Patient Automated Text Hovering for IBD

Ulcerative Colitis Clinical Trial

— PATH-IBD  

Official title:

Clinical Hovering to Improve Patient Engagement in Inflammatory Bowel Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04388865
• Other study ID #: 842733
• Status: Completed
• Phase: N/A
• Start date: February 23, 2021
• Est. completion date: January 10, 2023

Study information

• Verified date: February 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 10, 2023
• Est. primary completion date: January 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Control
Subjects will engage with their providers as is standard of care.
• Text-based Clinical Hovering
Subjects will receive remote monitoring via text messaging of clinical symptoms and medication adherence reminders with feedback to social support.

Locations

Country	Name	City	State
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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