Education of PatientsCDSTNCT01088152
Celiac Disease School for Women Living on a Gluten-free Diet
A study testing Celiac school in people with Education of Patients and Counseling, run by Medical Research Council of Southeast Sweden at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Education of Patients, Counseling, Problem-Based Learning
- What is being tested?
- Celiac school
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2008to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 20 yrs or above with Celiac disease treated for at least five years
Who cannot join
- Anticipated inability to comply the trial protocol
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Norrkoping Hospital,
Norrköping, S-601 82
Claes Hallert, MD, PhD, • +46 70 543 8282, Claes.Hallert@lio.se
Maria Friedrichsen, MD, PhD, +46 101030000, • Maria.friedrichsen@liu.se
About this study
Official title: 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.
Read the 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.
- Conditions
- Education of Patients, Counseling, Problem-Based Learning
- Being tested
- Celiac school, Usual care of celiac disease women
- Keywords
- Celiac disease, Education, Sweden, Gluten-free diet
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celiac schoolBehavioural
Also called Patient education, Counselling
Structured education of adult celiac patients at 10 sessions.
Usual care of celiac disease womenBehavioural
Also called Coeliac disease guidelines
Written information corresponding to that offered when seeking medical advice for well treated celiac disease in the primary care.
| Study group | Role | What they receive |
|---|---|---|
| Usual care of celiac disease women | Active comparator | Written information corresponding to that offered when seeking medical advice for celiac disease in primary care Receives: Behavioral: Usual care of celiac disease women |
| Celiac School | Experimental | Structured education using problem-based learning at 10 sessions Receives: Behavioral: Celiac school |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective health and well-being
Gastrointestinal symptoms and Psychological well-being
Measured: 6 months
Secondary outcomes (1)
Gastrointestinal symptoms and Psychological well-being
Two questionnaires: Psychological General Well-Being Index and the Gastrointestinal Symptom Rating Scale.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study startAug 2008
- Primary completionJan 2009
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Education of PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Research Council of Southeast Sweden
- Sponsor type
- Other government
- Collaborators
- Linkoeping University
- Investigators
- Claes Hallert, MD, PhD, Study director, Norrkoping Hospitalö
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088152
- Sponsor's protocol ID
- FORSS-80731
- Other IDs
- M218-08
- Acronym
- CDST
- Status last verified
- Jan 2001
- First submitted
- 16 Mar 2010
- Last updated
- 17 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 12919466Sverker 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.
PubMed 15882379Midhagen 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.
PubMed 14499782Roos 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.
PubMed 16461026
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structured Education of Swedish Celiac Women Living on a Gluten-free Diet for Years
- ClinicalTrials.gov ID
- NCT01088152
- Acronym / sponsor ID
- CDST / FORSS-80731
- Conditions
- Education of Patients, Counseling, Problem-Based Learning
- Keywords
- Celiac disease, Education, Sweden, Gluten-free diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Medical Research Council of Southeast SwedenOther government
- Collaborators
- Linkoeping University
- Study start
- Aug 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Mar 2010 (estimated)
- First posted
- 17 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care of celiac disease women | Active comparator | Behavioral: Usual care of celiac disease womenWritten information corresponding to that offered when seeking medical advice for celiac disease in primary care |
| Celiac School | Experimental | Behavioral: Celiac schoolStructured education using problem-based learning at 10 sessions |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women aged 20 yrs or above with Celiac disease treated for at least five years
Key exclusion criteria (1 listed)
- Anticipated inability to comply the trial protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celiac schoolAlso: Patient education, CounsellingStructured education of adult celiac patients at 10 sessions. | Behavioural | Celiac School |
| Usual care of celiac disease womenAlso: Coeliac disease guidelinesWritten information corresponding to that offered when seeking medical advice for well treated celiac disease in the primary care. | Behavioural | Usual care of celiac disease women |
Primary outcome
Subjective health and well-being
Time frame: 6 months
Gastrointestinal symptoms and Psychological well-being
1 secondary outcome
Gastrointestinal symptoms and Psychological well-being
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2010.
- Background: PubMed 12919466Hallert 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.
- Background: PubMed 15882379Sverker 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.
- Background: PubMed 14499782Midhagen 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.
- Background: PubMed 16461026Roos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claes Hallert, MD, PhD study director
Norrkoping Hospitalö
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Celiac school in people with Education of Patients and Counseling, run by Medical Research Council of Southeast Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa Jacobsson, MSc RN (+4611363595, lisa.ring.jacobsson@isv.liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective health and well-being (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01088152, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2010.