A Prospective Patient Education Program for IBD Patients
NCT ID: NCT05168345
Last Updated: 2021-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
140 participants
INTERVENTIONAL
2019-07-01
2022-03-10
Brief Summary
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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
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
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.
SUPPORTIVE_CARE
NONE
Study Groups
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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)
Course and web information
The interventional phase of the study will be conducted on IBD patients only. Patients will undergo two interventional periods which will include:
1. Self-selected information from the internet - patients will be asked to independently search the web for information regarding the categories of information which are discussed in the online course.
2. An online, interactive IBD course. Lectures will be passed by the multidisciplinary team of the IBD Center which includes IBD gastroenterologists, an IBD nurse, an IBD dietitian, and a social worker.
Interventions
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Course and web information
The interventional phase of the study will be conducted on IBD patients only. Patients will undergo two interventional periods which will include:
1. Self-selected information from the internet - patients will be asked to independently search the web for information regarding the categories of information which are discussed in the online course.
2. An online, interactive IBD course. Lectures will be passed by the multidisciplinary team of the IBD Center which includes IBD gastroenterologists, an IBD nurse, an IBD dietitian, and a social worker.
Eligibility Criteria
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Inclusion Criteria
* Age 18-70 years
* Minimal skills of computer and internet use
Exclusion Criteria
* Inability to sign an informed consent
* Inability to complete the study protocol
* score high on the IBD knowledge questionnaire (\>80%) interventional phase
18 Years
70 Years
ALL
Yes
Sponsors
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Tel-Aviv Sourasky Medical Center
OTHER_GOV
Responsible Party
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Eli Sprecher, MD
Director of clinical trails
Locations
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Sourasky medical center (Ichilov)
Tel Aviv, , Israel
Countries
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Central Contacts
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Facility Contacts
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Dr. Nitsan Maharshak, MD
Role: primary
References
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Fishman LN, Houtman D, van Groningen J, Arnold J, Ziniel S. Medication knowledge: an initial step in self-management for youth with inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 2011 Dec;53(6):641-5. doi: 10.1097/MPG.0b013e3182285316.
Wardle RA, Mayberry JF. Patient knowledge in inflammatory bowel disease: the Crohn's and Colitis Knowledge Score. Eur J Gastroenterol Hepatol. 2014 Jan;26(1):1-5. doi: 10.1097/MEG.0b013e328365d21a.
Tae CH, Jung SA, Moon HS, Seo JA, Song HK, Moon CM, Kim SE, Shim KN, Jung HK. Importance of Patients' Knowledge of Their Prescribed Medication in Improving Treatment Adherence in Inflammatory Bowel Disease. J Clin Gastroenterol. 2016 Feb;50(2):157-62. doi: 10.1097/MCG.0000000000000431.
Colombara F, Martinato M, Girardin G, Gregori D. Higher levels of knowledge reduce health care costs in patients with inflammatory bowel disease. Inflamm Bowel Dis. 2015 Mar;21(3):615-22. doi: 10.1097/MIB.0000000000000304.
van Groningen J, Ziniel S, Arnold J, Fishman LN. When independent healthcare behaviors develop in adolescents with inflammatory bowel disease. Inflamm Bowel Dis. 2012 Dec;18(12):2310-4. doi: 10.1002/ibd.22937. Epub 2012 Feb 28.
Selinger CP, Eaden J, Selby W, Jones DB, Katelaris P, Chapman G, McDonald C, McLaughlin J, Leong RW, Lal S. Patients' knowledge of pregnancy-related issues in inflammatory bowel disease and validation of a novel assessment tool ('CCPKnow'). Aliment Pharmacol Ther. 2012 Jul;36(1):57-63. doi: 10.1111/j.1365-2036.2012.05130.x. Epub 2012 May 9.
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.
Graff LA, Sexton KA, Walker JR, Clara I, Targownik LE, Bernstein CN. Validating a Measure of Patient Self-efficacy in Disease Self-management Using a Population-based IBD Cohort: The IBD Self-efficacy Scale. Inflamm Bowel Dis. 2016 Sep;22(9):2165-72. doi: 10.1097/MIB.0000000000000856.
Engel T, Ungar B, Ben-Haim G, Levhar N, Eliakim R, Ben-Horin S. Re-phrasing the question: A simple tool for evaluation of adherence to therapy in patients with inflammatory bowel disease. United European Gastroenterol J. 2017 Oct;5(6):880-886. doi: 10.1177/2050640616687838. Epub 2017 Jan 11.
Spiegel BM, Hays RD, Bolus R, Melmed GY, Chang L, Whitman C, Khanna PP, Paz SH, Hays T, Reise S, Khanna D. Corrigendum: development of the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) gastrointestinal symptom scales. Am J Gastroenterol. 2015 Apr;110(4):608. doi: 10.1038/ajg.2015.62. No abstract available.
Eaden JA, Abrams K, Mayberry JF. The Crohn's and Colitis Knowledge Score: a test for measuring patient knowledge in inflammatory bowel disease. Am J Gastroenterol. 1999 Dec;94(12):3560-6. doi: 10.1111/j.1572-0241.1999.01536.x.
Other Identifiers
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0285-18
Identifier Type: -
Identifier Source: org_study_id