Multicomponent Intervention Study- Blood Donors With High Cholesterol

Lipid Metabolism Disorder Clinical Trial

— DONATE-FH  

Official title:

Implementing a Multicomponent Intervention to Treat Blood Donors With Familial Hypercholesterolemia

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
• 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
• 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)

Related Conditions & MeSH terms

• Lipid Metabolism Disorder
• Lipid Metabolism Disorders
• Metabolic Diseases

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