Status:
NOT_YET_RECRUITING
Adolescent Surgery Roadmap Feasibility and Acceptability Study
Lead Sponsor:
University of Michigan
Conditions:
Pediatric Surgical Procedures
Eligibility:
All Genders
12-99 years
Phase:
NA
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 th...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06991673
Start Date
July 1 2025
End Date
December 1 2029
Last Update
June 5 2025
Active Locations (3)
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1
Michigan Medicine- East Ann Arbor Ambulatory Surgery and Medical Procedures Center
Ann Arbor, Michigan, United States, 48109
2
University of Michigan affiliated hospitals
Ann Arbor, Michigan, United States, 48109
3
Michigan Medicine- Brighton Center for Specialty Care
Brighton, Michigan, United States, 48116