Multicomponent Intervention Study- Blood Donors With High Cholesterol (DONATE-FH)

Implementing a Multicomponent Intervention to Treat Blood Donors With Familial Hypercholesterolemia

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

Study Overview

• Status: Recruiting
• Conditions: Lipid Metabolism Disorder
• Intervention / Treatment: Other: Usual care notification; Behavioral: Implementation Strategy Bundle

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amit Khera, MD; Phone Number: 214.645.7500; Email: Amit.Khera@UTSouthwestern.edu
• Study Contact Backup: Name: Lakeisha Cade; Phone Number: 214.648.2878; Email: Lakeisha.Cade@UTSouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • UT Southwestern Medical Center
      • Contact: Amit Khera, MD; Email: BloodDonorStudy@UTSouthwestern.edu
      • Principal Investigator: Amit Khera, MD
      • Contact: Lakeisha Cade; Phone Number: 214.648.2878; Email: BloodDonorStudy@UTSouthwestern.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group (Usual care); This arm will receive standard notification that is usually provided by Carter describing need to review with donor's primary care physician the presence of high cholesterol	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.
Experimental: Intervention Group (Implementation strategy bundle); Along with standard high cholesterol notification from Carter BloodCare, this arm will receive Implementation strategy bundle (educational material regarding high cholesterol levels)	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Amit Khera, MD, University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2023
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Blood Donors; High Cholesterol; LDL Cholesterol
• Additional Relevant MeSH Terms: Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Nutritional and Metabolic Diseases; Hypercholesterolemia; Lipid Metabolism Disorders
• Other Study ID Numbers: STU-2020-1366; 1R61HL161753-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No