Recruiting

Observational Study

Sponsor:

Medical University of South Carolina

Code:

NCT06035939

Conditions

Sickle Cell Disease

Eligibility Criteria

Sex: All

Age: 14 - 21

Healthy Volunteers: Accepted

Interventions

Voice Crisis Alert V2

Electronic educational materials

Study Details

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.

Conditions

Sickle Cell Disease

Study ID

NCT06035939

Start date

Apr 4, 2024

Status verified date

Dec, 2025

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 21

Healthy Volunteers: Accepted

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

Study Design

Enrollment

272 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention

Study participants randomized to receive the intervention.

active comparator: Control

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

Interventions

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.

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 measure

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

Central Contacts and Locations

Central contacts

Shannon Phillips, PhD, RN

843-792-9379phillipss@musc.edu

Margie Prentice, MBA

843-792-4771prenticm@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Shannon Phillips, PhD, RN

843-792-9379phillipss@musc.edu

Mohan Madisetti

843-792-2059madisett@musc.edu

More Information

Sponsor

Medical University of South Carolina

Last update posted

Dec 8, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2025-12-08.