Inflammatory Bowel DiseasesPROMOTE IBDNCT06424769
Improving Outcomes and Reducing Disparities for Patients With Inflammatory Bowel Disease Through Epidemiology and Enhanced Disease Management
A study testing Enhanced Digital Care and Education in people with Inflammatory Bowel Diseases and Crohn Disease, run by University of North Carolina, Chapel Hill at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- What is being tested?
- Enhanced Digital Care and Education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 900 participants
- Where
- 9 sitesUnited States
- Study dates
- 24 Jul 2024to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 13+ years old with IBD (Crohn's disease, ulcerative colitis, indeterminant colitis).
- Followed at a participating site with an office visit (in-person or virtual) within the preceding 12 months.
- Have access to a mobile phone and willing and able to receive and respond to text messages.
- Willing to answer questions on electronic surveys.
- Have the ability to read text messages and answer surveys in English or Spanish.
Who cannot join
- IBD patients s/p surgery with a current pouch or ostomy.
- Unable to provide informed consent and child assent for minors.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites
Morehouse School of Medicine
Atlanta, Georgia, 30310
Boston Medical Center
Boston, Massachusetts, 02118
UNC-Chapel Hill School of Medicine
Chapel Hill, North Carolina, 27599
Atrium Health Levine Children's
Charlotte, North Carolina, 28203
NYU Langone Health Lake Success
Lake Success, New York, 11042
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of California San Diego
San Diego, California, 92093
University of California San Francisco Benioff Children's Hospital
San Francisco, California, 94158
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
About this study
Official title: Improving Outcomes and Reducing Disparities for Patients With Inflammatory Bowel Disease Through Epidemiology and Enhanced Disease Management (PROMOTE IBD)
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.
Read more
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.
Read the detailed description
Crohn's 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 one's 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 parent/guardian for pediatric participants), 3) patient reported outcomes for ulcerative colitis and Crohn's 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.
- Being tested
- Enhanced Digital Care, Education
- Keywords
- Text Messaging, Symptom Monitoring, Social Risk Factors
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Digital CareOther
Participants will receive brief check-in surveys about their IBD symptoms once a month, via text messaging. If the survey response indicates significant symptoms, an alert will be sent to the participant's IBD care team and participant will receive more frequent surveys (weekly) over the next month. Participants and their IBD clinical team will be able to communicate by text for non-emergency IBD-related questions.
EducationOther
Participants will receive education texts about IBD from trusted sources approximately twice a week. Topics will include: diet, medication adherence, fatigue, preventative care and other relevant issues.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Digital Care Arm | Active comparator | Participants will receive brief check-in surveys about their IBD symptoms minimally once a month, via text messaging. Participants will also receive IBD educational text messages twice each week. Receives: Other: Enhanced Digital Care; Other: Education |
| Specialized Education Arm | Placebo comparator | Participants in this arm will receive IBD educational text messages twice each week. Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Activation using PAM
The primary outcome is the change in patient activation from baseline, with a 4-point improvement on Patient Activation Measure (PAM) scale considered a minimal clinically important difference (MCID). Patient activation is an assessment of the knowledge, skills and confidence of patients to manage their health. In chronic diseases, activated patients are more likely to adhere to treatment, perform regular self-monitoring at home and obtain regular chronic care. Activated patients are also more likely to make healthier lifestyle choices and preventative behaviors. Longitudinal improvement in patient activation measures is associated with improved clinical outcomes, decreased unplanned healthcare utilization and lower costs.
Measured: Baseline, 12 months
Secondary outcomes (3)
Remission at 52 Weeks
Proportion of participants achieving Patient Reported Outcome (PRO) remission without steroids at end of study (among participants with active disease at baseline). This will be assessed for ulcerative colitis patients based on the 2-point PRO2-UC and assessed for Crohn's disease patients using the 2-point PRO2-CD. The PRO2-UC consists of the stool frequency and rectal bleeding subscores of the Mayo Clinic Score, and remission is defined as absence of rectal bleeding (rectal bleeding score = 0) and normal or near normal stool frequency (stool frequency score ≤1). The PRO2-CD consists of the 2 Crohn's Disease Activity Index (CDAI) component items: daily stool frequency and abdominal pain, and remission is defined as mean daily score of abdominal pain score ≤1 and stool frequency score ≤3.
Measured: 12 months
IBD-Related Quality of Life
IBD-related quality of life will be measured using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), a validated, 10-item questionnaire which measures quality of life across physical, social and emotional domains in patients with IBD. The score on this questionnaire ranges from 10 to 70, with a minimal clinically important difference (MCID) of 9 points. This will be measured at baseline and at 12 months.
Measured: up to 12 months
Unplanned Healthcare Utilization
Unplanned healthcare utilization (defined as IBD-related Emergency Department (ED) visit, hospitalization, or abdominal/perianal surgery for IBD) will be measured by self-report every 3 months (Baseline and months 3, 6, 9, and 12).
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start24 Jul 2024
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (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 Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- After completing their baseline survey, consented participants will be randomized to usual care and intervention groups in a 2:1 allocation ratio. A computer-generated, centralized randomization with permuted block randomization within sites to ensure allocation concealment will be utilized.
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Michael D Kappelman, MD, MPH, Principal investigator, University of North Carolina, Chapel HillSiddharth Singh, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424769
- Sponsor's protocol ID
- 24-0699
- Other IDs
- 855107
- Acronym
- PROMOTE IBD
- Status last verified
- Oct 2025
- First submitted
- 13 May 2024
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Publications
Dahlhamer JM, Zammitti EP, Ward BW, Wheaton AG, Croft JB. Prevalence of Inflammatory Bowel Disease Among Adults Aged >/=18 Years - United States, 2015. MMWR Morb Mortal Wkly Rep. 2016 Oct 28;65(42):1166-1169. doi: 10.15585/mmwr.mm6542a3.
PubMed 27787492Singh S, Qian AS, Nguyen NH, Ho SKM, Luo J, Jairath V, Sandborn WJ, Ma C. Trends in U.S. Health Care Spending on Inflammatory Bowel Diseases, 1996-2016. Inflamm Bowel Dis. 2022 Mar 2;28(3):364-372. doi: 10.1093/ibd/izab074.
PubMed 33988697Baumgart DC, Le Berre C. Newer Biologic and Small-Molecule Therapies for Inflammatory Bowel Disease. N Engl J Med. 2021 Sep 30;385(14):1302-1315. doi: 10.1056/NEJMra1907607. No abstract available.
PubMed 34587387Liu JJ, Abraham BP, Adamson P, Barnes EL, Brister KA, Damas OM, Glover SC, Hooks K, Ingram A, Kaplan GG, Loftus EV, McGovern DPB, Narain-Blackwell M, Odufalu FD, Quezada S, Reeves V, Shen B, Stappenbeck TS, Ward L. The Current State of Care for Black and Hispanic Inflammatory Bowel Disease Patients. Inflamm Bowel Dis. 2023 Feb 1;29(2):297-307. doi: 10.1093/ibd/izac124.
PubMed 35816130Afzali A, Cross RK. Racial and Ethnic Minorities with Inflammatory Bowel Disease in the United States: A Systematic Review of Disease Characteristics and Differences. Inflamm Bowel Dis. 2016 Aug;22(8):2023-40. doi: 10.1097/MIB.0000000000000835.
PubMed 27379446Barnes EL, Loftus EV Jr, Kappelman MD. Effects of Race and Ethnicity on Diagnosis and Management of Inflammatory Bowel Diseases. Gastroenterology. 2021 Feb;160(3):677-689. doi: 10.1053/j.gastro.2020.08.064. Epub 2020 Oct 21.
PubMed 33098884Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.
PubMed 15230939Hibbard JH, Greene J. What the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs. Health Aff (Millwood). 2013 Feb;32(2):207-14. doi: 10.1377/hlthaff.2012.1061.
PubMed 23381511Anderson G, Rega ML, Casasanta D, Graffigna G, Damiani G, Barello S. The association between patient activation and healthcare resources utilization: a systematic review and meta-analysis. Public Health. 2022 Sep;210:134-141. doi: 10.1016/j.puhe.2022.06.021. Epub 2022 Aug 12.
PubMed 35970015Barnes EL, Long MD, Kappelman MD, Martin CF, Sandler RS. High Patient Activation Is Associated With Remission in Patients With Inflammatory Bowel Disease. Inflamm Bowel Dis. 2019 Jun 18;25(7):1248-1254. doi: 10.1093/ibd/izy378.
PubMed 30590700Haj O, Lipkin M, Kopylov U, Sigalit S, Magnezi R. Patient activation and its association with health indices among patients with inflammatory bowel disease. Ther Adv Gastroenterol. 2022 Oct 6;15:17562848221128757. doi: 10.1177/17562848221128757. eCollection 2022.
PubMed 36225610
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcomes and Reducing Disparities for Patients With Inflammatory Bowel Disease Through Epidemiology and Enhanced Disease Management (PROMOTE IBD)
- ClinicalTrials.gov ID
- NCT06424769
- Acronym / sponsor ID
- PROMOTE IBD / 24-0699
- Keywords
- Text Messaging, Symptom Monitoring, Social Risk Factors
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Centers for Disease Control and Prevention
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 22 May 2024 (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.
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.
Detailed description
Crohn's 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 one's 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 parent/guardian for pediatric participants), 3) patient reported outcomes for ulcerative colitis and Crohn's 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After completing their baseline survey, consented participants will be randomized to usual care and intervention groups in a 2:1 allocation ratio. A computer-generated, centralized randomization with permuted block randomization within sites to ensure allocation concealment will be utilized.
| Arm | Type | Receives |
|---|---|---|
| Enhanced Digital Care Arm | Active comparator | Other: Enhanced Digital Care, Other: EducationParticipants will receive brief check-in surveys about their IBD symptoms minimally once a month, via text messaging. Participants will also receive IBD educational text messages twice each week. |
| Specialized Education Arm | Placebo comparator | Other: EducationParticipants in this arm will receive IBD educational text messages twice each week. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 13+ years old with IBD (Crohn's disease, ulcerative colitis, indeterminant colitis).
- Followed at a participating site with an office visit (in-person or virtual) within the preceding 12 months.
- Have access to a mobile phone and willing and able to receive and respond to text messages.
- Willing to answer questions on electronic surveys.
- Have the ability to read text messages and answer surveys in English or Spanish.
Key exclusion criteria (2 listed)
- IBD patients s/p surgery with a current pouch or ostomy.
- Unable to provide informed consent and child assent for minors.
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 |
|---|---|---|
| Enhanced Digital CareParticipants will receive brief check-in surveys about their IBD symptoms once a month, via text messaging. If the survey response indicates significant symptoms, an alert will be sent to the participant's IBD care team and participant will receive more frequent surveys (weekly) over the next month. Participants and their IBD clinical team will be able to communicate by text for non-emergency IBD-related questions. | Other | Enhanced Digital Care Arm |
| EducationParticipants will receive education texts about IBD from trusted sources approximately twice a week. Topics will include: diet, medication adherence, fatigue, preventative care and other relevant issues. | Other | Enhanced Digital Care Arm, Specialized Education Arm |
Primary outcome
Change in Patient Activation using PAM
Time frame: Baseline, 12 months
The primary outcome is the change in patient activation from baseline, with a 4-point improvement on Patient Activation Measure (PAM) scale considered a minimal clinically important difference (MCID). Patient activation is an assessment of the knowledge, skills and confidence of patients to manage their health. In chronic diseases, activated patients are more likely to adhere to treatment, perform regular self-monitoring at home and obtain regular chronic care. Activated patients are also more likely to make healthier lifestyle choices and preventative behaviors. Longitudinal improvement in patient activation measures is associated with improved clinical outcomes, decreased unplanned healthcare utilization and lower costs.
3 secondary outcomes
Remission at 52 Weeks
Time frame: 12 months
IBD-Related Quality of Life
Time frame: up to 12 months
Unplanned Healthcare Utilization
Time frame: up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Background: PubMed 27787492Dahlhamer JM, Zammitti EP, Ward BW, Wheaton AG, Croft JB. Prevalence of Inflammatory Bowel Disease Among Adults Aged >/=18 Years - United States, 2015. MMWR Morb Mortal Wkly Rep. 2016 Oct 28;65(42):1166-1169. doi: 10.15585/mmwr.mm6542a3.
- Background: PubMed 33988697Singh S, Qian AS, Nguyen NH, Ho SKM, Luo J, Jairath V, Sandborn WJ, Ma C. Trends in U.S. Health Care Spending on Inflammatory Bowel Diseases, 1996-2016. Inflamm Bowel Dis. 2022 Mar 2;28(3):364-372. doi: 10.1093/ibd/izab074.
- Background: PubMed 34587387Baumgart DC, Le Berre C. Newer Biologic and Small-Molecule Therapies for Inflammatory Bowel Disease. N Engl J Med. 2021 Sep 30;385(14):1302-1315. doi: 10.1056/NEJMra1907607. No abstract available.
- Background: PubMed 35816130Liu JJ, Abraham BP, Adamson P, Barnes EL, Brister KA, Damas OM, Glover SC, Hooks K, Ingram A, Kaplan GG, Loftus EV, McGovern DPB, Narain-Blackwell M, Odufalu FD, Quezada S, Reeves V, Shen B, Stappenbeck TS, Ward L. The Current State of Care for Black and Hispanic Inflammatory Bowel Disease Patients. Inflamm Bowel Dis. 2023 Feb 1;29(2):297-307. doi: 10.1093/ibd/izac124.
- Background: PubMed 27379446Afzali A, Cross RK. Racial and Ethnic Minorities with Inflammatory Bowel Disease in the United States: A Systematic Review of Disease Characteristics and Differences. Inflamm Bowel Dis. 2016 Aug;22(8):2023-40. doi: 10.1097/MIB.0000000000000835.
- Background: PubMed 33098884Barnes EL, Loftus EV Jr, Kappelman MD. Effects of Race and Ethnicity on Diagnosis and Management of Inflammatory Bowel Diseases. Gastroenterology. 2021 Feb;160(3):677-689. doi: 10.1053/j.gastro.2020.08.064. Epub 2020 Oct 21.
- Background: PubMed 15230939Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.
- Background: PubMed 23381511Hibbard JH, Greene J. What the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs. Health Aff (Millwood). 2013 Feb;32(2):207-14. doi: 10.1377/hlthaff.2012.1061.
- Background: PubMed 35970015Anderson G, Rega ML, Casasanta D, Graffigna G, Damiani G, Barello S. The association between patient activation and healthcare resources utilization: a systematic review and meta-analysis. Public Health. 2022 Sep;210:134-141. doi: 10.1016/j.puhe.2022.06.021. Epub 2022 Aug 12.
- Background: PubMed 30590700Barnes EL, Long MD, Kappelman MD, Martin CF, Sandler RS. High Patient Activation Is Associated With Remission in Patients With Inflammatory Bowel Disease. Inflamm Bowel Dis. 2019 Jun 18;25(7):1248-1254. doi: 10.1093/ibd/izy378.
- Background: PubMed 36225610Haj O, Lipkin M, Kopylov U, Sigalit S, Magnezi R. Patient activation and its association with health indices among patients with inflammatory bowel disease. Ther Adv Gastroenterol. 2022 Oct 6;15:17562848221128757. doi: 10.1177/17562848221128757. eCollection 2022.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Michael D Kappelman, MD, MPH principal investigator
University of North Carolina, Chapel Hill
Siddharth Singh, MD principal investigator
Mayo Clinic
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Digital Care and Education in people with Inflammatory Bowel Diseases and Crohn Disease, run by University of North Carolina, Chapel Hill at 9 sites in United States.
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 5 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Activation using PAM (time frame: Baseline, 12 months). 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 NCT06424769, 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 8 Jul 2026.