UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Location status: Recruiting
Location contact
Amit Khera, MD
CONTACT
Amit Khera, MD
PRINCIPAL_INVESTIGATOR
Lakeisha Cade
CONTACT
NCT Number: NCT05693701
The purpose and objective of this study is to improve cholesterol treatment among blood donors with FH (Familial Hypercholesterolemia).
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Dallas, Texas, 75390, United States
Location status: Recruiting
Amit Khera, MD
CONTACT
Amit Khera, MD
PRINCIPAL_INVESTIGATOR
Lakeisha Cade
CONTACT
This is a single center randomized, two arm trial. The two study arms include usual care (standard notification) and implementation bundle intervention. UT Southwestern Medical Center will be the main study site and Carter Blood Care will serve as the recruitment site.
Screening/Baseline visit: Donors agreeing to participate in the study will be informed of study procedures and will provide informed consent. A 20 mL blood sample as well as a urine sample will be obtained for eligibility screening laboratories and baseline LDL-C.
Follow-up phone call: At 3 months post-randomization, participants in both arms will be briefly contacted by phone by the Research Assistant to thank them for their participation and to answer any study related questions.
End of study 6 month visit. Participants will engage in a virtual visit for end of study procedures. At this follow-up visit, the Research Assistant will assess for any adverse events and direct the participant to collect a fasting blood sample for repeat LDL-C measurement. The Research Assistant will administer an electronic survey and knowledge questionnaires. Additional clinical visits as desired by the participants' physicians will be allowed at their discretion.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Bundle includes multimodal communications to notify donors about high cholesterol and its treatment, website with resources, and an optional care navigator. Resources for their primary care provider will also be disseminated.
Carter BloodCare will notify participants of their high cholesterol, potential for genetic causes, and recommendation to see their care provider by sending its routine, standard notification letter. These participants will also be eligible to receive the intervention bundle at the end of the study.
Time frame: Baseline, 6 months
This is the difference between the two study arms in change in LDL cholesterol level measurements obtained from lab work of blood samples from baseline and at 6 months
Time frame: 6 months
This is the difference between the two study arms in the 6 month LDL cholesterol levels obtained from lab work of blood samples.
Time frame: 6 months
Proportion of participants prescribed high-intensity statin therapy will be calculated as the number of patients who were prescribed high-intensity statin therapy in each arm divided by the total number of participants analyzed in each arm
Time frame: 6 months
Proportion of participants prescribed any statin therapy will be calculated as the number of patients who were prescribed any statin therapy in each arm divided by the total number of participants analyzed in each arm
Time frame: 6 months
Difference in participant's knowledge regarding FH at 6 months is measured using a validated FH knowledge survey where higher scores indicate greater knowledge. Comparisons between the two study arms will be made.
Contact information is provided by the study sponsor or research team.
Amit Khera, MD
CONTACT
Lakeisha Cade
CONTACT
University of Texas Southwestern Medical Center
Other
Implementing a Multicomponent Intervention to Treat Blood Donors With Familial Hypercholesterolemia
Acronym: DONATE-FH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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