Improving Outcomes and Reducing Disparities for Patients With Inflammatory Bowel Disease Through Epidemiology and Enhanced Disease Management (PROMOTE IBD)

May 16, 2024 updated by: University of North Carolina, Chapel Hill

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92093
        • University of California San Diego
        • Contact:
          • Siddharth Singh, MD, MS
          • Phone Number: 858-246-2544
          • Email: sis040@ucsd.edu
      • San Francisco, California, United States, 94158
        • University of California San Francisco Benioff Children's Hospital
        • Contact:
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30310
        • Morehouse School of Medicine
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
    • New York
      • Lake Success, New York, United States, 11042
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
      • Charlotte, North Carolina, United States, 28203
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • IBD patients s/p surgery with a current pouch or ostomy.
  • Unable to provide informed consent and child assent for minors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Enhanced Digital Care Arm
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.
Other: Enhanced Digital Care
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.
Other: Education
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.
Placebo Comparator: Specialized Education Arm
Participants in this arm will receive IBD educational text messages twice each week.
Other: Education
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission at 52 Weeks
Time Frame: 12 months
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.
12 months
IBD-Related Quality of Life
Time Frame: up to 12 months
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.
up to 12 months
Unplanned Healthcare Utilization
Time Frame: up to 12 months
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).
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

University of Pennsylvania
Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Michael D Kappelman, MD, MPH, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

May 13, 2024

First Submitted That Met QC Criteria

May 16, 2024

First Posted (Actual)

May 22, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 16, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-0699
  • 855107 (Other Identifier: University of Pennsylvania)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

From 9 months after the end of the trial and publication of study results to up to 36 months.

IPD Sharing Access Criteria

Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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