Improving Outcomes and Reducing Disparities for Patients With Inflammatory Bowel Disease Through Epidemiology and Enhanced Disease Management

Conditions

• Colitis
• Crohn Disease
• Inflammatory Bowel Diseases
• Ulcerative Colitis

Eligibility Criteria

Sex

ALL

Age

13 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Enhanced Digital Care — OTHER
  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.
• Education — OTHER
  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 Details

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.

Key Dates

Start date

Jul 24, 2024

Status verified

Oct 2025

Primary completion

Sep 30, 2028

Completion

Sep 30, 2028

Study Design

Enrollment

900 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• 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.
• Placebo Comparator: Specialized Education Arm
  Participants in this arm will receive IBD educational text messages twice each week.

Primary Outcome Measure

Change in Patient Activation using PAM [ Time Frame: Baseline, 12 months ]

Locations (8)

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