Irritable Bowel SyndromePhase 3NCT00305968
Evaluation of Patient Education in Irritable Bowel Syndrome
A Phase 3 study testing patient education in people with Irritable Bowel Syndrome, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
About 10% of the population in western countries suffer from abdominal pain and change of bowel habits - known as the irritable bowel syndrome. The patients suffer from low quality of life and they are often not well taken care of within the public healthcare system. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- patient education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2006to Jan 2008
- Phase
- Phase 3
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A diagnosis of Irritable Bowel Syndrome, verified by the Rome II criteria
- Must be able to participate in a education-group
Who cannot join
- Another GI-diagnosis or kind of surgery that may interfere with the symptoms of irritable bowel syndrome
- Serious, untreated psychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Patient Education in Patients With Irritable Bowel Syndrome - a Randomized Multi Center Study
About 10% of the population in western countries suffer from abdominal pain and change of bowel habits - known as the irritable bowel syndrome. The patients suffer from low quality of life and they are often not well taken care of within the public healthcare system. They often feel frustrated and seek both their family doctors, specialists and alternative medicine for help. Many patients feel they do not know enough about their disease, and the uncertainty may enhance bowel symptoms. We want to evaluate the effect of patient information and education in these patients.
Read the detailed description
The patients are enrolled in endoscopic clinics in 7 hospitals in Norway. They are randomized to receive intervention now (intervention group) or in 6 months (control group). The intervention is a 6 hour education about the irritable bowel syndrome, held by a experienced gastroenterologist at the local hospital.
Elements in this "school-day" includes symptoms, epidemiology, pathophysiology, treatment, nutritional advices.
The patients are evaluated at time: 0 months and 6 months (intervention group and control group), 12 months (control group) and after 2 years (both groups).
- Conditions
- Irritable Bowel Syndrome
- Being tested
- patient education
- Keywords
- Quality of life, Gastrointestinal symptoms, Health related costs
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient educationBehavioural
Patient education group
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of life
Measured: 6 months
Change in Gastrointestinal symptom score
Measured: 6 months
Secondary outcomes (2)
Change in health related costs
Measured: 6 months
Evaluation of further patient needs after education
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 posted22 Mar 2006 (estimated)
- Study startJan 2006
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Collaborators
- Sykehuset Telemark, The Hospital of Vestfold
- Responsible party
- Sponsor
- Investigators
- Jostein Sauar, PhD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00305968
- Sponsor's protocol ID
- SSHFIBS-1
- Status last verified
- Dec 2011
- First submitted
- 21 Mar 2006
- Last updated
- 21 Dec 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient Education in Patients With Irritable Bowel Syndrome - a Randomized Multi Center Study
- ClinicalTrials.gov ID
- NCT00305968
- Acronym / sponsor ID
- SSHFIBS-1
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Quality of life, Gastrointestinal symptoms, Health related costs
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Collaborators
- Sykehuset Telemark, The Hospital of Vestfold
- Study start
- Jan 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 22 Mar 2006 (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.
About 10% of the population in western countries suffer from abdominal pain and change of bowel habits - known as the irritable bowel syndrome. The patients suffer from low quality of life and they are often not well taken care of within the public healthcare system. They often feel frustrated and seek both their family doctors, specialists and alternative medicine for help. Many patients feel they do not know enough about their disease, and the uncertainty may enhance bowel symptoms. We want to evaluate the effect of patient information and education in these patients.
Detailed description
The patients are enrolled in endoscopic clinics in 7 hospitals in Norway. They are randomized to receive intervention now (intervention group) or in 6 months (control group). The intervention is a 6 hour education about the irritable bowel syndrome, held by a experienced gastroenterologist at the local hospital.
Elements in this "school-day" includes symptoms, epidemiology, pathophysiology, treatment, nutritional advices.
The patients are evaluated at time: 0 months and 6 months (intervention group and control group), 12 months (control group) and after 2 years (both groups).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A diagnosis of Irritable Bowel Syndrome, verified by the Rome II criteria
- Must be able to participate in a education-group
Key exclusion criteria (2 listed)
- Another GI-diagnosis or kind of surgery that may interfere with the symptoms of irritable bowel syndrome
- Serious, untreated psychiatric disorder
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 |
|---|---|---|
| patient educationPatient education group | Behavioural | – |
Primary outcome
Change in Quality of life
Time frame: 6 months
Change in Gastrointestinal symptom score
Time frame: 6 months
2 secondary outcomes
Change in health related costs
Time frame: 6 months
Evaluation of further patient needs after education
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2011.
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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.
Jostein Sauar, PhD study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing patient education in people with Irritable Bowel Syndrome, run by Sorlandet Hospital HF at 1 site in Norway.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 21 Dec 2011. 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 Norway. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of life (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2011.