SMYLS Multi-site Trial

Conditions

• Sickle Cell Disease

Eligibility Criteria

Sex

ALL

Age

14 Years - 21 Years

Healthy Volunteers

Accepted

Interventions

• Voice Crisis Alert V2 — BEHAVIORAL
  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.
• Electronic educational materials — BEHAVIORAL
  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.

Study Details

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.

Key Dates

Start date

Apr 4, 2024

Status verified

Dec 2025

Primary completion

Jul 31, 2027

Completion

Jan 31, 2028

Study Design

Enrollment

272 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Intervention
  Study participants randomized to receive the intervention.
• Active Comparator: Control
  Study participants randomized to receive enhanced usual care (control).

Primary Outcome Measure

Self-management behaviors [ Time Frame: baseline and 1, 3, 6, 9, 12 months ]

Central Contacts

• Shannon Phillips, PhD, RN
  843-792-9379
  [email protected]
• Margie Prentice, MBA
  843-792-4771
  [email protected]

Locations (1)

Find similar trials in Charleston, SC

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