Examining the Knowledge, Attitudes, and Beliefs of Sickle Cell Disease Patients, Parents of Patients With Sickle Cell Disease, and Providers Towards the Integration of CRISPR in Clinical Care
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|ClinicalTrials.gov Identifier: NCT03167450|
Recruitment Status : Completed
First Posted : May 30, 2017
Last Update Posted : February 9, 2021
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Sickle cell disease (SCD) is caused by a genetic defect that affects how hemoglobin is made. Due to this, people with SCD have abnormally-shaped red blood cells, which can result in poor oxygen transport in the body and increase risk of blood clots. CRISPR Cas9 is a new tool which allows scientists to snip and edit genes in a way that is faster, cheaper, and more precise than other gene-editing tools. Recently, research has been done using CRISPR Cas9 to correct the sickle cell gene in animal models and human cells. Researchers want to understand the views of those with SCD, parents of people with SCD, and the providers of these patients regarding use of CRISPR Cas9 in clinical trials and treatment.
To study the attitudes, beliefs, and opinions of those with SCD, parents of those with SCD, and providers on the use of CRISPR Cas9 gene-editing. An additional purpose of this study is to assess the utility of an educational tool for improving understanding of CRISPR Cas9.
People ages 18 and older who speak English and either have SCD, are a parent of someone with SCD, or are a physician for people with SCD.
Participants will be screened via phone. Those with SCD will be screened with data from their SCD genotype.
Participation lasts about 2 hours.
Participants will fill out three surveys.
Participants will watch a video about CRISPR Cas9.
Participants will engage in a focus group session. This will be audiotaped and analyzed.
The data from the survey questions and focus groups may be used for future research. However, all personally identifiable information will be removed before data is shared.
Participants data will be identified with a code number instead of their name.
Participants may be invited to join future studies of SCD.
|Condition or disease|
|Sickle Cell Disease|
|Study Type :||Observational|
|Actual Enrollment :||109 participants|
|Official Title:||Examining the Knowledge, Attitudes, and Beliefs of Sickle Cell Disease Patients, Parents of Patients With Sickle Cell Disease, and Providers Towards the Integration of CRISPR in Clinical Care|
|Actual Study Start Date :||April 28, 2017|
|Actual Primary Completion Date :||December 31, 2017|
|Actual Study Completion Date :||February 5, 2021|
Adults have sickle cell disease
Parents with children/adults who have sickle cell disease
Physicians who have delivered healthcare to individuals living with sickle cell disease for at least a year
- Focus group interviews related to attitudes, beliefs, and opinions of those with SCD, parents of those with SCD, and providers on the use of CRISPR Cas9 gene-editing. [ Time Frame: At the day of inclusion ]
- To assess the utility of an educational tool for improving understanding of CRISPR Cas9. [ Time Frame: At the day of inclusion ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- INCLUSION CRITERIA:
The inclusion criteria for patients:
- must have a diagnosis of sickle cell disease
- must be 18 years or older
- must be English-speaking
The inclusion criteria for parents of patients with SCD:
- must have a child with sickle cell disease
- must be 18 years or older
- must be English speaking
Lastly, the inclusion criteria for physicians:
- must care for sickle cell patients
- must have cared for sickle cell patients for a minimum of 12 months
- must have been the caregiver for at least five adult patients and/or five pediatric patients
- must be 18 years or older
- must be English-speaking.
The participants need to be 18 years or older in order to provide informed consent. It is necessary that participants speak English due to the nature of the study. Because a moderated conversation will take place, it is essential that all participants and researchers speak the same language to allow for interactive discourse and comprehension.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03167450
|United States, Maryland|
|National Human Genome Research Institute (NHGRI)|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Vence L Bonham, J.D.||National Human Genome Research Institute (NHGRI)|
|Responsible Party:||National Human Genome Research Institute (NHGRI)|
|Other Study ID Numbers:||
|First Posted:||May 30, 2017 Key Record Dates|
|Last Update Posted:||February 9, 2021|
|Last Verified:||February 2021|
Participation Clinical Trials
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn