Adolescent Surgery Roadmap Feasibility and Acceptability Study

N/ANot Yet RecruitingNCT06991673

University of Michigan100 enrolled

Overview

The goal of this clinical trial is to test the feasibility and acceptability of using a mobile health app, Ane-Roadmap, designed to support adolescents (ages 12-17) undergoing painful surgeries and their caregivers. The main questions it aims to answer are: * Can adolescent surgery patients and their caregivers be successfully enrolled in the study, with at least 40% of those invited choosing to participate? * Will participants actively use the mobile app, completing at least two activities per week for at least half of the study period, either individually and/or as a caregiver-adolescent pair? Participants will: * Use the Ane-Roadmap app during their post-surgery recovery period to complete resilience-building activities aimed at improving wellbeing * Use the app either individually or together as a caregiver-adolescent pair. * Complete surveys regarding risk factors for adverse postsurgical pain outcomes and physical and psychological symptoms experienced postoperatively * Some participants will complete a semi-structured interview in which experiences with the study and intervention activities will be elicited

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

100

Conditions

Pediatric Surgical Procedures

Interventions

Eligibility

Sex: ALLMin age: 12 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria (Adolescent Patient): * Patient is aged 12-17 years on the date of surgery * Surgery is a scheduled surgery (non-emergency) * Surgery is occurring within the University of Michigan hospital system (University Hospital, C.S. Mott Children's Hospital, Brighton Ambulatory Surgery Center, East Ann Arbor Ambulatory Surgery Center) * Participants are able to enroll within 1-2 weeks of surgery * Patient and caregiver must be willing to participate * Adolescent and caregiver must have a compatible smartphone and/or tablet with internet access and be willing to download an app * Eligible patient is able to sign/assent form * Adolescent-caregiver dyad has at least one risk factor for adverse post-operative pain outcomes based on pre-enrollment screening (e.g., worries about managing pain, return to normal activities, limitations in doing desired activities, trouble with sleep) Inclusion Criteria (Caregiver): * Patient and caregiver must be willing to participate * Caregiver must be providing at least 50% of the patient's postsurgical caregiving * Caregivers agree to provide informed consent that is in regulatory compliance and IRBMED-approved and also in accordance with institutional guidelines * Adolescent and caregiver must have a compatible smartphone and/or tablet with internet access and be willing to download an app Exclusion Criteria (Adolescent Patient): * Adolescent or caregiver are unable to complete intervention activities or surveys in spoken or written English * Significant developmental delay, making it impossible for the participant to use an app to complete interventions or answer survey questions * Foster children or wards of the state are not eligible for inclusion * Hardware removal or debridement surgery (not considered as painful as other orthopedic surgeries) * Scoliosis surgery (due to extended longitudinal relationship with surgeon) * Concurrent participation in another behavioral/self-management intervention trial * Any impairment, activity, or situation that in the judgment of the Study Coordinator or Principal would make it inappropriate for the subject to participate Exclusion Criteria (Caregiver): * Significant developmental delay, making it impossible for the participant to use an app to complete interventions or answer survey questions * Adolescent or caregiver are unable to complete intervention activities or surveys in spoken or written English * Any impairment, activity, or situation that in the judgment of the Study Coordinator or Principal would make it inappropriate for the subject to participate

Outcomes

Primary Outcomes

Recruitment Potential (Feasibility)

The percent of eligible dyads willing to enroll (N subjects enrolled / N subjects successfully reached). This information will be derived from recruitment data. The threshold for success is that 40% of eligible dyads enroll.