SCThrive for Sickle Cell Anemia

(SC-Thrive Trial)

Recruiting at 3 trial locations

Overseen By Taylor Richardson, BA

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Chronic disease, Non-English, Cognitive disorder

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

310 Participants Needed

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. ^{1 2 3 4 5}

Research Team

Lori E. Crosby, PsyD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

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.

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

Treatment Details

Interventions

• SCThrive

Trial Overview 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.

Participant Groups

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.

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Nemours Children's Health System

Collaborator

Trials

11

Recruited

17,400+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Findings from Research

Research into drugs that can induce fetal hemoglobin (HbF) is crucial for treating sickle cell anemia (SCA), with a focus on understanding the mechanisms of β-globin regulation to design effective therapies.

Promising strategies include targeting gamma-globin regulation through epigenetic enzymes and exploring the guanylate cyclase and NO/cGMP signaling pathways, which may not only induce HbF but also provide cardiovascular protection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The state of the art of fetal hemoglobin-inducing agents. Pavan, AR., Lopes, JR., Dos Santos, JL.[2023]

Pregnant women with sickle cell disease (SCD) experienced significantly higher rates of complications such as preterm delivery (5 times more likely) and cesarean sections (5 times more likely) compared to healthy pregnant women, based on a study of 60 pregnancies in SCD patients versus 192 in controls.

The SCD-SS subgroup had the most severe outcomes, including lower birth weights for babies (2080 g compared to 2737 g for SCD-SC and 3035 g for controls) and a higher prevalence of maternal complications, indicating that SCD significantly impacts both maternal and neonatal health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregnancy in patients with sickle cell disease: maternal and perinatal outcomes. Costa, VM., Viana, MB., Aguiar, RA.[2022]

Neonatal screening (NS) for sickle cell disease (SCD) in Belgium has led to early detection and improved management, resulting in no deaths in the last 10 years despite the high morbidity associated with the disease.

Out of 96 children studied, 27% experienced no severe clinical events, while 39.6% had severe anemia, highlighting the need for comprehensive care, including prophylactic measures and treatments like hydroxyurea, to enhance clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sickle cell disease from Africa to Belgium, from neonatal screening to clinical management. Lê, PQ., Ferster, A., Cotton, F., et al.[2022]

Recent FDA-approved treatments for sickle cell disease (SCD), including L-Glutamine, Crizanlizumab, and Voxelotor, have demonstrated significant efficacy in reducing pain crises, hospitalizations, and improving hemolytic anemia.

These new therapies can be used alone or alongside hydroxyurea, providing patients with more options to manage their symptoms and improve their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancements in Sickle Cell Disease (SCD) Treatment: A Review of Novel Pharmacotherapies and Their Impact on Patient Outcomes. Khan, SJ., Zaidi, SAT., Murtaza, SF., et al.[2023]

In a study of 78 children with sickle cell anemia (SCA) admitted over 58 months, 32.1% experienced musculoskeletal complications, highlighting a significant health concern in this population.

Acute osteomyelitis was identified as the most common complication, affecting 12.8% of the patients, indicating the need for careful monitoring and management of bone health in children with SCA.

NCBI (Pubmed)

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. Chinawa, J., Chukwu, B., Ikefuna, A., et al.[2021]

References

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

The state of the art of fetal hemoglobin-inducing agents. [2023]

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

Pregnancy in patients with sickle cell disease: maternal and perinatal outcomes. [2022]

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

Sickle cell disease from Africa to Belgium, from neonatal screening to clinical management. [2022]

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]

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]