Sickle Cell DiseaseNCT06035939
SMYLS Multi-site Trial
A study testing Voice Crisis Alert V2 and Electronic educational materials in people with Sickle Cell Disease, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Voice Crisis Alert V2 and Electronic educational materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2024to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- documentation in the electronic health record of any type of SCD
- owns mobile device compatible with the intervention
- access to the internet
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Shannon Phillips, PhD, RN, 843-792-9379, phillipss@musc.edu
Mohan Madisetti, 843-792-2059, madisett@musc.edu
About this study
Official title: Self-Management for Youth Living With Sickle Cell Disease: SMYLS Multi-site Trial
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.
Read the 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.
- Conditions
- Sickle Cell Disease
- Being tested
- Voice Crisis Alert V2, Electronic educational materials
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice Crisis Alert V2Behavioural
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 materialsBehavioural
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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Study participants randomized to receive the intervention. Receives: Behavioral: Voice Crisis Alert V2 |
| Control | Active comparator | Study participants randomized to receive enhanced usual care (control). Receives: Behavioral: Electronic educational materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 1, 3, 6, 9, 12 months
Secondary outcomes (8)
Engagement in intervention/control (categorical)
Categorized into none, low, moderate and high. For intervention arm, categories are based on scope (number of components), duration (number of weeks), and frequency (number of times per week). For control arm, categories are based on duration and frequency as for intervention group parameters.
Measured: baseline and 1, 3, 6, 9, 12 months
Engagement in intervention/control (continuous)
Number of times the application is accessed (intervention = full application; control = educational component only).
Measured: Ongoing
Health-related quality of life
Adolescent and young adult self report using the Pediatric Quality of Life Inventory (PedsQL) with Sickle Cell Disease Module (43 items). Items are scaled from 0 (Never) to 4 (Almost always). Scores are reverse scored and linearly transformed to a 0 - 100 scale. Higher scores indicate better health-related quality of life.
Measured: baseline and 1, 3, 6, 9, and 12 months
Number of attended SCD clinic visits
Number of attended SCD clinic visits documented in the medical record
Measured: baseline and 1, 3, 6, 9, and 12 months
Number of ED visits
Number of ED visits documented in the medical record
Measured: baseline and 1, 3, 6, 9, and 12 months
Number of hospitalizations
Number of hospitalizations documented in the medical record
Measured: baseline and 1, 3, 6, 9, and 12 months
Pain interference
Adolescent and young adult self report using the Patient Reported Outcomes Measurement Inventory System (PROMIS) Pain Interference v2 Pediatric Short Form (8 items). Raw scores range from 0 - 32 with higher scores indicating greater pain interference.
Measured: baseline and 1, 3, 6, 9, and 12, months
Transition readiness
Adolescent and young adult self report using the Transition Intervention Program - Readiness for Transition (TIP-RFT; 22 items). Scores for each item range from 0 - 4, with a total possible summed score ranging from 0 - 88. Lower scores indicate higher transition readiness.
Measured: baseline and 1, 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start4 Apr 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Shannon Phillips, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035939
- Sponsor's protocol ID
- Pro00127137
- Other IDs
- 1R01NR020606-01
- Status last verified
- Dec 2025
- First submitted
- 29 Aug 2023
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.2025.108103. Epub 2025 Oct 4.
PubMed 41052714
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Management for Youth Living With Sickle Cell Disease: SMYLS Multi-site Trial
- ClinicalTrials.gov ID
- NCT06035939
- Acronym / sponsor ID
- Pro00127137
- Conditions
- Sickle Cell Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Voice Crisis Alert V2Study participants randomized to receive the intervention. |
| Control | Active comparator | Behavioral: Electronic educational materialsStudy participants randomized to receive enhanced usual care (control). |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- documentation in the electronic health record of any type of SCD
- owns mobile device compatible with the intervention
- access to the internet
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voice Crisis Alert V2The 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. | Behavioural | Intervention |
| Electronic educational materialsThe 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. | Behavioural | Control |
Primary outcome
Self-management behaviors
Time frame: baseline and 1, 3, 6, 9, 12 months
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Derived from this study: PubMed 41052714Phillips 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.
- Individual participant dataSharing planned: No
Related trials for Sickle Cell Disease
RecruitingObservational study
Blood Sampling for Research Related to Sickle Cell Disease
Sickle Cell Trait, Sickle Cell Disease
Active, not recruitingPhase 2/3
A Study Evaluating the Efficacy and Safety of Mitapivat (AG-348) in Participants With Sickle Cell Disease (RISE UP)
Sickle Cell Disease
Enrolling by invitationObservational study
Blood Collection for Research Related to Certain Diseases Involving Blood Vessels
Sickle Cell Disease
RecruitingPhase 1/2
Repeat Peripheral Blood Stem Cell Transplantation for Patients With Sickle Cell Disease and Falling Donor Myeloid Chimerism Levels
Myeloid Chimerism
Not yet recruitingObservational study
MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voice Crisis Alert V2 and Electronic educational materials in people with Sickle Cell Disease, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shannon Phillips, PhD, RN (843-792-9379, phillipss@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-management behaviors (time frame: baseline and 1, 3, 6, 9, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06035939, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.