Clinical trial NCT05168345: A Prospective Patient Education Program for IBD Patients
Official title: A Prospective Patient Education Program for IBD Patients - Impact on Patient Disease Understanding, Patient Reported Outcomes and Clinical Characteristics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Educational Course
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2021-12-23
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Arm 1: IBD patients, patients of other chronic GI diseases' 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient-Reported Outcomes Measurement (PROMIS ) questionnaire
timeFrame: 4 weeks
measure: Self-Reported Outcome Measure (SF12) questionnaire
timeFrame: 4 weeks
measure: Lifestyle questionnaire
timeFrame: 4 weeks
measure: The Medication Adherence Report (MARS-5) questionnaire
timeFrame: 4 weeks
measure: Hospital Anxiety and Depression Scale (HADS) anxiety questionnaire
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Sourasky medical center (Ichilov)
Study officials:
References:
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citation: Kim AH, Roberts C, Feagan BG, Banerjee R, Bemelman W, Bodger K, Derieppe M, Dignass A, Driscoll R, Fitzpatrick R, Gaarentstroom-Lunt J, Higgins PD, Kotze PG, Meissner J, O'Connor M, Ran ZH, Siegel CA, Terry H, van Deen WK, van der Woude CJ, Weaver A, Yang SK, Sands BE, Vermeire S, Travis SP. Developing a Standard Set of Patient-Centred Outcomes for Inflammatory Bowel Disease-an International, Cross-disciplinary Consensus. J Crohns Colitis. 2018 Mar 28;12(4):408-418. doi: 10.1093/ecco-jcc/jjx161.
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