eBook + CHOICES Intervention for Sickle Cell Disease

(CHOICES3 Trial)

Overseen By Amelia Greenlee

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Legally blind, Hysterectomy, Vasectomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a web-based program called CHOICES, designed to assist individuals with sickle cell disease (SCD) or sickle cell trait (SCT) in planning for children without SCD. Participants will either use this program or read an eBook about SCD and SCT. The goal is to determine if these tools can aid individuals in making informed reproductive choices. Individuals with SCD or SCT who plan to have a child in the next two years and wish to avoid passing on SCD might be well-suited for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could empower future family planning decisions.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the CHOICES program is safe for individuals with sickle cell disease (SCD) or sickle cell trait (SCT). Past studies have demonstrated that CHOICES helps young adults understand genetic inheritance and plan for healthy pregnancies. No reports of harmful effects have emerged from using this program.

CHOICES serves as an educational tool rather than a typical medical treatment. It provides information to help individuals make informed decisions about their reproductive health. As a web-based program, it does not involve medication or medical procedures, making it generally safe and easy to use.

Prospective participants in a trial with the CHOICES program can feel assured that it is designed to help without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CHOICES intervention for sickle cell disease because it offers a novel approach to reproductive education through a web-based platform specifically designed for individuals with sickle cell disease or trait. Unlike traditional educational methods, which may involve in-person consultations or generalized resources, this digital format provides tailored and easily accessible information that can empower patients in managing their reproductive health. The use of technology to deliver personalized education could potentially increase engagement and understanding, making it a promising tool for improving patient outcomes.

What evidence suggests that this trial's treatments could be effective for sickle cell disease?

Research has shown that the CHOICES program, which participants in this trial may receive, can assist individuals with sickle cell disease (SCD) or sickle cell trait (SCT) who are planning to have children. In earlier studies, participants in the CHOICES group were more likely to create a plan to prevent having a child with SCD or SCT. They were more than twice as likely to take this proactive step compared to those who did not join the program. This suggests that CHOICES helps individuals understand genetic risks and make informed family planning decisions. ^{1 2 5 6 7}

Who Is on the Research Team?

Diana Wilkie, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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.

Speaks and reads English

I plan to try for a baby within the next 2 years.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• CHOICES
• eBook

Trial Overview

The 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.

How Is the Trial Designed?

Group I: CHOICES Experimental Treatment 1 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 Group 1 Intervention

Control arm with eBook education focused on sickle cell disease and sickle cell trait.

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A study of 327 parents/guardians of children with sickle cell disease revealed that while 82% had heard of hematopoietic cell transplantation (HCT), nearly half were unsure if it could cure their child, highlighting a gap in awareness.

Parents who discussed HCT with their child's physician were five times more likely to understand its curative potential, indicating that better communication and education from healthcare providers could improve knowledge about this treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent and Guardian Knowledge of Hematopoietic Cell Transplantation as a Treatment Option for Sickle Cell Disease. Stallings, AM., Majhail, NS., Nowacki, AS., et al.[2019]

A web-based patient decision aid for sickle cell disease was developed with input from 223 stakeholders and showed high usability and acceptability, with 72% of participants rating it as good or excellent.

In a randomized clinical trial with 120 participants, the decision aid improved decisional self-efficacy and reduced decisional conflict at 3 months, but did not significantly enhance patient knowledge or involvement in decision making over 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of a Web-Based Patient Decision Aid for Therapeutic Options for Sickle Cell Disease: Randomized Controlled Trial. Krishnamurti, L., Ross, D., Sinha, C., et al.[2020]

An internet-based intervention was developed to help individuals with sickle cell disease (SCD) or sickle cell trait (SCT) make informed reproductive decisions, involving collaboration from a diverse team of professionals and community members.

The culturally specific intervention aims to educate young adults about the implications of SCD and SCT on offspring, and it suggests that healthcare providers can use these insights to better support patients in understanding their reproductive options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an Online Reproductive Health Intervention for Individuals with Sickle Cell Disease or Trait. Johnson-Mallard, V., Oguntoye, A., Eades, N., et al.[2022]

A survey of 209 sickle cell professionals revealed a significant lack of available and satisfactory educational materials focused on patient behavior and psycho-social issues related to sickle cell disease.

Despite the low to moderate use of existing materials, over 90% of respondents expressed interest in educational resources covering various topics, indicating a strong demand for improved patient and parent education in sickle cell care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient education for sickle cell disease: a national survey of health care professionals. Bird, ST., Earp, JA., Drezner, SM., et al.[2019]

A study involving 174 adults and 109 parents of children with sickle cell disease revealed that while both groups are generally open to gene therapies, adults require a higher expected efficacy to accept treatments with significant mortality risks (≥10%).

The severity of sickle cell disease symptoms greatly influences the acceptability of gene therapies; as symptoms worsen, both adults and parents become more willing to accept higher risks for potential benefits, indicating a shift in the benefit-risk balance when facing deteriorating health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preferences for potential benefits and risks for gene therapy in the treatment of sickle cell disease. Gonzalez Sepulveda, JM., Yang, JC., Reed, SD., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A new composite outcome measure, the Stroke Consequences Risk Score, was developed to assess the risk of neurological complications in sickle cell disease, incorporating both motor and neurocognitive deficits based on investigator preferences.

The study confirmed that a placebo-controlled trial for hydroxyurea therapy is both ethical and acceptable to investigators, supporting the need for a phase III trial to evaluate its effectiveness in preventing neurological complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a risk-based composite neurologic outcome for a trial of hydroxyurea in young children with sickle cell disease. Casella, JF., Adams, RJ., Brambilla, DJ., et al.[2020]

Family members of children with sickle cell disease expressed a strong need for comprehensive health guidance, ranging from basic information about the disease to more complex details about complications and prevention strategies.

The study highlights a significant gap in the current support provided to families, emphasizing the urgent need for improved health education initiatives by multidisciplinary teams to enhance understanding and management of sickle cell disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Importance of health guidance for family members of children with sickle cell disease. Figueiredo, SV., Lima, LA., Silva, DPBE., et al.[2022]

The SCKnowIQ questionnaire and CHOICES educational intervention were well-received by participants with sickle cell disease (SCD) or trait (SCT), indicating that the information provided was understandable and relevant.

The intervention group showed significant improvements in knowledge scores after the CHOICES intervention, suggesting potential efficacy, although further research with a larger randomized study is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the SCKnowIQ tool and reproductive CHOICES intervention among young adults with sickle cell disease or sickle cell trait. Gallo, AM., Wilkie, DJ., Wang, E., et al.[2021]

In a study involving 11 participants from four family units, families of children with sickle cell disease (SCD) experienced significant decisional conflict when considering stem cell transplant, indicating uncertainty and potential delays in decision-making.

The research highlighted the importance of family involvement in discussions about transplant options, suggesting that clinicians should facilitate inclusive conversations to address the varying levels of conflict and uncertainty among family members.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Navigating decisional conflict as a family when facing the decision of stem cell transplant for a child or adolescent with sickle cell disease. Schulz, GL., Kelly, KP., Holtmann, M., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

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pmc.ncbi.nlm.nih.gov

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CHOICES is designed to help young adults with SCD or SCT preconception to gain knowledge of genetic inheritance, specify their reproductive health intentions.

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Subjects in the CHOICES group had significantly higher odds of adopting a more proactive parenting plan to avoid having a child with SCD or SCT (OR = 2.3, p = .

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liebertpub.com/doi/full/10.1089/whr.2020.0098

Development of an Online Reproductive Health ...

Reproductive Health CHOICES for young adults with sickle cell disease or trait: Randomized controlled trial outcomes over two years. J Genet ...

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CHOICES3: Sickle Cell Disease Parenting CHOICES

The study will use web-based data collection (SCKnowIQ) and intervention delivery strategies enhanced by nudges and tailored boosters.

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CHOICES for sickle cell reproductive health: A protocol of a ...

CHOICES is designed to help young adults with SCD or SCT preconception to gain knowledge of genetic inheritance, specify their reproductive ...