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临床试验/NCT03466281
NCT03466281已完成不适用

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

Sahlgrenska University Hospital, Sweden1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Change of GI symptoms

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •IBS according to the Rome III criteria

排除标准

  • •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

研究组 & 干预措施

IBS School

Active Comparator

Patient education provided in a group setting

干预措施: Structured patient group education (Behavioral)

Internet patient education

Active Comparator

Patient education provided via the internet

干预措施: Education via Internet (Behavioral)

结局指标

主要结局

Change of GI symptoms

时间窗: 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.

次要结局

  • Change of Psychological symptoms(Measuring change from Baseline and up to six months after the education)
  • Change of GI specific anxiety(Measuring change from Baseline and up to six months after the education)
  • Change of Perceived knowledge about IBS(Measuring change from Baseline and up to six months after the education)
  • Change of Quality of life(Measuring change from Baseline and up to six months after the education)

研究者

发起方
Sahlgrenska University Hospital, Sweden
申办方类型
Other
责任方
Principal Investigator
主要研究者

Magnus Simrén

Professor

Sahlgrenska University Hospital, Sweden

研究点 (1)

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