Adolescent Surgery Roadmap Feasibility and Acceptability Study

Not Applicable

Not yet recruiting

• Conditions: Pediatric Surgical Procedures

• Registration Number: NCT06991673
• Lead Sponsor: University of Michigan

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-16
• Study First Submitted QC: 2025-05-16
• Study First Posted: 2025-05-28
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-02
• Last Update Posted: 2025-06-05
• Study Start: 2025-07
• Primary Completion: 2029-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recruitment Potential (Feasibility)	Up to 74 days (60 days post-surgery)	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.
Module Engagement (Feasibility)	Up to 74 days (60 days post-surgery)	The number of days each week a Roadmap intervention module is used as an adolescent-caregiver team each week. This will be derived from app usage data. Threshold for success: 2) 50% of participants will complete Roadmap intervention activities as a team at least one time for 50% of the study weeks.

Secondary Outcome Measures

Name	Time	Method
Adolescent Global Health	Up to 74 days (60 days post-surgery)	Adolescent Global Health, assessed by Patient-Reported Outcomes Measurement Information System Pediatric Profile-25 (Minimum value: 12, Maximum value: 120). Higher scores on positive domains (Physical Function and Peer Relationships) = Better outcome. Higher scores on negative domains (Anxiety, Depressive Symptoms, Fatigue, Pain Interference, Pain Intensity) = Worse outcome.
Caregiver Global Health	Up to 74 days (60 days post-surgery)	Caregiver Global Health assessed using Patient-Reported Outcomes Measurement Information System 29+2 Profile Version 2.1 (Minimum score: 16, Maximum score 160). Higher scores on positive domains (Physical Function, Ability to Participate in Social Roles and Activities) = Better outcome. Higher scores on negative domains (Anxiety, Depression, Fatigue, Pain Interference, Sleep Disturbance, Pain Intensity) = Worse outcome.
Adolescent pain intensity	Up to 74 days (60 days post-surgery)	Adolescent pain intensity, assessed using Patient-Reported Outcomes Measurement Information System Pediatric Pain Intensity (Minimum value: 0, Maximum value: 10). Higher scores indicate a worse outcome, representing greater pain intensity.
Adolescent Pain Interference	Up to 74 days (60 days post-surgery)	Adolescent pain interference, assessed using Patient-Reported Outcomes Measurement Information System Pediatric Pain Interference Short Form 8a (Minimum value: 0, Maximum value: 10). Higher scores indicate a worse outcome, representing greater interference of pain with daily activities and functioning.
Adolescent Mood	Up to 74 days (60 days post-surgery)	Adolescent mood, assessed using Patient-Reported Outcomes Measurement Information System Pediatric Depressive Symptoms - Mood Subscale (minimum value: 4, Maximum value: 20). Higher scores indicate a worse outcome, representing greater depressive symptoms.
Adolescent anxiety	Up to 74 days (60 days post-surgery)	Adolescent anxiety, assessed using Patient-Reported Outcomes Measurement Information System Pediatric Anxiety - Anxiety Subscale (Minimum value: 4, Maximum value: 20). Higher scores indicate a worse outcome, reflecting greater anxiety symptoms.
Caregiver anxiety	Up to 74 days (60 days post-surgery)	Caregiver anxiety, assessed using Patient-Reported Outcomes Measurement Information System Anxiety Subscale (Minimum value: 4, Maximum value: 20). Higher scores indicate a worse outcome, reflecting greater anxiety symptoms.
Caregiver mood	Up to 74 days (60 days post-surgery)	Caregiver mood, assessed using Patient-Reported Outcomes Measurement Information System Mood Subscale (Minimum value: 4, Maximum value: 20). Higher scores indicate a worse outcome, reflecting greater negative mood symptoms.

Trial Locations

Locations (3)

Michigan Medicine- East Ann Arbor Ambulatory Surgery and Medical Procedures Center; 🇺🇸 Ann Arbor, Michigan, United States

University of Michigan affiliated hospitals; 🇺🇸 Ann Arbor, Michigan, United States

Michigan Medicine- Brighton Center for Specialty Care; 🇺🇸 Brighton, Michigan, United States