NCT06035939

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
272

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Apr 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Apr 2024Jan 2028

First Submitted

Initial submission to the registry

August 29, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

April 4, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

December 8, 2025

Status Verified

December 1, 2025

Enrollment Period

3.3 years

First QC Date

August 29, 2023

Last Update Submit

December 1, 2025

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

  • Self-management behaviors

    Adolescent and young adult self-report using the Transition Readiness Assessment Questionnaire 5th version (TRAQ-5; 20 items). The instrument consists of 5 scales. Individual item scores range from 1 - 5. Scale scores are determined by calculating the average of the item scores within each scale. Higher scores indicate greater transition readiness and self-management behaviors.

    baseline and 1, 3, 6, 9, 12 months

Secondary Outcomes (8)

  • Engagement in intervention/control (categorical)

    baseline and 1, 3, 6, 9, 12 months

  • Engagement in intervention/control (continuous)

    Ongoing

  • Health-related quality of life

    baseline and 1, 3, 6, 9, and 12 months

  • Number of attended SCD clinic visits

    baseline and 1, 3, 6, 9, and 12 months

  • Number of ED visits

    baseline and 1, 3, 6, 9, and 12 months

  • +3 more secondary outcomes

Other Outcomes (11)

  • Patient activation

    baseline and 1, 3, 6, 9, and 12 months

  • Neurocognitive/executive functioning

    baseline, 9 months

  • Social resources and conditions

    baseline, 9 months

  • +8 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Study participants randomized to receive the intervention.

Behavioral: Voice Crisis Alert V2

Control

ACTIVE COMPARATOR

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

Behavioral: Electronic educational materials

Interventions

Electronic educational materialsBEHAVIORAL

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.

Control
Voice Crisis Alert V2BEHAVIORAL

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.

Intervention

Eligibility Criteria

Age14 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • documentation in the electronic health record of any type of SCD
  • owns mobile device compatible with the intervention
  • access to the internet

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Related Publications (1)

  • 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.2025.108103. Epub 2025 Oct 4.

    PMID: 41052714DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Shannon Phillips, PhD, RN

CONTACT

843-792-9379phillipss@musc.edu

Margie Prentice, MBA

CONTACT

843-792-4771prenticm@musc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor-Faculty

Study Record Dates

First Submitted

August 29, 2023

First Posted

September 13, 2023

Study Start

April 4, 2024

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

January 31, 2028

Last Updated

December 8, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)