Inflammatory Bowel DiseasesNCT06186752
Feasibility Test of Action Planning in Pediatric IBD
A study testing MyIBD in people with Inflammatory Bowel Diseases, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The goal of this interventional study is to test the feasibility of a new communication tool, call MyIBD, in youth ages 13 to 19 years with inflammatory bowel disease. The main question[s] it aims to answer are: Is the MyIBD communication tool feasible to use in everyday clinical practice? Does the MyIBD tool have… Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- MyIBD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2024to 5 Apr 2026
- 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 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 13-19 years old at time of recruitment; AND
- diagnosis at least 3 months earlier of Crohn's disease, ulcerative colitis, or indeterminate colitis (to exclude families who have not had sufficient time to become familiar with condition and/or clinic personnel); AND
- receiving ongoing care at UNC (at least one visit in the past year)
Who cannot join
- speaker of a language other than English or Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina-Chapel Hill School of Medicine
Chapel Hill, North Carolina, 27599
About this study
Official title: Feasibility of a Care Team-Focused Action Plan to Improve Quality of Care for Children and Adolescents With Inflammatory Bowel Disease
The goal of this interventional study is to test the feasibility of a new communication tool, call MyIBD, in youth ages 13 to 19 years with inflammatory bowel disease. The main question[s] it aims to answer are:
- Is the MyIBD communication tool feasible to use in everyday clinical practice?
- Does the MyIBD tool have potential to improve patients' self-management skills and the quality of care they receive?
Read more
Participants who receive the MyIBD intervention will complete surveys about their care at three times points - at study enrollment, at 6 months, and at 12 months. The surveys will help the research team learn about the feasibility of using MyIBD in practice and about any effects on patients' self-management skills and quality of care.
Researchers will compare those receiving a MyIBD document to a randomly selected control group (patients receiving usual care for pediatric inflammatory bowel disease) to see if self-management skills and quality of care differ between the groups.
Read the detailed description
Quality of care for youth with chronic disease suffers because of gaps in care coordination and communication among patients/families and multiple health care providers. As youth with inflammatory bowel disease (IBD) have preventive and acute care needs beyond those of peers, IBD provides an excellent use case to evaluate interventions to enhance coordination and improve quality. Electronic health records (EHRs) have unfulfilled potential to facilitate coordination and effective action among teams of providers and families. This project leverages web-based and mobile phone application access points to share patient-specific information from an IBD center's EHR. The intervention, MyIBD, has been developed with systematic input from patients, families, and providers. Our objective is to assess the feasibility of delivering tailored guidance on IBD-related health needs to families and care team members using a low-cost, low-risk health communication innovation using existing health information technology. The rationale is that brief, actionable, individually tailored guidance from IBD specialists to families and other providers will support decisions about seeking and providing timely preventive and acute care. Though the intervention builds on prior work and evidence and has been pilot tested, it requires feasibility testing in practice prior to large-scale evaluation. We will assess feasibility of MyIBD through a pilot randomized, controlled trial at one site (n=60). The study has three research aims: (1) assess the feasibility of a rollout effectiveness trial design; (2) assess the feasibility and acceptability of implementing MyIBD in a pediatric IBD clinic; (3) explore the feasibility of MyIBD to improve (a) care quality measures collected from participants and the EHR and (b) patient self-management. In Aim 1 we will assess subject recruitment, randomization, retention, intervention completion, and contamination of control subjects using a study log. For Aim 2 we will use interviews (will take place after completion of the feasibility trial) and surveys to learn about barriers and facilitators of adoption by IBD clinics and acceptability and appropriateness from the perspectives of patients/families and care providers. For Aim 3 we will use surveys and medical record data to explore change over time in family-reported care quality, patient self-management, and completion of guideline-supported quality indicators for pediatric IBD for intervention and control groups. This project is innovative in seeking to change the default ways that care team members share information and address shared responsibilities. MyIBD targets well-described barriers to coordination and incorporates behavioral strategies of individual tailoring, family participation, expert modeling, and facilitation to streamline information delivery and enhance its relevance, accessibility, and actionability. The proposed study is significant because of its potential to improve health through a low-cost intervention to enhance use of existing health information technology. The study's findings could provide a framework for EHR-supported quality improvements through learning health system research across a range of childhood-onset chronic diseases.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- MyIBD
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyIBDBehavioural
MyIBD has two components: (1) an electronic, templated document that presents brief, actionable, tailored guidance from IBD specialists to families and other providers who care for a pediatric patient with IBD; and (2) regular, short prompts sent through the electronic patient portal to remind patients to refer to and use their MyIBD document to guide decisions about care in between appointments.
| Study group | Role | What they receive |
|---|---|---|
| MyIBD | Experimental | Each participant randomized to the intervention arm (MyIBD) will receive an individually tailored MyIBD document within a week of a scheduled outpatient clinic visit. The MyIBD document will be prepared by the patient's usual, assigned nurse coordinator together with the study's clinical champion (a nurse practitioner in the IBD program). Participants will receive a copy of the MyIBD document with language suggesting that they use it to guide decisions about care in between appointments. Each participant's primary care provider will also receive a copy of the MyIBD document. The nurse coordinator will send reminder messages to intervention-group participants (using the electronic patient portal) to access and use their MyIBD document at 1-2 months, 3-4 months, 7-8 months, and 11-12 months after initial plan creation. Receives: Behavioral: MyIBD |
| Usual Care | No intervention | Each participant randomized to the control group will receive usual care in the pediatric IBD program. They will be eligible to receive a MyIBD document after completing the study (12 months after enrollment). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of overall participants recruited and randomized
Number (0-60) will be an indicator of feasibility of implementing MyIBD in practice.
Measured: Measured and reported at the end of study year 1
Number of intervention group participants who receive a MyIBD document
Number (0-30) of intervention-group participants who receive a MyIBD document will estimate the degree of completion of the intervention in practice.
Measured: Measured and reported at the end of study year 1
Number of overall participants retained through baseline survey
Number (0-60) of participants who complete the baseline survey
Measured: Measured and reported at the end of study year 1
Number of overall participants retained through 6-month survey
Number (0-60) of participants who complete the 6-month survey
Measured: Measured and reported at the mid-point of study year 2
Number of overall participants retained through 12-month survey
Number (0-60) of participants who complete the 12-month survey
Measured: Measured and reported at end of study year 2
Number of control group participants who receive a MyIBD document
Number (0-30) of control-group participants who (inappropriately) receive a MyIBD document is an indicator of contamination, or spreading the intervention in practice to the control group.
Measured: Measured and reported at the end of study year 1
Number of intervention group participants who agree or completely agree that MyIBD is an acceptable intervention using the Acceptability of Intervention Measure
Measured in the 12-month participant survey using the Acceptability of Intervention Measure (AIM), a four-item scale with five Likert-type response options from 1=Completely disagree to 5=Completely agree. Item scores are averaged to yield a scale score, with 1 indicating the lowest level of acceptability and 5 indicating the highest level.
Measured: Reported at the end of study year 2
Number of intervention group participants who agree or completely agree that MyIBD is an appropriate intervention using the Intervention Appropriateness Measure
Measured in the 12-month participant survey using the Intervention Appropriateness Measure (IAM), a four-item scale with five Likert-type response options from 1=Completely disagree to 5=Completely agree. Item scores are averaged to yield a scale score, with 1 indicating the lowest level of appropriateness and 5 indicating the highest level.
Measured: Reported at the end of study year 2
Secondary outcomes (5)
Mean self-management score on the Partners in Health scale at baseline
Measured in the baseline participant survey using the Partners in Health Scale, a 12-item survey with 9 Likert-type response options from 0=Very Little/Never to 8=A Lot/Always. Item scores are summed to yield a total scale score from 0, indicating the lowest level of self-management skill, to 96, indicating the highest level of self-management skill.
Measured: Measured in each participant's baseline survey; reported at end of study year 1
Mean self-management score on the Partners in Health scale at 6 months
Measured in the 6-month participant survey using the Partners in Health Scale, a 12-item survey with 9 Likert-type response options from 0=Very Little/Never to 8=A Lot/Always. Item scores are summed to yield a total scale score from 0, indicating the lowest level of self-management skill, to 96, indicating the highest level of self-management skill.
Measured: Measured in each participant's 6-month survey; reported at end of study year 2
Mean self-management score on the Partners in Health scale at 12 months
Measured in the 12-month participant survey using the Partners in Health Scale, a 12-item survey with 9 Likert-type response options from 0=Very Little/Never to 8=A Lot/Always. Item scores are summed to yield a total scale score from 0, indicating the lowest level of self-management skill, to 96, indicating the highest level of self-management skill.
Measured: Measured in each participant's 12-month survey; reported at end of study year 2
Mean perceived Quality of Care score at baseline using the Patient Assessment of Chronic Illness Care survey
Measured in the baseline participant survey using the Patient Assessment of Chronic Illness Care scale, a 20-item survey with 5 Likert-type responses from 1=None of the time to 5=Always. Item scores are averaged to yield an overall scale score between 1 and 5, with 1 indicating the lowest perceived care quality and 5 indicating the highest.
Measured: Measured in each participant's baseline survey; reported at end of study year 1
Mean perceived Quality of Care score at 12 months using the Patient Assessment of Chronic Illness Care survey
Measured in the 12-month participant survey using the Patient Assessment of Chronic Illness Care scale, a 20-item survey with 5 Likert-type responses from 1=None of the time to 5=Always. Item scores are averaged to yield an overall scale score between 1 and 5, with 1 indicating the lowest perceived care quality and 5 indicating the highest.
Measured: Measured in each participant's 12-month survey; reported at end of study year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start5 Feb 2024
- Primary completion1 Mar 2026
- Study completion5 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized 1:1 overall to intervention and control using permuted blocks (four) designed according to each alphabetic cluster's assigned nurse coordinator.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Neal deJong, MD, Principal investigator, UNC-Chapel Hill School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186752
- Sponsor's protocol ID
- 23-2704
- Other IDs
- R03TR004311-01A1
- Status last verified
- Oct 2026
- First submitted
- 15 Dec 2023
- Last updated
- 29 Oct 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Care Team-Focused Action Plan to Improve Quality of Care for Children and Adolescents With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT06186752
- Acronym / sponsor ID
- 23-2704
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 5 Apr 2026 (actual)
- First posted
- 2 Jan 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 interventional study is to test the feasibility of a new communication tool, call MyIBD, in youth ages 13 to 19 years with inflammatory bowel disease. The main question[s] it aims to answer are:
- Is the MyIBD communication tool feasible to use in everyday clinical practice?
- Does the MyIBD tool have potential to improve patients' self-management skills and the quality of care they receive?
Participants who receive the MyIBD intervention will complete surveys about their care at three times points - at study enrollment, at 6 months, and at 12 months. The surveys will help the research team learn about the feasibility of using MyIBD in practice and about any effects on patients' self-management skills and quality of care.
Researchers will compare those receiving a MyIBD document to a randomly selected control group (patients receiving usual care for pediatric inflammatory bowel disease) to see if self-management skills and quality of care differ between the groups.
Detailed description
Quality of care for youth with chronic disease suffers because of gaps in care coordination and communication among patients/families and multiple health care providers. As youth with inflammatory bowel disease (IBD) have preventive and acute care needs beyond those of peers, IBD provides an excellent use case to evaluate interventions to enhance coordination and improve quality. Electronic health records (EHRs) have unfulfilled potential to facilitate coordination and effective action among teams of providers and families. This project leverages web-based and mobile phone application access points to share patient-specific information from an IBD center's EHR. The intervention, MyIBD, has been developed with systematic input from patients, families, and providers. Our objective is to assess the feasibility of delivering tailored guidance on IBD-related health needs to families and care team members using a low-cost, low-risk health communication innovation using existing health information technology. The rationale is that brief, actionable, individually tailored guidance from IBD specialists to families and other providers will support decisions about seeking and providing timely preventive and acute care. Though the intervention builds on prior work and evidence and has been pilot tested, it requires feasibility testing in practice prior to large-scale evaluation. We will assess feasibility of MyIBD through a pilot randomized, controlled trial at one site (n=60). The study has three research aims: (1) assess the feasibility of a rollout effectiveness trial design; (2) assess the feasibility and acceptability of implementing MyIBD in a pediatric IBD clinic; (3) explore the feasibility of MyIBD to improve (a) care quality measures collected from participants and the EHR and (b) patient self-management. In Aim 1 we will assess subject recruitment, randomization, retention, intervention completion, and contamination of control subjects using a study log. For Aim 2 we will use interviews (will take place after completion of the feasibility trial) and surveys to learn about barriers and facilitators of adoption by IBD clinics and acceptability and appropriateness from the perspectives of patients/families and care providers. For Aim 3 we will use surveys and medical record data to explore change over time in family-reported care quality, patient self-management, and completion of guideline-supported quality indicators for pediatric IBD for intervention and control groups. This project is innovative in seeking to change the default ways that care team members share information and address shared responsibilities. MyIBD targets well-described barriers to coordination and incorporates behavioral strategies of individual tailoring, family participation, expert modeling, and facilitation to streamline information delivery and enhance its relevance, accessibility, and actionability. The proposed study is significant because of its potential to improve health through a low-cost intervention to enhance use of existing health information technology. The study's findings could provide a framework for EHR-supported quality improvements through learning health system research across a range of childhood-onset chronic diseases.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized 1:1 overall to intervention and control using permuted blocks (four) designed according to each alphabetic cluster's assigned nurse coordinator.
| Arm | Type | Receives |
|---|---|---|
| MyIBD | Experimental | Behavioral: MyIBDEach participant randomized to the intervention arm (MyIBD) will receive an individually tailored MyIBD document within a week of a scheduled outpatient clinic visit. The MyIBD document will be prepared by the patient's usual, assigned nurse coordinator together with the study's clinical champion (a nurse practitioner in the IBD program). Participants will receive a copy of the MyIBD document with language suggesting that they use it to guide decisions about care in between appointments. Each participant's primary care provider will also receive a copy of the MyIBD document. The nurse coordinator will send reminder messages to intervention-group participants (using the electronic patient portal) to access and use their MyIBD document at 1-2 months, 3-4 months, 7-8 months, and 11-12 months after initial plan creation. |
| Usual Care | No intervention | –Each participant randomized to the control group will receive usual care in the pediatric IBD program. They will be eligible to receive a MyIBD document after completing the study (12 months after enrollment). |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- age 13-19 years old at time of recruitment; AND
- diagnosis at least 3 months earlier of Crohn's disease, ulcerative colitis, or indeterminate colitis (to exclude families who have not had sufficient time to become familiar with condition and/or clinic personnel); AND
- receiving ongoing care at UNC (at least one visit in the past year)
Key exclusion criteria (1 listed)
- speaker of a language other than English or Spanish
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 |
|---|---|---|
| MyIBDMyIBD has two components: (1) an electronic, templated document that presents brief, actionable, tailored guidance from IBD specialists to families and other providers who care for a pediatric patient with IBD; and (2) regular, short prompts sent through the electronic patient portal to remind patients to refer to and use their MyIBD document to guide decisions about care in between appointments. | Behavioural | MyIBD |
Primary outcome
Number of overall participants recruited and randomized
Time frame: Measured and reported at the end of study year 1
Number (0-60) will be an indicator of feasibility of implementing MyIBD in practice.
Number of intervention group participants who receive a MyIBD document
Time frame: Measured and reported at the end of study year 1
Number (0-30) of intervention-group participants who receive a MyIBD document will estimate the degree of completion of the intervention in practice.
Number of overall participants retained through baseline survey
Time frame: Measured and reported at the end of study year 1
Number (0-60) of participants who complete the baseline survey
Number of overall participants retained through 6-month survey
Time frame: Measured and reported at the mid-point of study year 2
Number (0-60) of participants who complete the 6-month survey
Number of overall participants retained through 12-month survey
Time frame: Measured and reported at end of study year 2
Number (0-60) of participants who complete the 12-month survey
Number of control group participants who receive a MyIBD document
Time frame: Measured and reported at the end of study year 1
Number (0-30) of control-group participants who (inappropriately) receive a MyIBD document is an indicator of contamination, or spreading the intervention in practice to the control group.
Number of intervention group participants who agree or completely agree that MyIBD is an acceptable intervention using the Acceptability of Intervention Measure
Time frame: Reported at the end of study year 2
Measured in the 12-month participant survey using the Acceptability of Intervention Measure (AIM), a four-item scale with five Likert-type response options from 1=Completely disagree to 5=Completely agree. Item scores are averaged to yield a scale score, with 1 indicating the lowest level of acceptability and 5 indicating the highest level.
Number of intervention group participants who agree or completely agree that MyIBD is an appropriate intervention using the Intervention Appropriateness Measure
Time frame: Reported at the end of study year 2
Measured in the 12-month participant survey using the Intervention Appropriateness Measure (IAM), a four-item scale with five Likert-type response options from 1=Completely disagree to 5=Completely agree. Item scores are averaged to yield a scale score, with 1 indicating the lowest level of appropriateness and 5 indicating the highest level.
5 secondary outcomes
Mean self-management score on the Partners in Health scale at baseline
Time frame: Measured in each participant's baseline survey; reported at end of study year 1
Mean self-management score on the Partners in Health scale at 6 months
Time frame: Measured in each participant's 6-month survey; reported at end of study year 2
Mean self-management score on the Partners in Health scale at 12 months
Time frame: Measured in each participant's 12-month survey; reported at end of study year 2
Mean perceived Quality of Care score at baseline using the Patient Assessment of Chronic Illness Care survey
Time frame: Measured in each participant's baseline survey; reported at end of study year 1
Mean perceived Quality of Care score at 12 months using the Patient Assessment of Chronic Illness Care survey
Time frame: Measured in each participant's 12-month survey; reported at end of study year 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- 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.
Related trials for Inflammatory Bowel Diseases
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Effect of Mediterranean Diet in Inflammatory Bowel Disease
Inflammatory Bowel Disease
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.
Neal deJong, MD principal investigator
UNC-Chapel Hill School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyIBD in people with Inflammatory Bowel Diseases, run by University of North Carolina, Chapel Hill at 1 site 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 29 Oct 2026. 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 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of overall participants recruited and randomized (time frame: Measured and reported at the end of study year 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2026.