SMYLS Multi-site Trial
- Conditions
- Sickle Cell Disease
- Interventions
- Behavioral: Electronic educational materialsBehavioral: Voice Crisis Alert V2
- Registration Number
- NCT06035939
- Lead Sponsor
- Medical University of South Carolina
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 272
- documentation in the electronic health record of any type of SCD
- owns mobile device compatible with the intervention
- access to the internet
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Electronic educational materials Study participants randomized to receive enhanced usual care (control). Intervention Voice Crisis Alert V2 Study participants randomized to receive the intervention.
- Primary Outcome Measures
Name Time Method Self-management behaviors baseline and 1, 3, 6, 9, 12 months 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.
- Secondary Outcome Measures
Name Time Method Number of hospitalizations baseline and 1, 3, 6, 9, and 12 months Number of hospitalizations documented in the medical record
Engagement in intervention/control (categorical) baseline and 1, 3, 6, 9, 12 months 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.
Number of ED visits baseline and 1, 3, 6, 9, and 12 months Number of ED visits documented in the medical record
Number of attended SCD clinic visits baseline and 1, 3, 6, 9, and 12 months Number of attended SCD clinic visits documented in the medical record
Pain interference baseline and 1, 3, 6, 9, and 12, months 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.
Engagement in intervention/control (continuous) Ongoing Number of times the application is accessed (intervention = full application; control = educational component only).
Transition readiness baseline and 1, 3, 6, 9, and 12 months 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.
Health-related quality of life baseline and 1, 3, 6, 9, and 12 months 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.
Trial Locations
- Locations (1)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States