Patient Automated Text Hovering for IBD

NCT04388865 | Completed

• 1 other identifier: 842733
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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).

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Keywords

Behavioral Economics; Patient Engagement; Remote Monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient Satisfaction

  4 months

• Medication Adherence

  4 months

Study Arms (2)

Control

EXPERIMENTAL

Usual Care

Behavioral: Control

Clinical Hovering

EXPERIMENTAL

Remote monitoring with feedback to social support

Behavioral: Text-based Clinical Hovering

Interventions

Control BEHAVIORAL

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

Control

Text-based Clinical Hovering BEHAVIORAL

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

Clinical Hovering

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Patient Participation

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Shivan Mehta, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 14, 2020
• Study Start: February 23, 2021
• Primary Completion: January 10, 2023
• Study Completion: January 10, 2023
• Last Updated: February 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)