SMYLS Multi-site Trial

Study Overview
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Brief Summary
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The purpose of this study is to find out whether a web-based intervention using a mobile app is helpful for teens and young adults with sickle cell disease (SCD) in learning how to care for and manage their symptoms.

Detailed Description
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The purpose of this study is to test the effectiveness of and identify barriers and facilitators to the implementation of SMYLS, an mHealth intervention designed to facilitate self-management behaviors in adolescents and young adults (AYA) with sickle cell disease (SCD). Specifically, the investigators propose to determine the effect of the intervention on the primary outcome of self-management behaviors and the secondary outcomes of quality of life, transition readiness, healthcare utilization, and pain interference. In addition, the investigators will explore how patient activation moderates development of self-management behaviors and systemic, structural, and social variables that moderate relationships between patient activation, the primary outcome, and secondary outcomes.

Official Title
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Self-Management for Youth Living With Sickle Cell Disease: SMYLS Multi-site Trial

Conditions
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Sickle Cell Disease

Intervention / Treatment
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* Behavioral: Voice Crisis Alert V2
* Behavioral: Electronic educational materials


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: documentation in the electronic health record of any type of SCD owns mobile device compatible with the intervention access to the internet Exclusion Criteria: Plans to relocate outside of study site area in the next 12 months Plans to transition to adult care in 12 months or less Parent/caregiver or provider report of neurocognitive impairment that precludes ability to use intervention and participate in study non-English speaking

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Study participants randomized to receive the intervention. | Behavioral: Voice Crisis Alert V2<br>* The mHealth self-management intervention consists of the following components: 1) condition-specific electronic educational materials; 2) pain/symptom monitoring and tracking; 3) health history information documentation; 4) medication tracking; 5) secure messaging with a provider; 6) functioning monitoring and tracking; and 7) transmission of health information (graphs with recorded pain and functioning histories) to a provider.<br>|
| Active Comparator: Control<br>Study participants randomized to receive enhanced usual care (control). | Behavioral: Electronic educational materials<br>* The control arm will receive enhanced usual care, which will consist of usual educational materials distributed at the clinic plus a version of the intervention (Voice Crisis Alert V2) that only includes the electronic educational materials.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-management behaviors | Adolescent and young adult self-report using the Transition Readiness Assessment Questionnaire 5th version (TRAQ-5; 20 items). The instrument consists of 5 scales. Individual item scores range from 1 - 5. Scale scores are determined by calculating the average of the item scores within each scale. Higher scores indicate greater transition readiness and self-management behaviors. | baseline and 1, 3, 6, 9, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engagement in intervention/control (categorical) | Categorized into none, low, moderate and high. For intervention arm, categories are based on scope (number of components), duration (number of weeks), and frequency (number of times per week). For control arm, categories are based on duration and frequency as for intervention group parameters. | baseline and 1, 3, 6, 9, 12 months | 
| Engagement in intervention/control (continuous) | Number of times the application is accessed (intervention = full application; control = educational component only). | Ongoing | 
| Health-related quality of life | Adolescent and young adult self report using the Pediatric Quality of Life Inventory (PedsQL) with Sickle Cell Disease Module (43 items). Items are scaled from 0 (Never) to 4 (Almost always). Scores are reverse scored and linearly transformed to a 0 - 100 scale. Higher scores indicate better health-related quality of life. | baseline and 1, 3, 6, 9, and 12 months | 
| Number of attended SCD clinic visits | Number of attended SCD clinic visits documented in the medical record | baseline and 1, 3, 6, 9, and 12 months | 
| Number of ED visits | Number of ED visits documented in the medical record | baseline and 1, 3, 6, 9, and 12 months | 
| Number of hospitalizations | Number of hospitalizations documented in the medical record | baseline and 1, 3, 6, 9, and 12 months | 
| Pain interference | Adolescent and young adult self report using the Patient Reported Outcomes Measurement Inventory System (PROMIS) Pain Interference v2 Pediatric Short Form (8 items). Raw scores range from 0 - 32 with higher scores indicating greater pain interference. | baseline and 1, 3, 6, 9, and 12, months | 
| Transition readiness | Adolescent and young adult self report using the Transition Intervention Program - Readiness for Transition (TIP-RFT; 22 items). Scores for each item range from 0 - 4, with a total possible summed score ranging from 0 - 88. Lower scores indicate higher transition readiness. | baseline and 1, 3, 6, 9, and 12 months |