Clinical trial NCT06991673: Adolescent Surgery Roadmap Feasibility and Acceptability Study
Official title: Adolescent Surgery Roadmap Feasibility and Acceptability Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pediatric Surgical Procedures
Keywords: positive psychology
mobile health
surgical recovery
adolescent
caregiver
pediatric surgery
mobile health intervention
positive psychology intervention
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment Potential (Feasibility)
timeFrame: Up to 74 days (60 days post-surgery)
measure: Module Engagement (Feasibility)
timeFrame: Up to 74 days (60 days post-surgery)
measure: Module Engagement (Feasibility)
timeFrame: Up to 74 days (60 days post-surgery)
Secondary outcomes:
measure: Adolescent Global Health
timeFrame: Up to 74 days (60 days post-surgery)
measure: Caregiver Global Health
timeFrame: Up to 74 days (60 days post-surgery)
measure: Adolescent pain intensity
timeFrame: Up to 74 days (60 days post-surgery)
measure: Adolescent Pain Interference
timeFrame: Up to 74 days (60 days post-surgery)
measure: Adolescent Mood
timeFrame: Up to 74 days (60 days post-surgery)
measure: Adolescent anxiety
timeFrame: Up to 74 days (60 days post-surgery)
measure: Caregiver anxiety
timeFrame: Up to 74 days (60 days post-surgery)
measure: Caregiver mood
timeFrame: Up to 74 days (60 days post-surgery)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Medicine- East Ann Arbor Ambulatory Surgery and Medical Procedures Center
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan affiliated hospitals
state: Michigan
city: Brighton
country: United States
facility: Michigan Medicine- Brighton Center for Specialty Care
state: Michigan
Study officials:
affiliation: University of Michigan
name: Sydney Brown, MD PhD
role: PRINCIPAL_INVESTIGATOR
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