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Recruiting NCT06035939

SMYLS Multi-site Trial

No phase Interventional Sickle Cell Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Voice Crisis Alert V2, Electronic educational materials.
Who it may be relevant to
Registry conditions: Sickle Cell Disease. Basic parameters: 14 years — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Behavioral Voice Crisis Alert V2
    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.
  • Behavioral Electronic educational materials
    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.

Primary outcome measures

  • Self-management behaviors [Time frame: baseline and 1, 3, 6, 9, 12 months]
Secondary outcome measures (8)
  • Engagement in intervention/control (categorical) [Time frame: baseline and 1, 3, 6, 9, 12 months]
  • Engagement in intervention/control (continuous) [Time frame: Ongoing]
  • Health-related quality of life [Time frame: baseline and 1, 3, 6, 9, and 12 months]
  • Number of attended SCD clinic visits [Time frame: baseline and 1, 3, 6, 9, and 12 months]
  • Number of ED visits [Time frame: baseline and 1, 3, 6, 9, and 12 months]
  • Number of hospitalizations [Time frame: baseline and 1, 3, 6, 9, and 12 months]
  • Pain interference [Time frame: baseline and 1, 3, 6, 9, and 12, months]
  • Transition readiness [Time frame: baseline and 1, 3, 6, 9, and 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Medical University of South Carolina — Charleston

Publications

  • Phillips S, Martin K, Schlenz AM, Kanter J, Mueller M, Lebensburger J, Galandanci N, Fuh BR, Rivenbark C, Alvarez OA, Hanson RF, Madisetti M, Prentice M, Kelechi TJ. Self-Management for Youth Living with Sickle Cell Disease (SMYLS): A study protocol for a multisite randomized controlled trial testing a behavioral, mHealth app. Contemp Clin Trials. 2025 Nov;158:108103. doi: 10.1016/j.cct.2025.10810 PMID 41052714

Identifiers

NCT: NCT06035939 · Pro00127137 · 1R01NR020606-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗