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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05693701
Other study ID # STU-2020-1366
Secondary ID 1R61HL161753-01
Status Recruiting
Phase N/A
First received
Last updated
Start date February 27, 2023
Est. completion date February 28, 2027

Study information

Verified date February 2024
Source University of Texas Southwestern Medical Center
Contact Amit Khera, MD
Phone 214.645.7500
Email Amit.Khera@UTSouthwestern.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose and objective of this study is to improve cholesterol treatment among blood donors with FH (Familial Hypercholesterolemia).


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date February 28, 2027
Est. primary completion date February 28, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Blood donors from Carter BloodCare with high cholesterol meeting MEDPED FH criteria - Age 18 to 75 years Exclusion Criteria: - Currently taking medication to lower cholesterol - Taking any medication that can interact with statins - Pregnancy - Identified secondary cause of elevated lipids - Chronic liver disease or significantly elevated liver function tests (> 3 times upper limit)

Study Design


Intervention

Behavioral:
Implementation Strategy Bundle
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.
Other:
Usual care notification
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.

Locations

Country Name City State
United States UT Southwestern Medical Center Dallas Texas

Sponsors (2)

Lead Sponsor Collaborator
University of Texas Southwestern Medical Center National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in change in LDL cholesterol levels from baseline to 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 Baseline, 6 months
Secondary Difference in 6 month LDL-C values between the two treatment arms This is the difference between the two study arms in the 6 month LDL cholesterol levels obtained from lab work of blood samples. 6 months
Secondary Proportion of participants prescribed high-intensity statin therapy 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 6 months
Secondary Proportion of participants prescribed any statin therapy 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 6 months
Secondary Difference in participants' knowledge regarding FH at the end of study 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. 6 months
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