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

Structured Education of Swedish Celiac Women Living on a Gluten-free Diet for Years

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.

Study Overview

• Status: Unknown
• Conditions: Counseling; Education of Patients; Problem-Based Learning
• Intervention / Treatment: Behavioral: Usual care of celiac disease women; Behavioral: Celiac school

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.

• Study Type: Interventional
• Enrollment (Anticipated): 106
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa Jacobsson, MSc RN; Phone Number: +4611363595; Email: lisa.ring.jacobsson@isv.liu.se
• Study Contact Backup: Name: Claes Hallert, MD,PhD; Phone Number: +46 70543 8282; Email: Claes.Hallert@lio.se

Study Locations

• Sweden
  • Norrkoping, Sweden, S-601 82
    • Recruiting
    • Norrkoping Hospital,
    • Contact: Claes Hallert, MD, PhD; Phone Number: • +46 70 543 8282; Email: Claes.Hallert@lio.se
    • Contact: Maria Friedrichsen, MD, PhD; Phone Number: +46 101030000; Email: • Maria.friedrichsen@liu.se
    • Principal Investigator: Claes Hallert, MD, PhD
    • Principal Investigator: Lisa Jacobsson, MSc RN
    • Principal Investigator: Maria Friedrichsen, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective health and well-being	Gastrointestinal symptoms and Psychological well-being	6 months

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Medical Research Council of Southeast Sweden
• Collaborators: Linkoeping University
• Investigators: Study Director: Claes Hallert, MD, PhD, Norrkoping Hospitalö

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): January 1, 2009
• Study Completion (Anticipated): March 1, 2010

Study Registration Dates

• First Submitted: March 16, 2010
• First Submitted That Met QC Criteria: March 16, 2010
• First Posted (Estimate): March 17, 2010

Study Record Updates

• Last Update Posted (Estimate): March 17, 2010
• Last Update Submitted That Met QC Criteria: March 16, 2010
• Last Verified: January 1, 2001

More Information

Terms related to this study

• Keywords: Education; Gluten-free diet; Sweden; Celiac disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Celiac Disease
• Other Study ID Numbers: FORSS-80731; M218-08 (Other Identifier: Ethics Committee at Linkoping University, Linkoping Sweden)