Clinical trial NCT05461014: RxWell in Pediatric IBD for Disease Management and Transition Readiness
Official title: Evaluating the Acceptability, Feasibility Utilization of a Digital Behavioral Tool for Adolescents and Young Adults With IBD Who Are in the Process of Transitioning From Pediatric to Adult Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mental Health Issue
Inflammatory Bowel Diseases
Keywords: mobile app
digital behavioral tool
adolescent and young adult
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 7
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the feasibility and acceptability of adapted coached RxWell for patients ages 16-25. Adapt and beta test the modified RxWell product to include chronic disease management and transition readiness. Evaluate RxWell usage and its impact to the TRAQ questionnaire over time.

Detailed description: Baseline TRAQ and PHQ-4 scores will be obtained from the patient as part of routine care during annual visits or as a screening tool after consent to determine eligibility. If the patient is recruited from a visit other than the annual visit, the TRAQ and PHQ4 will be completed to determine eligibility after consent. If eligible, the participant will complete the IBD self-efficacy scale, GAD7, and PHQ8, and will be provided with an access code to download RxWell and will be paired with a UPMC digital health coach who will guide the person through the sessions and text within the app to help give them the tools needed to actively cope with anxiety and/or depression. The adapted version of RxWell includes the same RxWell content/techniques but the coaching model within the adapted version has increased responsibilities of the coach, encouraging the development of necessary transition knowledge and skills for the patient. Coaches in this version will also participate in training about how best to interact with IBD patients regarding their chronic illness, transitions to adult physician, and care management. These coaches will be supervised by a licensed UPMC mental health clinician. The coaches will be informed of the reason for each user's access to the dCBI, TRAQ or PHQ score or both and will interact with the user accordingly. Participants will be asked to complete all study measures (TRAQ, PHQ8, IBD Self-Efficacy, and GAD7) at all time points, baseline, 3 and 6 months.

The user will have access to the app and coach for six months after they have consented. Each technique that is used during those six months will be stored in the practice-again section and available to the participant for use during the study. After six months, participants will no longer have access to the app and will be informed about this change. Participants are informed when they sign up for this app that is not a crisis management tool. There is a risk escalation protocol in place at UPMC if the content of patient's messaging to coaches is alarming.

A randomly selected group of patients who consent to this study and engage with the app, meaning completing 3 or more techniques and/ or actively engaged with the coach, will participate in qualitative interviews to determine how to best implement disease self-management tools within the digital behavioral tool. Every third participant who consents and meets the engagement criteria will be contacted to complete the qualitative interview.

All participants will also be asked to complete quantitative assessments at baseline and again 3 and 6 months later.

Eligibility criteria: Inclusion Criteria:

* Individuals ages 16-25 years with established IBD who are followed in the pediatric gastroenterology clinics at the UPMC Children's Hospital of Pittsburgh
* Patient must be English speaking
* Access to Smartphone
* PHQ-4 score ≥ 5 and/or TRAQ score ≥ 60

Exclusion Criteria:

* Developmental delay

Primary outcomes:
measure: Change in anxiety severity over time
timeFrame: 6 months
measure: Change in depression severity
timeFrame: 6 months
Secondary outcomes:
measure: Change in Transition Readiness to Adult Care
timeFrame: 6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Sandra Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: