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

Primary Purpose

Education of Patients, Counseling, Problem-Based Learning

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Celiac school
Usual care of celiac disease women
Sponsored by
Medical Research Council of Southeast Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Education of Patients focused on measuring Celiac disease, Education, Sweden, Gluten-free diet

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Norrkoping Hospital,Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual care of celiac disease women

Celiac School

Arm Description

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

Structured education using problem-based learning at 10 sessions

Outcomes

Primary Outcome Measures

Subjective health and well-being
Gastrointestinal symptoms and Psychological well-being

Secondary Outcome Measures

Gastrointestinal symptoms and Psychological well-being
Two questionnaires: Psychological General Well-Being Index and the Gastrointestinal Symptom Rating Scale.

Full Information

First Posted
March 16, 2010
Last Updated
March 16, 2010
Sponsor
Medical Research Council of Southeast Sweden
Collaborators
Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT01088152
Brief Title
Celiac Disease School for Women Living on a Gluten-free Diet
Acronym
CDST
Official Title
Structured Education of Swedish Celiac Women Living on a Gluten-free Diet for Years
Study Type
Interventional

2. Study Status

Record Verification Date
January 2001
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
March 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Medical Research Council of Southeast Sweden
Collaborators
Linkoeping University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Education of Patients, Counseling, Problem-Based Learning
Keywords
Celiac disease, Education, Sweden, Gluten-free diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual care of celiac disease women
Arm Type
Active Comparator
Arm Description
Written information corresponding to that offered when seeking medical advice for celiac disease in primary care
Arm Title
Celiac School
Arm Type
Experimental
Arm Description
Structured education using problem-based learning at 10 sessions
Intervention Type
Behavioral
Intervention Name(s)
Celiac school
Other Intervention Name(s)
Patient education, Counselling
Intervention Description
Structured education of adult celiac patients at 10 sessions.
Intervention Type
Behavioral
Intervention Name(s)
Usual care of celiac disease women
Other Intervention Name(s)
Coeliac disease guidelines
Intervention Description
Written information corresponding to that offered when seeking medical advice for well treated celiac disease in the primary care.
Primary Outcome Measure Information:
Title
Subjective health and well-being
Description
Gastrointestinal symptoms and Psychological well-being
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Gastrointestinal symptoms and Psychological well-being
Description
Two questionnaires: Psychological General Well-Being Index and the Gastrointestinal Symptom Rating Scale.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Jacobsson, MSc RN
Phone
+4611363595
Email
lisa.ring.jacobsson@isv.liu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Claes Hallert, MD,PhD
Phone
+46 70543 8282
Email
Claes.Hallert@lio.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claes Hallert, MD, PhD
Organizational Affiliation
Norrkoping Hospitalö
Official's Role
Study Director
Facility Information:
Facility Name
Norrkoping Hospital,
City
Norrkoping
ZIP/Postal Code
S-601 82
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claes Hallert, MD, PhD
Phone
• +46 70 543 8282
Email
Claes.Hallert@lio.se
First Name & Middle Initial & Last Name & Degree
Maria Friedrichsen, MD, PhD
Phone
+46 101030000
Email
• Maria.friedrichsen@liu.se
First Name & Middle Initial & Last Name & Degree
Claes Hallert, MD, PhD
First Name & Middle Initial & Last Name & Degree
Lisa Jacobsson, MSc RN
First Name & Middle Initial & Last Name & Degree
Maria Friedrichsen, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
12919466
Citation
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.
Results Reference
background
PubMed Identifier
15882379
Citation
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.
Results Reference
background
PubMed Identifier
14499782
Citation
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.
Results Reference
background
PubMed Identifier
16461026
Citation
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.
Results Reference
background

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

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