collaborator

Medical Research Council of Southeast Sweden

OTHER_GOV

Sponsor Role lead

Responsible Party

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Claes HallertMD PhD, Norrkoping Hospital, Sweden

Principal Investigators

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Claes Hallert, MD, PhD

Role: STUDY_DIRECTOR

Norrkoping Hospitalö

Locations

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Norrkoping Hospital,

Norrköping, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Lisa Jacobsson, MSc RN

Role: CONTACT

+4611363595

Claes Hallert, MD,PhD

Role: CONTACT

+46 70543 8282

Facility Contacts

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Claes Hallert, MD, PhD

Role: primary

• +46 70 543 8282

Maria Friedrichsen, MD, PhD

Role: backup

+46 101030000

References

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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.

Reference Type BACKGROUND
PMID: 12919466 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15882379 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14499782 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16461026 (View on PubMed)

Other Identifiers

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M218-08

Identifier Type: OTHER

Identifier Source: secondary_id

FORSS-80731

Identifier Type: -

Identifier Source: org_study_id

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