Multicomponent Intervention Study- Blood Donors With High Cholesterol

Conditions

• Lipid Metabolism Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Implementation Strategy Bundle — BEHAVIORAL
  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.
• Usual care notification — OTHER
  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.

Study Details

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

Key Dates

Start date

Feb 27, 2023

Status verified

Mar 2026

Primary completion

Apr 30, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• 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
• 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)

Primary Outcome Measure

Difference in change in LDL cholesterol levels from baseline to 6 months [ Time Frame: Baseline, 6 months ]

Central Contacts

• Amit Khera, MD
  214.645.7500
  [email protected]
• Lakeisha Cade
  214.648.2878
  [email protected]

Locations (1)

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