Patient Automated Text Hovering for IBD

NCT ID: NCT04388865

Last Updated: 2023-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-23
• Study Completion Date: 2023-01-10

Brief Summary

This is a 2-arm randomized trial aimed at leveraging behavioral science principles to improve patient engagement between office visits among patients with inflammatory bowel disease (IBD).

Detailed Description

Crohn's Disease (CD) and Ulcerative Colitis (UC), collectively known as inflammatory bowel disease (IBD), are common chronic gastrointestinal diseases with significant morbidity and decreased quality of life. Care for patients with IBD has been transformed by biologic therapies which dramatically improve inflammation and clinical outcomes. As they are delivered through infusion or injection with long intervals between doses, it can be challenging for patients to maintain adherence due to systems issues such as prior authorization and site of service limitations, in addition to traditional reasons for non-adherence such as inertia and present-time bias. Despite evidence that high adherence is needed for effectiveness, estimates are as low as 66%.

Preliminary observations and interviews show that an important gap for providers is lack of knowledge of how their patients are doing between visits. Specifically, patients may not adhere to necessary therapy, and physicians are unaware of changes in course of the disease. A large cross-sectional study has shown that patient-reported outcomes are associated with control of the disease, but serially monitoring these measures has not been tested prospectively. A prior study found that assessing symptoms weekly is highly correlated with information collected with a more cumbersome daily diary. This may provide additional data to clinicians to better manage symptoms and therapy.

Text messaging is an attractive tool to engage with patients due to the high prevalence of cell phones. The investigators will develop and test a new IBD hovering program that improves the care of patients between office visits. The investigators will enroll patients prescribed biologic therapy and provide text message reminders about scheduled infusions or injections that incorporate behavioral science principles such as anticipated regret, precommitment, and reciprocity. The investigators will also have the patient identify a friend or family member to serve as a support partner to encourage adherence and provide assistance as needed. The platform will communicate with patients weekly to ask about the course of their symptoms, send messaging to the feedback partner, and send alerts to physicians as needed.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Control

Usual Care

Group Type: EXPERIMENTAL

Control

Intervention Type: BEHAVIORAL

Subjects will engage with their providers as is standard of care.

Clinical Hovering

Remote monitoring with feedback to social support

Group Type: EXPERIMENTAL

Text-based Clinical Hovering

Intervention Type: BEHAVIORAL

Subjects will receive remote monitoring via text messaging of clinical symptoms and medication adherence reminders with feedback to social support.

Interventions

Control

Subjects will engage with their providers as is standard of care.

Intervention Type: BEHAVIORAL

Text-based Clinical Hovering

Subjects will receive remote monitoring via text messaging of clinical symptoms and medication adherence reminders with feedback to social support.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosis of Crohn's Disease or Ulcerative Colitis
• Has had at least 2 visits with Penn Gastroenterology in the past 2 years
• Currently prescribed a biologic therapy (infliximab, adalimumab, ustekinumab, certolizumab, golimumab, or vedolizumab). Of note, this study is not limited to new initiators of these medications.

Exclusion Criteria

• Patients will be excluded if they do not have a phone with text messaging.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Shivan J Mehta

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shivan Mehta, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

842733

Identifier Type: -

Identifier Source: org_study_id