Patient Automated Text Hovering for IBD (PATH-IBD)
Primary Purpose
Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control
Text-based Clinical Hovering
Sponsored by
About this trial
This is an interventional health services research trial for Inflammatory Bowel Diseases focused on measuring Behavioral Economics, Patient Engagement, Remote Monitoring
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.
Sites / Locations
- University of Pennsylvania Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Control
Clinical Hovering
Arm Description
Usual Care
Remote monitoring with feedback to social support
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04388865
First Posted
May 7, 2020
Last Updated
February 21, 2023
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT04388865
Brief Title
Patient Automated Text Hovering for IBD
Acronym
PATH-IBD
Official Title
Clinical Hovering to Improve Patient Engagement in Inflammatory Bowel Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 23, 2021 (Actual)
Primary Completion Date
January 10, 2023 (Actual)
Study Completion Date
January 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
Keywords
Behavioral Economics, Patient Engagement, Remote Monitoring
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Experimental
Arm Description
Usual Care
Arm Title
Clinical Hovering
Arm Type
Experimental
Arm Description
Remote monitoring with feedback to social support
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Subjects will engage with their providers as is standard of care.
Intervention Type
Behavioral
Intervention Name(s)
Text-based Clinical Hovering
Intervention Description
Subjects will receive remote monitoring via text messaging of clinical symptoms and medication adherence reminders with feedback to social support.
Primary Outcome Measure Information:
Title
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) response
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Description
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.
Time Frame
4 months
Title
Medication Adherence
Description
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.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shivan Mehta, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Patient Automated Text Hovering for IBD
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