Educational Course Clinical Trial
Official title:
A Prospective Patient Education Program for IBD Patients - Impact on Patient Disease Understanding, Patient Reported Outcomes and Clinical Characteristics
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.
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 1. Diagnosis of IBD and , other GI chronic diseases or healthy volunteers 2. Age 18-70 years 3. Minimal skills of computer and internet use Exclusion criteria 1. Severe disease - malignant disease, hepatic failure, renal failure, cardiovascular, metabolic, neurological disease 2. Inability to sign an informed consent 3. Inability to complete the study protocol 4. For the intervention phase of the study, IBD patients will be excluded if they score high on the IBD knowledge questionnaire (>80%) Withdrawal from the study 1. Inability to complete the study protocol Methods Eligible patients will sign an informed consent form after being informed of the study protocol. IBD knowledge questionnaire validation The validation process of the study questionnaire will be conducted on the entire study population. Statistical analysis: All statistical analyses will be performed using statistical software platform (SPSS) version 23.0 for Windows. All patients that will be fully adhering to the study's protocol (considered as preforming ≥ 80% of exercises) will be included in data analysis. In addition, there will be intention-to-treat analysis that will include patients who will be excluded because of non-adherence to the intervention. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01621282 -
Running Successful Journal Club
|
Phase 2/Phase 3 |