Clinical trial NCT06035939: SMYLS Multi-site Trial
Official title: Self-Management for Youth Living with Sickle Cell Disease: SMYLS Multi-site Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sickle Cell Disease
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2023-09-13
Enrollment: 272
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Self-management behaviors
timeFrame: baseline and 1, 3, 6, 9, 12 months
Secondary outcomes:
measure: Engagement in intervention/control (categorical)
timeFrame: baseline and 1, 3, 6, 9, 12 months
measure: Engagement in intervention/control (continuous)
timeFrame: Ongoing
measure: Health-related quality of life
timeFrame: baseline and 1, 3, 6, 9, and 12 months
measure: Number of attended SCD clinic visits
timeFrame: baseline and 1, 3, 6, 9, and 12 months
measure: Number of ED visits
timeFrame: baseline and 1, 3, 6, 9, and 12 months
measure: Number of hospitalizations
timeFrame: baseline and 1, 3, 6, 9, and 12 months
measure: Pain interference
timeFrame: baseline and 1, 3, 6, 9, and 12, months
measure: Transition readiness
timeFrame: baseline and 1, 3, 6, 9, and 12 months
Other outcomes:
measure: Patient activation
timeFrame: baseline and 1, 3, 6, 9, and 12 months
measure: Neurocognitive/executive functioning
timeFrame: baseline, 9 months
measure: Social resources and conditions
timeFrame: baseline, 9 months
measure: Depressive symptoms
timeFrame: baseline, 9 months
measure: Anxiety
timeFrame: baseline, 9 months
measure: Fatigue
timeFrame: baseline, 9 months
measure: Family functioning
timeFrame: baseline, 9 months
measure: Health literacy
timeFrame: baseline, 9 months
measure: Perceived stigma
timeFrame: baseline, 9 months
measure: Sleep disturbance
timeFrame: baseline, 9 months
measure: Perceived discrimination
timeFrame: baseline, 9 months
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: