Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06424769
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-13
Brief Title:
Improving Outcomes and Reducing Disparities for Patients With Inflammatory Bowel Disease Through Epidemiology and Enhanced Disease Management
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Improving Outcomes and Reducing Disparities for Patients With Inflammatory Bowel Disease Through Epidemiology and Enhanced Disease Management PROMOTE IBD
Status:
RECRUITING
Status Verified Date:
2024-07
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:
PROMOTE IBD
Brief Summary:
The goal of this clinical trial is to learn whether IBD patients have better disease outcomes and feel more empowered to manage their condition if they have access to text messaging with their clinical team and if their symptoms are more regularly monitored through text-based surveys
Researchers will compare participants who have access to text-based monitoring communication and education to participants who have access to text-based education alone Researchers will also examine if different social and other non-medical factors impact IBD symptoms and quality of life
All participants will
complete 5 brief on-line surveys over 12 months about their IBD and social risk factors
receive IBD education content by text message up to 2 times a week
Some participants will also
receive additional surveys by text to monitor their IBD progression
have the opportunity to directly text message their IBD medical team
Researchers will compare participants who have access to text-based monitoring communication and education to participants who have access to text-based education alone Researchers will also examine if different social and other non-medical factors impact IBD symptoms and quality of life
All participants will
complete 5 brief on-line surveys over 12 months about their IBD and social risk factors
receive IBD education content by text message up to 2 times a week
Some participants will also
receive additional surveys by text to monitor their IBD progression
have the opportunity to directly text message their IBD medical team
Detailed Description:
Crohns disease CD and ulcerative colitis UC collectively referred to as inflammatory bowel diseases IBD are chronic diseases with no cure Patient activation defined as having the knowledge skill and confidence to manage ones health can improve outcomes in chronic diseases including IBD Tailored digital health interventions can facilitate proactive longitudinal care for IBD patients by improving patient activation promoting self-management and remote monitoring and can be automated and implemented at scale
The researchers are conducting a multi-center open-label randomized clinical trial to evaluate the effectiveness of a tailored digital health intervention versus usual care to improve disease management and patient activation among teenage and adult patients with IBD The researchers hypothesize the intervention will lead to higher patient activation improved outcomes and quality of life and reduced health disparities among children and adults with IBD Within the usual care arm researchers will measure Social Determinants of Health at enrollment and evaluate associations between these factors and time spent in remission over a 1-year follow-up period
Participants in both arms will complete electronic surveys at baseline and then quarterly thereafter for 12-months The baseline survey will include 1 basic demographic information 2 social risk assessment adapted from the Health-related Social Needs Screening Tool by the Centers for Medicare Medicaid Services CMS and the Centers for Disease Control and Prevention CDC National Health Interview Survey NHIS survey this measure will be completed by the parentguardian for pediatric participants 3 patient reported outcomes for ulcerative colitis and Crohns disease PRO-2-UC or PRO-2-CD 4 IBD-related quality of life Short Inflammatory Bowel Disease Questionnaire SIBDQ 5 IBD-related healthcare utilization 6 IBD-related medication adherence and 7 patient activation measure PAM Survey All of these except demographic questions will be repeated at 12 months Quarterly surveys at 3 6 and 9 months will only include questions on IBD patient-reported outcomes and unplanned healthcare utilization 8 questions with the addition of medication adherence questions and the PAM at 6-months 12 additional questions
In addition to these patient-reported data providers and research coordinator at each site will perform chart abstraction to identify specific clinical disease-level factors including disease severity and phenotype and treatment-level factors prior and current therapies
Participants in both arms will receive texts approximately twice a week containing curated educational content All participants will receive usual clinical care per discretion of their treating provider and will maintain usual healthcare interactions with the clinical team using their preferred method of interaction including phone or electronic communications within their Electronic Health Record EHR
Participants assigned to the intervention arm will receive enhanced electronic health care delivered through text messaging This includes short monthly check in surveys to assess IBD disease progression Survey cadence will increase to weekly for 4 weeks at a time if a participant reports severe symptoms This also includes the opportunity to communicate with their clinical team through text messaging
Among participants assigned to the usual care arm of the pragmatic trial a cohort analysis will evaluate associations between social risk and IBD natural history and outcomes
The researchers are conducting a multi-center open-label randomized clinical trial to evaluate the effectiveness of a tailored digital health intervention versus usual care to improve disease management and patient activation among teenage and adult patients with IBD The researchers hypothesize the intervention will lead to higher patient activation improved outcomes and quality of life and reduced health disparities among children and adults with IBD Within the usual care arm researchers will measure Social Determinants of Health at enrollment and evaluate associations between these factors and time spent in remission over a 1-year follow-up period
Participants in both arms will complete electronic surveys at baseline and then quarterly thereafter for 12-months The baseline survey will include 1 basic demographic information 2 social risk assessment adapted from the Health-related Social Needs Screening Tool by the Centers for Medicare Medicaid Services CMS and the Centers for Disease Control and Prevention CDC National Health Interview Survey NHIS survey this measure will be completed by the parentguardian for pediatric participants 3 patient reported outcomes for ulcerative colitis and Crohns disease PRO-2-UC or PRO-2-CD 4 IBD-related quality of life Short Inflammatory Bowel Disease Questionnaire SIBDQ 5 IBD-related healthcare utilization 6 IBD-related medication adherence and 7 patient activation measure PAM Survey All of these except demographic questions will be repeated at 12 months Quarterly surveys at 3 6 and 9 months will only include questions on IBD patient-reported outcomes and unplanned healthcare utilization 8 questions with the addition of medication adherence questions and the PAM at 6-months 12 additional questions
In addition to these patient-reported data providers and research coordinator at each site will perform chart abstraction to identify specific clinical disease-level factors including disease severity and phenotype and treatment-level factors prior and current therapies
Participants in both arms will receive texts approximately twice a week containing curated educational content All participants will receive usual clinical care per discretion of their treating provider and will maintain usual healthcare interactions with the clinical team using their preferred method of interaction including phone or electronic communications within their Electronic Health Record EHR
Participants assigned to the intervention arm will receive enhanced electronic health care delivered through text messaging This includes short monthly check in surveys to assess IBD disease progression Survey cadence will increase to weekly for 4 weeks at a time if a participant reports severe symptoms This also includes the opportunity to communicate with their clinical team through text messaging
Among participants assigned to the usual care arm of the pragmatic trial a cohort analysis will evaluate associations between social risk and IBD natural history and outcomes
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 |
|---|---|---|---|
| 855107 | OTHER | University of Pennsylvania | None |