Patient Education for Patients With Irritable Bowel Syndrome (IBS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2017-11-20

Brief Summary

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

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Detailed Description

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In this randomized controlled study in patients with irritable bowel syndrome (IBS) the investigators plan to compare the effects of a structured patient group education (IBS School), which previously has been evaluated and found to efficacious for symptom improvement (1-3), with a similar education provided via the internet in a non-inferiority design. The investigators hypothesize that structured patient education provided via the internet is not inferior compared to structured patient group education.

Men and women from 18 years of age, with IBS according to the Rome III criteria, who are referred from physicians in primary care and secondary/tertiary care to receive patient education will be included. The education, both the IBS School and the internet based version, will be managed at the GI outpatient clinic at Sahlgrenska University hospital in Gothenburg. Patients with an organic GI disease and/or with another disease potentially affecting the GI symptoms are excluded. Likewise, patients with a disability to communicate in the Swedish language or to use a computer and/or do not have access to a computer or internet are excluded.

Moreover, 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 invited in a block and 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 IBS School or to start the patient education via internet within two to three weeks. After the randomization all patients will receive a personal login to the database and an e-mail with information on how to log in and complete the questionnaires online. All questionnaires will be completed by the patients on-line, i.e. all data will be registered directly into the database.

The interventions:

Both interventions in the study are 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 IBS School consists of three, two hour sessions held once per week in a group setting with eight to ten patients in each group. A nurse and a dietician lead the education and issues are chosen with the aim to cover a wide spectrum of issues related to IBS. A lot of space is given for discussion within the group. At the first session, general information is provided about IBS, symptoms, pathophysiology and treatment options. At the second session, food related issues is discussed and at the third session the effects from other life style factors like stress, physical activity and relaxation is discussed.

The patient education provided via the internet covers the same areas of issues related to IBS that are covered in the structured group education. The participants in the internet group will receive and read information which is divided into three steps, once weekly. At the end of each treatment week the patients will have a contact via the internet with the nurse and dietician and thereby receive feedback on questions that were raised during the treatment week. The patients are also encouraged to attend (anonymously) a specific, closed internet forum where they have the opportunity to discuss and reflect over information material from the last week with other patients attending the internet based intervention. The time consumed to read the information and reflect is estimated to two hours weekly.

Conditions

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Patient Education IBS - Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Active Comparator: 1 Structured patients group intervention - IBS School Active Comparator: 2 Structured Patient education via Internet

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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IBS School

Patient education provided in a group setting

Group Type ACTIVE_COMPARATOR

Structured patient group education

Intervention Type BEHAVIORAL

Patient education in a group setting

Internet patient education

Patient education provided via the internet

Group Type ACTIVE_COMPARATOR

Education via Internet

Intervention Type BEHAVIORAL

Patient education via the internet

Interventions

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Structured patient group education

Patient education in a group setting

Intervention Type BEHAVIORAL

Education via Internet

Patient education via the internet

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* IBS according to the Rome III criteria

Exclusion Criteria

* organic GI disease and/or another disease potentially affecting the GI symptoms
* severe psychiatric disease due to potential problems to participate in a group intervention
* disability to communicate in the Swedish language
* disability to use a computer or not have access to a computer or internet

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No