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Irritable Bowel SyndromeNCT01403493

Multidisciplinary Versus a Nurse Based Patient Education For Patients With Irritable Bowel Syndrome

A study testing Patient education in people with Irritable Bowel Syndrome, run by Sahlgrenska University Hospital at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this randomized controlled study in patients with irritable bowel syndrome (IBS), the investigators plan to compare the effects of a multidisciplinary structured patient group education with a compressed nurse based structured patient group education. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Irritable Bowel Syndrome
What is being tested?
Patient education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteSweden
Study dates
Aug 2007to Jul 2011
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women 18 to 70 years old, with IBS according to the Rome II criteria.
  • Written informed consent

Who cannot join

  • An organic GI disease and/or with another disease potentially affecting the GI symptoms.
  • Severe psychiatric disease.

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • Dept of Internal Medicine, Sahlgrenska University Hospital

    Gothenburg, S413-45

Other trials in Sweden

About this study

Official title: A Comparison of a Short Nurse Based and a Long Multidisciplinary Version of Structured Patient Education in Irritable Bowel Syndrome.

In this randomized controlled study in patients with irritable bowel syndrome (IBS), the investigators plan to compare the effects of a multidisciplinary structured patient group education with a compressed nurse based structured patient group education. The effects of the interventions on gastrointestinal (GI) and psychological symptom severity, knowledge and quality of life will be assessed with validated questionnaires at baseline and 3, 6 and 12 months after the intervention.

Read the detailed description

In this randomized controlled study in patients with irritable bowel syndrome (IBS) we plan to compare the effects of a multidisciplinary, structured patient group education with a compressed, nurse based, structured patient group education. We plan to include men and women 18 to 70 years old, with IBS according to the Rome II criteria, who are referred from physicians in primary care and secondary/tertiary care to participate in the study. The education will be held at the GI out patient clinic at Sahlgrenska University hospital in Gothenburg. The patients will be informed about the positive results obtained in previous studies with different educational interventions. Patients with an organic GI disease and/or with another disease potentially affecting the GI symptoms are excluded. Likewise, patients with a severe psychiatric disease are excluded due to potential problems to participate in a group intervention. In order to allocate an equal number of patients to both of the interventions during the study, a number of up to 20 patients will be included in a block. The patients will be randomly divided into two groups with an equal number of patients in each group. The groups will then be randomized 1:1 to either start the multidisciplinary or the nurse based education within two to three weeks. The effects of the interventions on GI and psychological symptom severity, knowledge and quality of life will be assessed with validated questionnaires at baseline and 3, 6 and 12 months after the intervention:

  1. Perceived knowledge about IBS
  2. IBS Severity Scoring System (IBS-SSS)
  3. IBS Quality of Life (IBSQOL)
  4. Visceral Sensitivity Index (VSI)
  5. The Hospital Anxiety and Depression Scale (HAD)

The interventions:

The education is designed based on the self-efficacy theory , and the general theory of nursing. Moreover, the education is performed based on a biopsychosocial model considered to be important in functional GI disorders. The multidisciplinary education consists of six sessions held once per week in a group setting with eight to ten patients in each group. Five different health care professionals (nurse, gastroenterologist, dietician, physiotherapist and psychologist) are involved in the education, in order to cover a wide spectra of issues related to IBS. Each of the professionals will hold one session for two hours where a lot of space is given for discussion in the group. This intervention has been described in detail previously (Ringström et. al. BMC Gastroenterol 2009;9:10).

The nurse based education consists of three sessions held ones per week in a group setting with eight to ten patients in each group. A nurse, special trained in gastroenterology, is involved in this education, which covers the same spectra of issues related ti IBS as the multidisciplinary version.

Being tested
Patient education
Keywords
Irritable bowel syndrome, Patient education
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

Study groups in NCT01403493
Study groupRoleWhat they receive
Multidisciplinary patient educationActive comparatorA multidisciplinary (nurse, gastroenterologist, dietician, physiotherapist, psychologist) group education with six sessions for patients with IBS.
Receives: Behavioral: Patient education
Nurse based patient educationActive comparatorA nurse based patient education with three sessions for patients with IBS.
Receives: Behavioral: Patient education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effect on GI symptoms as measured by IBS-SSS and satisfactory relief of IBS symptoms

    Measured: Change from Baseline in GI Symptom severity and satisfactory relief of IBS symptoms at 3, 6 and 12 months.

Secondary outcomes (1)
  1. Effects on Quality of life (IBSQOL), Psychological symptoms (HAD), GI specific anxiety (VSI) and knowledge about IBS

    Measured: Change from Baseline in quality of life, psychological symptoms and knowledge at 3, 6 and 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2011 (estimated)
  2. Study startAug 2007
  3. Primary completionJul 2011
  4. Study completionJul 2011

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01403493
Sponsor's protocol ID
S-487-02 amendment
Status last verified
Jul 2011
First submitted
25 Jul 2011
Last updated
11 Aug 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Patient education in people with Irritable Bowel Syndrome, run by Sahlgrenska University Hospital 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 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 11 Aug 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 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?

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?

Effect on GI symptoms as measured by IBS-SSS and satisfactory relief of IBS symptoms (time frame: Change from Baseline in GI Symptom severity and satisfactory relief of IBS symptoms at 3, 6 and 12 months.). 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 11 Aug 2011.

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