Self-Management for Youth Living With Sickle Cell Disease: SMYLS Multi-site Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 272
- Locations
- 2
- Primary Endpoint
- Self-management behaviors
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 14 Years to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Intervention
Study participants randomized to receive the intervention.
Intervention: Voice Crisis Alert V2 (Behavioral)
Control
Study participants randomized to receive enhanced usual care (control).
Intervention: Electronic educational materials (Behavioral)
Outcomes
Primary Outcomes
Self-management behaviors
Time Frame: 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 Outcomes
- Number of hospitalizations(baseline and 1, 3, 6, 9, and 12 months)
- Engagement in intervention/control (categorical)(baseline and 1, 3, 6, 9, 12 months)
- Number of ED visits(baseline and 1, 3, 6, 9, and 12 months)
- Number of attended SCD clinic visits(baseline and 1, 3, 6, 9, and 12 months)
- Pain interference(baseline and 1, 3, 6, 9, and 12, months)
- Engagement in intervention/control (continuous)(Ongoing)
- Transition readiness(baseline and 1, 3, 6, 9, and 12 months)
- Health-related quality of life(baseline and 1, 3, 6, 9, and 12 months)
Investigators
Shannon Phillips
Associate Professor-Faculty
Medical University of South Carolina