SCThrive for Sickle Cell Anemia

(SC-Thrive Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Lori E. Crosby, PsyD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Chronic disease, Non-English, Cognitive disorder

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the impact of SCThrive (a behavioral self-management intervention) on patient activation, self-management behaviors, daily functioning, and emergency room visits in 260 adolescents and young adults with sickle cell disease (SCD) ages 13-21 receiving care at 1 of 4 pediatric SCD clinics. The main question\[s\]it aims to answer are: * Does SCThrive improve patient activation? * Does SCThrive improve self-management behaviors, daily functioning, and decrease emergency room visits? * Are any improvements maintained 3 months after treatment? Participants will complete self-management related surveys before, after, and 3 months following their participation in an 8- week, virtual group intervention with an accompanying mobile app (SCThrive). Researchers will compare outcomes for participants who receive SCThrive and participants who receive uniform standard care (SCHealthED which = standard of care plus SCD educational text messages) to see if there are differences in patient activation, self-management behaviors, daily functioning, and emergency room visits.

Do I need to stop my current medications for the SCThrive trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on a behavioral intervention, so it's likely you can continue your usual medications, but please confirm with the study team.

How is the drug SCThrive different from other sickle cell anemia treatments?

SCThrive may be unique in its approach by potentially inducing fetal hemoglobin (HbF), which is a strategy used to treat sickle cell anemia by reducing the sickling of red blood cells. This mechanism is different from other treatments like hydroxyurea, L-Glutamine, crizanlizumab, and voxelotor, which focus on reducing pain crises, improving anemia, and enhancing quality of life.

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Eligibility Criteria

This trial is for adolescents and young adults aged 13-21 with a confirmed diagnosis of sickle cell disease (SCD), who are patients at one of the participating SCD clinics. It's not specified what conditions exclude someone from participation.

Inclusion Criteria

I am a patient at a participating SCD Clinic.

I have been diagnosed with sickle cell disease.

I am between 13 and 21 years old.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in an 8-week virtual group intervention with the SCThrive app

8 weeks

Virtual sessions

Follow-up

Participants are monitored for maintenance of improvements in self-management behaviors and patient activation

3-4 months

Participant Groups

The study tests SCThrive, an 8-week virtual group intervention with a mobile app, against standard care plus educational texts (SCHealthED). The goal is to see if SCThrive improves patient activation, self-management behaviors, daily functioning, and reduces emergency room visits.

Group I: Active Treatment Active Control 1 Intervention

SCThrive is a virtual, 8-week, virtual group-based, behavioral self-management intervention that includes daily use of a companion mobile app.

Group II: Control Condition Placebo Group 1 Intervention

Participants randomized to SCHealthED will receive usual care plus 7 text messages consisting of SCD educational facts to ensure the care is uniform across sites.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Nemours Children's Health Wilmington, DE

Children's Healthcare of Atlanta Atlanta, GA

Cincinnati Children's Hospital Medical Center Cincinnati, OH

Children's Hospital of Philadelphia Philadelphia, PA

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati Lead Sponsor

Children's Hospital of Philadelphia Collaborator

Nemours Children's Health System Collaborator

Emory University Collaborator

References

1. England pubmed.ncbi.nlm.nih.gov

The state of the art of fetal hemoglobin-inducing agents. [2023] Sickle cell anemia (SCA) is a hematological genetic disorder caused by a mutation in the gene of the β-globin. Pharmacological treatments will continue to be an important approach, including the strategy to induce fetal hemoglobin (HbF).

2. England pubmed.ncbi.nlm.nih.gov

Pregnancy in patients with sickle cell disease: maternal and perinatal outcomes. [2022] To compare obstetrical, hematological and neonatal outcomes of pregnant women with or without sickle cell disease (SCD).

3. France pubmed.ncbi.nlm.nih.gov

Sickle cell disease from Africa to Belgium, from neonatal screening to clinical management. [2022] To describe the severity of sickle cell disease (SCD) in newborns in Belgium and evaluate the impact of neonatal screening (NS) on clinical outcome.

4. United States pubmed.ncbi.nlm.nih.gov

Advancements in Sickle Cell Disease (SCD) Treatment: A Review of Novel Pharmacotherapies and Their Impact on Patient Outcomes. [2023] Sickle cell disease (SCD) is a genetic hereditary blood disease that disrupts normal beta-globin production. Patients with SCD experience a broad range of symptoms ranging from anemia, pain crises, and jaundice to acute coronary syndrome and stroke. SCD has been treated with hydroxyurea since 1998. Three important pharmacotherapies have been approved by the Food and Drug Administration (FDA) in the past few years. L-Glutamine has shown efficacy in reducing vaso-occlusive pain crises and hospitalization. Crizanlizumab has also shown positive outcomes in patients with SCD. Voxelotor has been studied to be effective in improving hemolytic anemia and the quality of life in SCD patients. These drugs can be used alone or in conjunction with hydroxyurea. Trials have shown that these therapies have significant efficacy. The events of pain, hemolytic anemia, vaso-occlusive crises, and hospitalizations have been reduced by using these agents. In this editorial, we will discuss these advanced treatment options for patients with SCD.

5. India pubmed.ncbi.nlm.nih.gov

Musculoskeletal complications among children with sickle cell admitted in university of Nigeria teaching hospital ituku - ozalla enugu: a 58 month review. [2021] Sickle cell anemia (SCA) is a genetic hematological disorder characterized by red blood cells that assume abnormal, rigid, and sickle shape. The musculoskeletal complications of SCA result from vessel occlusion, leading to tissue ischemia and infarction and progressive end organ damage.