Educational CourseNCT05168345
A Prospective Patient Education Program for IBD Patients
A study testing Course and web information in people with Educational Course, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Educational Course
- What is being tested?
- Course and web information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2019to 10 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of IBD, GI chronic diseases or healthy volunteers
- Age 18-70 years
- Minimal skills of computer and internet use
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sourasky medical center (Ichilov)
Tel Aviv
Dr. Nitsan Maharshak, MD
About this study
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.
Read the 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
- Diagnosis of IBD and , other GI chronic diseases or healthy volunteers
- Age 18-70 years
- Minimal skills of computer and internet use
Exclusion criteria
- Severe disease - malignant disease, hepatic failure, renal failure, cardiovascular, metabolic, neurological disease
- Inability to sign an informed consent
- Inability to complete the study protocol
- 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
- 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
- Educational Course
- Being tested
- Course and web information
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Course and web informationOther
The interventional phase of the study will be conducted on IBD patients only. Patients will undergo two interventional periods which will include:
- 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Course and web information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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:
- Limitations in physical activities because of health problems.
- Limitations in social activities because of physical or emotional problems
- Limitations in usual role activities because of physical health problems
- Bodily pain
- General mental health (psychological distress and well-being)
- Limitations in usual role activities because of emotional problems
- Vitality (energy and fatigue)
- General health perceptions
Measured: 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/
Measured: 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.
Measured: 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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start1 Jul 2019
- Primary completion10 Mar 2022 (estimated)
- Study completion10 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Educational CourseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eli Sprecher, MD, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168345
- Sponsor's protocol ID
- 0285-18
- Status last verified
- Dec 2021
- First submitted
- 11 Jun 2020
- Last updated
- 23 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21681113Wardle 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.
PubMed 24216568Tae 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.
PubMed 26501880Colombara 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.
PubMed 25636120van 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.
PubMed 22374585Selinger 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.
PubMed 22568682Kim 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.
PubMed 29216349Graff 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.
PubMed 27542132Engel 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.
PubMed 29026602Spiegel 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.
PubMed 25853211Eaden 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.
PubMed 10606319
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Patient Education Program for IBD Patients - Impact on Patient Disease Understanding, Patient Reported Outcomes and Clinical Characteristics
- ClinicalTrials.gov ID
- NCT05168345
- Acronym / sponsor ID
- 0285-18
- Conditions
- Educational Course
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 10 Mar 2022 (estimated)
- Study completion
- 10 Mar 2022 (estimated)
- First posted
- 23 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Diagnosis of IBD and , other GI chronic diseases or healthy volunteers
- Age 18-70 years
- Minimal skills of computer and internet use
Exclusion criteria
- Severe disease - malignant disease, hepatic failure, renal failure, cardiovascular, metabolic, neurological disease
- Inability to sign an informed consent
- Inability to complete the study protocol
- 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
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| IBD patients | Experimental | Other: Course and web informationArm 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) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of IBD, GI chronic diseases or healthy volunteers
- Age 18-70 years
- Minimal skills of computer and internet use
Key exclusion criteria (4 listed)
- Severe disease
- Inability to sign an informed consent
- Inability to complete the study protocol
- score high on the IBD knowledge questionnaire (>80%) interventional phase
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Course and web informationThe 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. | Other | IBD patients |
Primary outcome
Patient-Reported Outcomes Measurement (PROMIS ) questionnaire
Time frame: 4 weeks
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.
Self-Reported Outcome Measure (SF12) questionnaire
Time frame: 4 weeks
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
Lifestyle questionnaire
Time frame: 4 weeks
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/
The Medication Adherence Report (MARS-5) questionnaire
Time frame: 4 weeks
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.
Hospital Anxiety and Depression Scale (HADS) anxiety questionnaire
Time frame: 4 weeks
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
- Background: PubMed 21681113Fishman 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.
- Results publication: PubMed 24216568Wardle 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.
- Results publication: PubMed 26501880Tae 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.
- Results publication: PubMed 25636120Colombara 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.
- Results publication: PubMed 22374585van 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.
- Results publication: PubMed 22568682Selinger 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.
- Results publication: PubMed 29216349Kim 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.
- Results publication: PubMed 27542132Graff 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.
- Results publication: PubMed 29026602Engel 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.
- Results publication: PubMed 25853211Spiegel 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.
- Results publication: PubMed 10606319Eaden 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Course and web information in people with Educational Course, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nitsan Maharshak, MD (0366924849, nitsanm@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcomes Measurement (PROMIS ) questionnaire (time frame: 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05168345, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2021.