506 Participants Needed

eBook + CHOICES Intervention for Sickle Cell Disease

(CHOICES3 Trial)

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Overseen ByAmelia Greenlee
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The study will use web-based data collection (SCKnowIQ) and intervention delivery strategies enhanced by nudges and tailored boosters in a sample of 430 adult men and women, aged 18-45 yr with SCD (Sickle Cell Disease) or SCT (Sickle Cell Trait), at-risk, and planning within 2 years to have a child free of SCD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the CHOICES treatment for Sickle Cell Disease?

The CHOICES intervention is a web-based educational tool that helps people with sickle cell disease make informed decisions about reproductive health, which is crucial for planning and managing their condition. While the study focuses on reproductive health, it suggests that providing targeted information can empower patients to make better health decisions, potentially improving overall management of sickle cell disease.12345

Is the CHOICES Intervention safe for people with sickle cell disease?

The available research does not provide specific safety data for the CHOICES Intervention, but it is a web-based educational tool, which generally suggests it is safe for use.16789

How is the CHOICES treatment for sickle cell disease different from other treatments?

The CHOICES treatment is unique because it is an online educational program designed to help individuals with sickle cell disease or trait make informed reproductive decisions, focusing on understanding genetic inheritance and parenting options, rather than directly treating the disease itself.17101112

Research Team

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Diana Wilkie, PhD

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for adults aged 18-45 with Sickle Cell Disease (SCD) or Sickle Cell Trait (SCT), who can read and speak English, want to conceive within the next two years, and aim to have a child free of SCD. It's not open to those who've been in CHOICES studies before, are unable to complete study tasks, or cannot have children due to medical reasons.

Inclusion Criteria

I am at risk of having a child with sickle cell disease.
I am between 18 and 45 years old.
Speaks and reads English
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Exclusion Criteria

I am unable to fill out study forms or participate in the study activities.
Report health history of hysterectomy, tubal ligation, medically or surgically induced menopause, or vasectomy that would prevent ability to bear children
I am legally blind.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive web-based reproductive education and tailored interventions for sickle cell disease or trait

24 months
Monthly virtual interactions

Follow-up

Participants are monitored for knowledge retention and behavior changes after intervention

6 months

Treatment Details

Interventions

  • CHOICES
  • eBook
Trial OverviewThe CHOICES3 trial is testing a web-based program designed to help people with SCD/SCT make informed decisions about having children. Participants will use an online platform offering educational content and personalized support strategies aimed at reducing the risk of conceiving a child with SCD.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CHOICESExperimental Treatment1 Intervention
Experimental arm: receives the web-based reproductive education for individuals with sickle cell disease or sickle cell trait
Group II: eBook (electronic-Book)Placebo Group1 Intervention
Control arm with eBook education focused on sickle cell disease and sickle cell trait.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

National Human Genome Research Institute (NHGRI)

Collaborator

Trials
273
Recruited
299,000+

Findings from Research

The CHOICES educational intervention significantly improved reproductive health knowledge among 234 participants with sickle cell disease (SCD) or sickle cell trait (SCT) compared to a standard e-Book intervention, indicating its effectiveness in enhancing understanding of reproductive options.
While the CHOICES group showed changes in intention and planned behavior regarding parenting plans, the overall impact on actual behavior was not significant, suggesting the need for follow-up sessions to reinforce the knowledge gained.
Reproductive health choices for young adults with sickle cell disease or trait: randomized controlled trial immediate posttest effects.Wilkie, DJ., Gallo, AM., Yao, Y., et al.[2022]
The Hemoglobinopathy Learning Collaborative (HLC) aims to enhance care for individuals with sickle cell disease (SCD) by focusing on five key drivers: strong community networks, knowledgeable stakeholders, reliable follow-up, seamless care coordination, and appropriate acute treatment.
Data collection and improvement measures are implemented through a web-based system, involving collaboration among consumers, community organizations, and healthcare providers, which highlights the initiative's potential to improve health outcomes amidst ongoing health reform challenges.
Hemoglobinopathy Learning Collaborative: using quality improvement (QI) to achieve equity in health care quality, coordination, and outcomes for sickle cell disease.Oyeku, SO., Wang, CJ., Scoville, R., et al.[2012]
In a study involving 83 children with sickle cell disease (SCD), it was found that better family functioning and lower parenting stress can improve self-management of SCD, which in turn enhances the health-related quality of life (HRQOL) for these children.
However, the study did not find a significant link between self-management and reductions in SCD pain episodes or urgent health care utilization, suggesting that while family dynamics are important for quality of life, they may not directly influence all health outcomes related to SCD.
Family Functioning, Medical Self-Management, and Health Outcomes Among School-Aged Children With Sickle Cell Disease: A Mediation Model.Psihogios, AM., Daniel, LC., Tarazi, R., et al.[2019]

References

Reproductive health choices for young adults with sickle cell disease or trait: randomized controlled trial immediate posttest effects. [2022]
Hemoglobinopathy Learning Collaborative: using quality improvement (QI) to achieve equity in health care quality, coordination, and outcomes for sickle cell disease. [2012]
Family Functioning, Medical Self-Management, and Health Outcomes Among School-Aged Children With Sickle Cell Disease: A Mediation Model. [2019]
Developing a risk-based composite neurologic outcome for a trial of hydroxyurea in young children with sickle cell disease. [2020]
Comparative Effectiveness of a Web-Based Patient Decision Aid for Therapeutic Options for Sickle Cell Disease: Randomized Controlled Trial. [2020]
Navigating decisional conflict as a family when facing the decision of stem cell transplant for a child or adolescent with sickle cell disease. [2021]
Importance of health guidance for family members of children with sickle cell disease. [2022]
Preferences for potential benefits and risks for gene therapy in the treatment of sickle cell disease. [2023]
Parent and Guardian Knowledge of Hematopoietic Cell Transplantation as a Treatment Option for Sickle Cell Disease. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Development of an Online Reproductive Health Intervention for Individuals with Sickle Cell Disease or Trait. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Evaluation of the SCKnowIQ tool and reproductive CHOICES intervention among young adults with sickle cell disease or sickle cell trait. [2021]
Patient education for sickle cell disease: a national survey of health care professionals. [2019]