Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06221254
Status:
RECRUITING
Last Update Posted:
2024-01-24
First Post:
2023-08-31
Brief Title:
A Smartphone Application for Added Psychological Wellbeing in Crohns Disease
Sponsor:
Soroka University Medical Center
Organization:
Soroka University Medical Center
Study Overview
Official Title:
Israeli IBD Research Nucleus IIRN Consortium COBMINDEX Goes Forward- A Smartphone Application for Added Psychological Wellbeing in Crohns Disease
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
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:
COBMINDEX
Brief Summary:
Psychological intervention by COBMINDEX application to reduce psychological stress among CD patients fatigue and pain and improve the patients well being quality-of-life and disease-coping skills as well as improvement of the patients immunological profile and intestinal microbiome
Detailed Description:
200 patients will be randomly divided into two groups - 100 patients will learn and practice COBMINDEX by a human therapist-social worker and 100 patients will learn and practice COBMINDEX by a digital therapist using the COBMINDEX application
In the first 3-months there will be an assessment of patient progress following randomization to human therapist or digital therapist using the application for learning and practicing During this period the group of the human social-worker will have a limited access to the application dedicated for daily exercises and assessment
In the following 9-month period all patients will practice using the application each group by its permissions
There will be daily assessment of stress pain fatigue well-being and frequent assessments of patients medical psychological and immunological status
Throughout the trial adverse events and concomitant medications will be collected
In the first 3-months there will be an assessment of patient progress following randomization to human therapist or digital therapist using the application for learning and practicing During this period the group of the human social-worker will have a limited access to the application dedicated for daily exercises and assessment
In the following 9-month period all patients will practice using the application each group by its permissions
There will be daily assessment of stress pain fatigue well-being and frequent assessments of patients medical psychological and immunological status
Throughout the trial adverse events and concomitant medications will be collected
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2203-05901 | OTHER_GRANT | The Leona M and Harry B Helmsley Charitable Trust | None |
| SCRC22051 | OTHER | None | None |
| MOH_2023-04-30_012589 | REGISTRY | None | None |