Adolescent Surgery Roadmap Feasibility and Acceptability Study

Обзор

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

Вмешательства

• Поведенческое Behavioral Treatment
  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 en

Первичные конечные точки

• Recruitment Potential (Feasibility) [Срок оценки: Up to 74 days (60 days post-surgery)]
• Module Engagement (Feasibility) [Срок оценки: Up to 74 days (60 days post-surgery)]
• Module Engagement (Feasibility) [Срок оценки: Up to 74 days (60 days post-surgery)]

Вторичные конечные точки (8)

• Adolescent Global Health [Срок оценки: Up to 74 days (60 days post-surgery)]
• Caregiver Global Health [Срок оценки: Up to 74 days (60 days post-surgery)]
• Adolescent pain intensity [Срок оценки: Up to 74 days (60 days post-surgery)]
• Adolescent Pain Interference [Срок оценки: Up to 74 days (60 days post-surgery)]
• Adolescent Mood [Срок оценки: Up to 74 days (60 days post-surgery)]
• Adolescent anxiety [Срок оценки: Up to 74 days (60 days post-surgery)]
• Caregiver anxiety [Срок оценки: Up to 74 days (60 days post-surgery)]
• Caregiver mood [Срок оценки: Up to 74 days (60 days post-surgery)]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Michigan Medicine- East Ann Arbor Ambulatory Surgery and Medical Procedures Center — Ann Arbor
• University of Michigan affiliated hospitals — Ann Arbor
• Michigan Medicine- Brighton Center for Specialty Care — Brighton

Публикации

• 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. PMID 27739626
• 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. PMID 23379553
• Baron RM, Kenny DA. The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol. 1986 Dec;51(6):1173-82. doi: 10.1037//0022-3514.51.6.1173. PMID 3806354
• Bryant FB. A four-factor model of perceived control: Avoiding, coping, obtaining, and savoring. J Pers. 1989;57(4):773-797.
• Kashdan TB, Uswatte G, Julian T. Gratitude and hedonic and eudaimonic well-being in Vietnam war veterans. Behav Res Ther. 2006 Feb;44(2):177-99. doi: 10.1016/j.brat.2005.01.005. PMID 16389060
• Emmons RA, McCullough ME. Counting blessings versus burdens: an experimental investigation of gratitude and subjective well-being in daily life. J Pers Soc Psychol. 2003 Feb;84(2):377-89. doi: 10.1037//0022-3514.84.2.377. PMID 12585811
• Seligman ME, Steen TA, Park N, Peterson C. Positive psychology progress: empirical validation of interventions. Am Psychol. 2005 Jul-Aug;60(5):410-21. doi: 10.1037/0003-066X.60.5.410. PMID 16045394
• Pennarola BW, Rodday AM, Mayer DK, Ratichek SJ, Davies SM, Syrjala KL, Patel S, Bingen K, Kupst MJ, Schwartz L, Guinan EC, Hibbard JH, Parsons SK; HSCT-CHESS Study. Factors associated with parental activation in pediatric hematopoietic stem cell transplant. Med Care Res Rev. 2012 Apr;69(2):194-214. doi: 10.1177/1077558711431460. Epub 2011 Dec 26. PMID 22203645

Идентификаторы

NCT: NCT06991673 · HUM00265431

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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