A Prospective Patient Education Program for IBD Patients - Impact on Patient Disease Understanding, Patient Reported Outcomes and Clinical Characteristics
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Self-Reported Outcome Measure (SF12) questionnaire
研究概览
简要总结
During the past few decades, key medical organizations have highlighted the importance of patient education and support. Evidence suggests that improving inflammatory bowel disease (IBD) patients' knowledge of their disease may empower patients to use more adaptive coping strategies and compliance with therapy and medical follow-up. Medical knowledge of disease pathophysiology and treatment are important determinants of early stage self-management in newly diagnosed IBD patients, and of adherence to therapy. Level of patient knowledge has been associated with significantly lower health care costs, possibly through improving patients behavioral choices leading to improved long-term clinical outcomes (such as disease activity, hospitalization and surgeries) and through preventive medicine, such as vaccinations, and screening for cancer prevention.
Despite availability of multiple alternatives for raising disease education levels, many adolescent and adult patients consistently show low levels of comprehension of their disease state and treatment regimen. The primary aim of this study is to evaluate the effect of a video based educational program for IBD patients on patient knowledge and understanding of their disease, patient reported outcomes and quality of life.
详细描述
To evaluate the effect of a video based educational program for IBD patients on patient knowledge and understanding of their disease, patient reported outcomes and quality of life
Methods Study design: An open label, non-randomized clinical trial. Study population: IBD patients (n=140) will be recruited from the clinical setting of the IBD clinic within the Tel Aviv Medical Center (TLVMC) Gastrointestinal (GI) department. Patients will be recruited to represent all stages of diagnosis and all patient age groups. This will be done by recruitment of six main participant groups stratified by age (18-23 years, 24-36 years, 42-52 years, 53-70 years) and disease duration (<1 year since diagnosis, ≥1 year since diagnosis)
Inclusion criteria
- Diagnosis of IBD and , other GI chronic diseases or healthy volunteers
- Age 18-70 years
- Minimal skills of computer and internet use
Exclusion criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of IBD, GI chronic diseases or healthy volunteers
- •Age 18-70 years
- •Minimal skills of computer and internet use
排除标准
- •Severe disease
- •Inability to sign an informed consent
- •Inability to complete the study protocol
- •score high on the IBD knowledge questionnaire (>80%) interventional phase
研究组 & 干预措施
IBD patients
Arm 1: IBD patients, patients of other chronic GI disease' and healthy volunteers
Both groups will be asked to fill in the "knowledge questionnaire" and the "self-assessment of knowledge questionnaire" once, during their routine visit to the GI department. Results of the questionnaire will be compared between the groups.
IBD Patient's knowledge will also be subjectively assessed by their treating physician during their routine clinical visit, and knowledge scores will be compared (physician and questionnaire). Patients who will agree, will be asked to fill in the knowledge questionnaire a second time after two weeks for reliability testing. Patients will be recruited to represent all stages of diagnosis and all patient age groups. This will be done by recruitment of six main participant groups stratified by age (18-23 years, 24-36 years, 42-52 years, 53-70 years) and disease duration (<1 year since diagnosis, ≥1 year since diagnosis)
干预措施: Course and web information (Other)
结局指标
主要结局
Self-Reported Outcome Measure (SF12) questionnaire
时间窗: 4 weeks
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. The SF-12 uses the same eight domains as the SF-36: 1. Limitations in physical activities because of health problems. 2. Limitations in social activities because of physical or emotional problems 3. Limitations in usual role activities because of physical health problems 4. Bodily pain 5. General mental health (psychological distress and well-being) 6. Limitations in usual role activities because of emotional problems 7. Vitality (energy and fatigue) 8. General health perceptions
Lifestyle questionnaire
时间窗: 4 weeks
To assess changes within the patients lifestyle. The questioner is designed as open ended questions and multiple choices questions designed to collect relating information to the lifestyle factors including: Levels of activity/ Alcohol consumption/ Smoking/ Stress levels/ Diet/
The Medication Adherence Report (MARS-5) questionnaire
时间窗: 4 weeks
The Medication Adherence Rating Scale (MARS) The MARS-5 is aimed to collect information regarding patient's level of adherence to the prescribed pharmacological therapy. It is a 5 item scale/ Each item is rated on a 5-point Likert type scale indicating the degree to which the item describes the patient's behavior.
Patient-Reported Outcomes Measurement (PROMIS ) questionnaire
时间窗: 4 weeks
Participants will undergo a multiple choice tests with questions relevant to the topic covered. participant will fill the following questioners at base line of the study (before taking the course) and at the end of the study (after 4 weeks). First Questioner out of the 5 is the PROMIS questionnaire: Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions.
Hospital Anxiety and Depression Scale (HADS) anxiety questionnaire
时间窗: 4 weeks
HADS focuses on non-physical symptoms so that it can be used to diagnose depression in people with significant physical ill-health. Any overlap, for instance impaired concentration secondary to pain rather than depression, is usually easy to separate on an individual basis. HADS does not include all of the diagnostic criteria of depression (Diagnostic and Statistical Manual of Mental Disorders, Fourth/Fifth Edition (DSM IV/V)) or all those required by the Health and Work Development Unit (HWDU) National Depression and Long Term Sickness Absence Screening Audit/ The questionnaire comprises seven questions for anxiety and seven questions for depression
次要结局
未报告次要终点
研究者
Eli Sprecher, MD
Director of clinical trails
Tel-Aviv Sourasky Medical Center