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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria (Adolescent Patient):
Inclusion Criteria (Caregiver):
Exclusion Criteria (Adolescent Patient):
Exclusion Criteria (Caregiver):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sydney Brown, MD PhD | Contact | 734-803-3152 | sydbro@umich.edu | |
| Emma Wymer, BA | Contact | 734-998-4551 | wymere@umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sydney Brown, MD PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan Medicine- East Ann Arbor Ambulatory Surgery and Medical Procedures Center | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27739626 | Background | Whittle R, Mansell G, Jellema P, van der Windt D. Applying causal mediation methods to clinical trial data: What can we learn about why our interventions (don't) work? Eur J Pain. 2017 Apr;21(4):614-622. doi: 10.1002/ejp.964. Epub 2016 Oct 14. | |
| 23379553 | Background | Valeri L, Vanderweele TJ. Mediation analysis allowing for exposure-mediator interactions and causal interpretation: theoretical assumptions and implementation with SAS and SPSS macros. Psychol Methods. 2013 Jun;18(2):137-50. doi: 10.1037/a0031034. Epub 2013 Feb 4. |
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all IPD that underlie results in a publication
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.
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.
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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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.
|
|
| Up to 74 days (60 days post-surgery) |
| 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. | Up to 74 days (60 days post-surgery) |
| 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. | Up to 74 days (60 days post-surgery) |
| 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. | Up to 74 days (60 days post-surgery) |
| Adolescent Mood | 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. | Up to 74 days (60 days post-surgery) |
| Adolescent anxiety | 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. | Up to 74 days (60 days post-surgery) |
| Caregiver anxiety | 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. | Up to 74 days (60 days post-surgery) |
| Caregiver mood | 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. | Up to 74 days (60 days post-surgery) |
| University of Michigan affiliated hospitals | Ann Arbor | Michigan | 48109 | United States |
|
| Michigan Medicine- Brighton Center for Specialty Care | Brighton | Michigan | 48116 | United States |
|
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