Adolescent Surgery Roadmap Feasibility and Acceptability Study
ConditionPediatric Surgical Procedures
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-99
SponsorUniversity of Michigan
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Behavioral Treatment
BehavioralPositive 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Positive Activity Interventions + SurveysActive comparator 1 intervention
Group B: Surveys OnlyNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 74 days (60 days post-surgery)2
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.
Time frame
Up to 74 days (60 days post-surgery)3
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.
Time frame
Up to 74 days (60 days post-surgery)Secondary outcomes
1
Adolescent Global Health
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.
Time frame
Up to 74 days (60 days post-surgery)2
Caregiver Global Health
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.
Time frame
Up to 74 days (60 days post-surgery)3
Adolescent pain intensity
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.
Time frame
Up to 74 days (60 days post-surgery)4
Adolescent Pain Interference
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.
Time frame
Up to 74 days (60 days post-surgery)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: