Adolescent Surgery Roadmap Feasibility and Acceptability Study

NCT06991673 | Not Yet Recruiting DMC

• 1 other identifier: HUM00265431
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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

Conditions

Pediatric Surgical Procedures

Keywords

positive psychology; mobile health; surgical recovery; adolescent; caregiver; pediatric surgery; mobile health intervention; positive psychology intervention

Outcome Measures

Primary Outcomes (3)

• Recruitment Potential (Feasibility)

  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.

  Up to 74 days (60 days post-surgery)

• Module Engagement (Feasibility)

  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.

  Up to 74 days (60 days post-surgery)

• Module Engagement (Feasibility)

  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.

  Up to 74 days (60 days post-surgery)

Secondary Outcomes (8)

• Adolescent Global Health

  Up to 74 days (60 days post-surgery)

• Caregiver Global Health

  Up to 74 days (60 days post-surgery)

• Adolescent pain intensity

  Up to 74 days (60 days post-surgery)

• Adolescent Pain Interference

  Up to 74 days (60 days post-surgery)

• Adolescent Mood

  Up to 74 days (60 days post-surgery)

Study Arms (2)

Positive Activity Interventions + Surveys

ACTIVE COMPARATOR

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.

Behavioral: Behavioral Treatment

Surveys Only

NO INTERVENTION

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.

Interventions

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.

Also known as: Positive Activity Exercises

Positive Activity Interventions + Surveys

Eligibility Criteria

• Age: 12 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (3)

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

Ann Arbor, Michigan, 48109, United States

Location

University of Michigan affiliated hospitals

Ann Arbor, Michigan, 48109, United States

Location

Michigan Medicine- Brighton Center for Specialty Care

Brighton, Michigan, 48116, United States

Location

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• Rabbitts JA, Groenewald CB. Epidemiology of Pediatric Surgery in the United States. Paediatr Anaesth. 2020 Oct;30(10):1083-1090. doi: 10.1111/pan.13993. Epub 2020 Aug 29.

  PMID: 32777147 BACKGROUND

MeSH Terms

Interventions

Behavior Therapy

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sydney Brown, MD PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sydney Brown, MD PhD

CONTACT

734-803-3152; sydbro@umich.edu

Emma Wymer, BA

CONTACT

734-998-4551; wymere@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The statistician will be masked. The research assistant performing the chart review of the electronic health record will be masked. The PI will be masked, except during the qualitative interviews in which masking would be impossible. Care provider will be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 28, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After the primary results have been published in a peer-reviewed journal. Study data that is stored at the University of Michigan will be available to the research community in perpetuity.
• Access Criteria: All deidentified study data that are not designated as restricted use will be made available on request by contacting the PI or The University of Michigan Department of Anesthesiology. Users must complete a mutually agreed upon data sharing plan, be qualified and approved by the University of Michigan, and agree to the Terms of Use. These processes are designed to protect study participants by limiting data use to scientific research and aggregate statistical reporting, prohibiting attempts to identify study participants, and requiring immediate reporting of any disclosure of study participant identity. Data users also agree not to share or redistribute any data downloads.

Locations

US (3)