Ignite Creation Date:
2024-05-06 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05168345
Status:
UNKNOWN
Last Update Posted:
2021-12-23
First Post:
2020-06-11
Brief Title:
A Prospective Patient Education Program for IBD Patients
Sponsor:
Tel-Aviv Sourasky Medical Center
Organization:
Tel-Aviv Sourasky Medical Center
Study Overview
Official Title:
A Prospective Patient Education Program for IBD Patients - Impact on Patient Disease Understanding Patient Reported Outcomes and Clinical Characteristics
Status:
UNKNOWN
Status Verified Date:
2021-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 n140 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 230 for Windows
All patients that will be fully adhering to the studys 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
Methods Study design An open label non-randomized clinical trial Study population IBD patients n140 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 230 for Windows
All patients that will be fully adhering to the studys 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None