Adolescent Surgery Roadmap Feasibility and Acceptability Study (Ane-Roadmap)

University of Michigan

Status: Begins enrollment this month

Conditions: Pediatric Surgical Procedures

Treatments: Behavioral: Behavioral Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06991673

HUM00265431

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 12 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Positive Activity Interventions + Surveys

Active Comparator group

Description:

Intervention arm participants will complete one of eight positive activities within the Ane-Roadmap App either as individuals or as an adolescent-caregiver team. Positive activities include gratitude journaling, planning positive experiences, savoring, identifying personal strengths, performing acts of kindness, love letters, engaging with beauty, and positive piggy bank. Participants in the intervention group will receive reminders to complete activities as an individual and as an adolescent-caregiver team. Participants will denote with a checkbox whether intervention activities were completed as an individual vs. as an adolescent-caregiver team. Participants in the control arm will have access to the Ane-Roadmap app, however all intervention activities will be turned off. Both control and intervention groups will complete daily and weekly surveys via links embedded within the Roadmap app. Reminders will be sent to participants to complete surveys each day.

Treatment:

Behavioral: Behavioral Treatment

Surveys Only

No Intervention group

Description:

Control arm participants will not have access to the positive psychology interventions activities within the Ane-Roadmap app. They will only complete daily and weekly surveys.