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NCT Number: NCT06991673

Adolescent Surgery Roadmap Feasibility and Acceptability Study

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

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Key information

Conditions

Pediatric Surgical Procedures

Age range

12 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral Treatment

Behavioral

Positive Activity Interventions within Ane-Roadmap App

Positive Piggy Bank - Capture happy moments by mentally savoring them, recording details, and depositing them into a "piggy bank". Open it when you need a boost.

Gratitude Diary - Write two unique things daily for which you're grateful. Smile as you record them to enhance gratitude.

Savoring - Each day, spend 2-3 minutes fully enjoying two positive experiences. Log them for reflection.

Pleasant Activity Scheduling - Plan and engage in enjoyable activities at least twice weekly. Treat them as important appointments.

Random Acts of Kindness - Perform five intentional kind acts in a day, four for others and one for yourself.

Signature Strengths - Use a personal strength in a new way daily and reflect on its impact.

Love Letter - Express deep appreciation to a loved one in a heartfelt letter and share it with them.

Engaging with Beauty - Keep a log of beautiful moments in nature, art, or human kindness.

Other names: Positive Activity Exercises

Primary outcomes

  1. Recruitment Potential (Feasibility)

    Time frame: 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.

  2. Module Engagement (Feasibility)

    Time frame: Up to 74 days (60 days post-surgery)

    The number of days each week a Roadmap intervention module is used each week. This will be derived from app usage data. Threshold for success: Completion of any intervention module at least twice weekly for 70% of the study weeks as an individual or adolescent-caregiver team.

  3. Module Engagement (Feasibility)

    Time frame: 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 outcomes

  1. Adolescent Global Health

    Time frame: 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.

  2. Caregiver Global Health

    Time frame: 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.

  3. Adolescent pain intensity

    Time frame: 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.

  4. Adolescent Pain Interference

    Time frame: 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.

  5. Adolescent Mood

    Time frame: 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.

  6. Adolescent anxiety

    Time frame: 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.

  7. Caregiver anxiety

    Time frame: 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.

  8. Caregiver mood

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Wymer, BA

CONTACT

[email protected]

734-998-4551

Sydney Brown, MD PhD

CONTACT

[email protected]

734-803-3152

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Acronym: Ane-Roadmap

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
May 28, 2025
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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