SMYLS Multi-site Trial

Medical University of South Carolina (MUSC)

Status: Enrolling

Conditions: Sickle Cell Disease

Treatments: Behavioral: Electronic educational materials; Behavioral: Voice Crisis Alert V2

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06035939

1R01NR020606-01 (U.S. NIH Grant/Contract)

Pro00127137

Details and patient eligibility

About

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.

Full 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.

Enrollment: 272 estimated patients

Sex: All

Ages: 14 to 21 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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272 participants in 2 patient groups

Intervention

Experimental group

Description:

Study participants randomized to receive the intervention.

Treatment:

Behavioral: Voice Crisis Alert V2

Control

Active Comparator group

Description:

Study participants randomized to receive enhanced usual care (control).

Treatment:

Behavioral: Electronic educational materials