eBook + CHOICES Intervention for Sickle Cell Disease
(CHOICES3 Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Florida
Disqualifiers: Legally blind, Hysterectomy, Vasectomy, others
No Placebo Group
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.
12345Is 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.
16789How 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.
17101112Eligibility 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
+3 more
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.
+2 more
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
University of FloridaGainesville, FL
Loading ...
Who Is Running the Clinical Trial?
University of FloridaLead Sponsor
National Human Genome Research Institute (NHGRI)Collaborator
References
Reproductive health choices for young adults with sickle cell disease or trait: randomized controlled trial immediate posttest effects. [2022]People with sickle cell disease (SCD) or sickle cell trait (SCT) may not have information about genetic inheritance needed for making informed reproductive health decisions. CHOICES is a Web-based, multimedia educational intervention that provides information about reproductive options and consequences to help those with SCD or SCT identify and implement an informed parenting plan. Efficacy of CHOICES compared with usual care must be evaluated.
Hemoglobinopathy Learning Collaborative: using quality improvement (QI) to achieve equity in health care quality, coordination, and outcomes for sickle cell disease. [2012]Care and outcomes for individuals living with sickle cell disease (SCD) vary across institutions and communities. The Hemoglobinopathy Learning Collaborative (HLC) seeks to improve outcomes across the life course through improvement science. Faculty identified five key drivers of improved outcomes: a strong community network; knowledgeable, proactive individuals, families and providers; reliable identification and follow-up; seamless co-management between primary and specialty care; and appropriate treatment for acute episodes. Using a modified Delphi process, we selected improvement measures aligned with the drivers. Data are collected via a Web-based system linked to a reporting portal. Participating teams include consumers, community organizations and primary and specialty care providers. This commentary reviews the context of SCD in the U.S.; describes the framework, measures, and technology infrastructure already created for the HLC; reports on the early experience of teams; highlights the initiative's challenges and opportunities; and reflects on its implications in the setting of health reform.
Family Functioning, Medical Self-Management, and Health Outcomes Among School-Aged Children With Sickle Cell Disease: A Mediation Model. [2019]Informed by the Pediatric Self-Management Model, the present study tested relationships between parent and family functioning, sickle cell disease (SCD) self-management, and health outcomes for children with SCD.
Developing a risk-based composite neurologic outcome for a trial of hydroxyurea in young children with sickle cell disease. [2020]Studies of interventions to prevent the many neurological complications of sickle cell disease must take into account multiple outcomes of variable severity, with limited sample size. The goals of the studies presented were to use investigator preferences across outcomes to determine an attitude-based weighting of relevant clinical outcomes and to establish a valid composite outcome for a clinical trial.
Comparative Effectiveness of a Web-Based Patient Decision Aid for Therapeutic Options for Sickle Cell Disease: Randomized Controlled Trial. [2020]Hydroxyurea, chronic blood transfusions, and bone marrow transplantation are efficacious, disease-modifying therapies for sickle cell disease but involve complex risk-benefit trade-offs and decisional dilemma compounded by the lack of comparative studies. A patient decision aid can inform patients about their treatment options, the associated risks and benefits, help them clarify their values, and allow them to participate in medical decision making.
Navigating decisional conflict as a family when facing the decision of stem cell transplant for a child or adolescent with sickle cell disease. [2021]Patients with sickle cell disease (SCD) face unpredictable disease, with stem cell transplant being a curative treatment option with risks. The aim of this study was to describe the level and source of decisional conflict in families of children/adolescents with SCD facing a transplant decision.
Importance of health guidance for family members of children with sickle cell disease. [2022]To know the main health guidance needs of family members of children with sickle cell disease.
Preferences for potential benefits and risks for gene therapy in the treatment of sickle cell disease. [2023]Objective of this study is to quantify benefit-risk tradeoffs pertaining to potential gene therapies among adults and parents/caregivers of children with sickle cell disease (SCD). A discrete-choice experiment survey was developed in which respondents selected their preferred treatment alternatives in a series of experimentally controlled pairs of hypothetical gene therapies and a "no gene therapy" option. Gene therapy alternatives were defined based on the chance of eliminating SCD symptoms, expected increases in life expectancy they could offer, treatment-related risk of death, and potential increases in lifetime cancer risk. Respondents made selections based on their current disease severity and in the context of expectations of worsened disease. Three clinical sites and 1 patient organization recruited 174 adult patients and 109 parents of children with SCD to complete the survey. Adult and parent respondents were generally willing to choose gene therapies, but the adults required higher expected levels of efficacy (ie, higher chance of eliminating symptoms) than parents to choose gene therapies that conferred mortality risks of ≥10%. When adults and parents of children with less severe symptoms were asked to consider scenarios of higher levels of disease severity, the increased risk tolerance, and the lowest acceptable level of efficacy for gene therapies with mortality risks dropped by >50%. Baseline SCD symptoms are a major driver of gene therapy acceptability. Adults and parents of patients with milder symptoms may prefer other treatment options; however, an expectation of symptoms deterioration triggers strong reassessment of the acceptable benefit-risk balance of this novel technology.
Parent and Guardian Knowledge of Hematopoietic Cell Transplantation as a Treatment Option for Sickle Cell Disease. [2019]Beginning early in childhood, patients with sickle cell disease (SCD) are at risk of life-threatening and debilitating health events. Despite the high morbidity and mortality of this disease, hematopoietic cell transplantation (HCT), a curative treatment for SCD, remains underutilized. In the literature there is a paucity of data concerning medical decision maker (MDM) awareness of HCT as a treatment option for SCD. The objective of this study was to estimate the proportion of parents/guardians of children with SCD who are aware of HCT as a treatment option, and to identify the demographic factors associated with knowledge of this therapy's curative potential. Between November 2015 and December 2016, 327 parents/guardians were surveyed across 4 clinical sites in 3 Midwestern US cities. Although 82% of parents/guardians had heard of HCT in the past and 78% were aware of the therapy's curative potential, nearly half indicated that they did not know whether HCT could specifically cure their child of the disease. Respondents who had discussed HCT with their child's physician had 5 times higher odds of being aware of HCT's curative potential than those who had not. These findings suggest that additional efforts to enhance MDM knowledge of HCT as well as shared decision making in the use of this therapy, is warranted.
Development of an Online Reproductive Health Intervention for Individuals with Sickle Cell Disease or Trait. [2022]The purpose of this article is to describe the method of developing an internet-based reproductive options intervention to increase informed reproductive decision-making among individuals with sickle cell disease (SCD) or sickle cell trait (SCT). An interprofessional team of graphics and media specialist, nurses, physicians, and researchers collaborated to develop the intervention. Individuals from the community served as advisory board members who reviewed and advised on webpage design, content, delivery, and media. The intervention was theory based, delivered online, and experientially oriented for young adults of reproductive age with SCD or SCT. The intervention was culturally specific, supporting individuals with SCD or SCT in making informed reproductive decisions about transmission of SCD or SCT to their offspring. The intervention could be strengthened to include content on implementing behaviors concordant with informed reproductive decisions. Health care providers can use the result of this study to enhance their knowledge about the complexity of parenting options.
Evaluation of the SCKnowIQ tool and reproductive CHOICES intervention among young adults with sickle cell disease or sickle cell trait. [2021]The study purpose was to evaluate a computer-based questionnaire (SCKnowIQ) and CHOICES educational intervention using cognitive interviewing with childbearing-aged people with sickle cell disease (SCD) or trait (SCT). Ten control group participants completed the SCKnowIQ twice. Ten intervention group participants completed the SCKnowIQ before and after the CHOICES intervention. Most participants found the questionnaire items appropriate and responded to items as the investigators intended. Participants' responses indicated that the information on SCD and SCT and reproductive options was understandable, balanced, important, and new to some. Internal consistency and test-retest reliability were adequate (.47 to .87) for 4 of the 6 scales, with significant within-group changes in knowledge scores for the intervention group but not for the control group. Findings show evidence for potential efficacy of the intervention, but proof of efficacy requires a larger randomized study.
Patient education for sickle cell disease: a national survey of health care professionals. [2019]Despite emphasis on including patient and parent education in sickle cell comprehensive clinical care, literature on the use of such materials is scarce. To discover the availability of, satisfaction with, use of and interest in patient and parent education materials for sickle cell disease, we surveyed, with a 176-item self-administered questionnaire, 209 sickle cell professionals nationwide. Respondents came from 74 sickle cell programs, were 63.4% female and 37.7% African American, and represented many health professions. We found that materials about patient behavior and psycho-social issues, as opposed to those about the disease and treatment, were more often unavailable and, when available, more often unsatisfactory and less frequently used. When available, use of materials was unrelated to satisfaction and perceptions of patient problems for most topics. For each of 10 topics, over 90% of the respondents were interested in materials covering the topic. Future research should examine the low to moderate use of psycho-social and behavioral materials with sickle cell patients, and should assess the appropriateness and effectiveness of existing and new materials.