A Prospective Patient Education Program for IBD Patients

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Educational Course

Treatments: Other: Course and web information

Study type: Interventional

Funder types: Other

Identifiers

NCT05168345

0285-18

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Diagnosis of IBD, GI chronic diseases or healthy volunteers
• Age 18-70 years
• Minimal skills of computer and internet use

Exclusion criteria

• Severe disease
• Inability to sign an informed consent
• Inability to complete the study protocol
• score high on the IBD knowledge questionnaire (>80%) interventional phase

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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140 participants in 1 patient group

IBD patients

Experimental group

Description:

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)

Treatment:

Other: Course and web information