Patient Education for Patients With Irritable Bowel Syndrome (IBS) (IBS)

March 8, 2018 updated by: Magnus Simrén, Sahlgrenska University Hospital, Sweden

Structured Patient Group Education Versus Structured Patient Education Via the Internet for Patients With Irritable Bowel Syndrome (IBS)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, S413-45
        • Dept of Internal Medicine, Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: IBS School
Patient education provided in a group setting
Behavioral: Structured patient group education
Patient education in a group setting
Active Comparator: Internet patient education
Patient education provided via the internet
Behavioral: Education via Internet
Patient education via the internet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of GI symptoms
Time Frame: Measuring change from Baseline and up to six months after the education
Measured with a questionnaire; Irritable Bowel Syndrome-severity scoring system (IBS-SSS). Five issues measure the severity of IBS symptoms on a scale, each ranging from 0 to 100. A total score is calculated ranging from 0 to 500. In this study the total score is used, the higher the score the worse severity of symptoms.
Measuring change from Baseline and up to six months after the education

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of Quality of life
Time Frame: Measuring change from Baseline and up to six months after the education
Measured with a questionnaires; Irritable Bowel Syndrome Quality Of Life (IBSQOL) is a disease-specific HRQOL instrument, including 30 items measuring nine dimensions of health, emotional functioning, mental health, sleep, energy, physical functioning, diet, social role, physical role and sexual relations. Raw scores are transformed into a scale of 0-100, with 100 representing the best possible quality of life scores for each of the nine dimensions.
Measuring change from Baseline and up to six months after the education
Change of Psychological symptoms
Time Frame: Measuring change from Baseline and up to six months after the education
Measured with a questionnaire; Hospital Anxiety and Depression scale (HAD). This scale consists of 14 items with seven items relating to anxiety and seven to depression. A four-graded scale was used (0-3), giving a total range from 0 to 21 on each subscale. The higher the score, the more pronounced the symptom. HAD was developed for nonpsychiatric medical patients to detect anxiety and depression.
Measuring change from Baseline and up to six months after the education
Change of GI specific anxiety
Time Frame: Measuring change from Baseline and up to six months after the education
Measured with a questionnaire; Visceral Sensitivity Index (VSI) which is a 15-item (each question ranging from 0 to 5) questionnaire designed to measure the degree of GI-specific anxiety in IBS. The total score ranges from 0 (no GI-specific anxiety) to 75 (severe GI-specific anxiety), and the higher the score, the higher the GI-specific anxiety
Measuring change from Baseline and up to six months after the education
Change of Perceived knowledge about IBS
Time Frame: Measuring change from Baseline and up to six months after the education
Measured with a Visual Analogue scale (VAS). The patients were asked to rate their perceived knowledge of IBS on a Visual Analog Scale (VAS). The scale comprised a 100-mm straight line with the extremes labeled 'No knowledge at all' and 'Very much knowledge'. The score ranges from 0 to 100 and the higher the score the more perceived knowledge of IBS.
Measuring change from Baseline and up to six months after the education

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sahlgrenska University Hospital, Sweden

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Magnus Simren, MD, Prof, Dept of internal medicine, Gothenburg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 20, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IBS patient education

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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