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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
Sponsor:
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
  Purpose

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 Intervention
Education of Patients
Counseling
Problem-Based Learning
 Behavioral: Celiac school
Behavioral: Usual care of celiac disease women

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Structured Education of Swedish Celiac Women Living on a Gluten-free Diet for Years

Resource links provided by NLM:

MedlinePlus related topics: Celiac Disease
U.S. FDA Resources

Further study details as provided by Medical Research Council of Southeast Sweden:

Primary Outcome Measures:
  • Subjective health and well-being [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Gastrointestinal symptoms and Psychological well-being


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 106
Study Start Date: August 2008
Estimated Study Completion Date: March 2010
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • Patient education
  • Counselling

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088152

Contacts
Contact: Lisa Jacobsson, MSc RN +4611363595 lisa.ring.jacobsson@isv.liu.se
Contact: Claes Hallert, MD,PhD +46 70543 8282 Claes.Hallert@lio.se

Locations
Sweden
Norrkoping Hospital, Recruiting
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.friedrichsen@liu.se    
Principal Investigator: Claes Hallert, MD, PhD            
Principal Investigator: Lisa Jacobsson, MSc RN            
Principal Investigator: Maria Friedrichsen, MD, PhD            
Sponsors and Collaborators
Medical Research Council of Southeast Sweden
Linkoeping University
Investigators
Study Director: Claes Hallert, MD, PhD Norrkoping Hospitalö
  More Information

Publications:

Responsible Party: Norrkoping Hospital, Claes HallertMD PhD, Norrkoping Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01088152     History of Changes
Other Study ID Numbers: FORSS-80731, M218-08
Study First Received: March 16, 2010
Last Updated: March 16, 2010
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Medical Research Council of Southeast Sweden:
Celiac disease
Education
Sweden
Gluten-free diet

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on May 16, 2013