A Prospective Patient Education Program for IBD Patients

NCT05168345 | Unknown DMC

• 1 other identifier: 0285-18
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Educational Course

Outcome Measures

Primary Outcomes (5)

• Patient-Reported Outcomes Measurement (PROMIS ) questionnaire

  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.

  4 weeks

• Self-Reported Outcome Measure (SF12) questionnaire

  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

  4 weeks

• Lifestyle questionnaire

  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/

  4 weeks

• The Medication Adherence Report (MARS-5) questionnaire

  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.

  4 weeks

• Hospital Anxiety and Depression Scale (HADS) anxiety questionnaire

  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

  4 weeks

Study Arms (1)

IBD patients

EXPERIMENTAL

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)

Other: Course and web information

Interventions

Course and web information OTHER

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.

IBD patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Sourasky medical center (Ichilov)

Tel Aviv, Israel

RECRUITING

Related Publications (11)

• 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.

  PMID: 21681113 BACKGROUND

• 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.

  PMID: 24216568 RESULT

• 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.

  PMID: 26501880 RESULT

• 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.

  PMID: 25636120 RESULT

• 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.

  PMID: 22374585 RESULT

• 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.

  PMID: 22568682 RESULT

• 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.

  PMID: 29216349 RESULT

• 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.

  PMID: 27542132 RESULT

• 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.

  PMID: 29026602 RESULT

• 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.

  PMID: 25853211 RESULT

• 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.

  PMID: 10606319 RESULT

Central Study Contacts

Nitsan Maharshak, MD

CONTACT

0366924849; nitsanm@tlvmc.gov.il

Naomi Fliss, Phd

CONTACT

036694849; naomifl@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of clinical trails

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: December 23, 2021
• Study Start: July 1, 2019
• Primary Completion: March 10, 2022
• Study Completion: March 10, 2022
• Last Updated: December 23, 2021

Record last verified: 2021-12

Locations

IL (1)