Patient Automated Text Hovering for IBD (PATH-IBD)

Clinical Hovering to Improve Patient Engagement in Inflammatory Bowel Disease

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).

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis
• Intervention / Treatment: Behavioral: Control; Behavioral: Text-based Clinical Hovering

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control; Usual Care	Behavioral: Control; Subjects will engage with their providers as is standard of care.
Experimental: Clinical Hovering; Remote monitoring with feedback to social support	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) response	The change in patient response to the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), which is a 10 question validated instrument to measure quality of life in IBD patients.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	Patient satisfaction, adapted from the CACHE questionnaire, will be measured by the percent who agree/totally agree (scored as 1 or 2 on a scale of 1-5) to each survey question. A net promoter score (scored as percent 9 or 10 minus percent 1-6 on a scale of 1-10) will also be calculated for the intervention group only.	4 months
Medication Adherence	Medication adherence will be measured as show rate for infusions and percent dispensed by pharmacy for injectables based on chart review at pre- and post-intervention, along with the change in percent reported adherence at the baseline and post-study survey.	4 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2021
• Primary Completion (Actual): January 10, 2023
• Study Completion (Actual): January 10, 2023

Study Registration Dates

• First Submitted: May 7, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 14, 2020

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Remote Monitoring; Patient Engagement; Behavioral Economics
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases
• Other Study ID Numbers: 842733

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No