Health TrialsbyHealthPanel

Multicomponent Intervention Study- Blood Donors With High Cholesterol

ConditionLipid Metabolism Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Texas Southwestern Medical Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Blood donors from Carter BloodCare with high cholesterol meeting MEDPED FH criteria

Age 18 to 75 years

Disqualifiers

Currently taking medication to lower cholesterol

Taking any medication that can interact with statins

Pregnancy

Identified secondary cause of elevated lipids

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Control group (Usual care)Other 1 intervention
Group B: Intervention Group (Implementation strategy bundle)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline, 6 months

Secondary outcomes

1

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.

Time frame
6 months
2

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

Time frame
6 months
3

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

Time frame
6 months
4

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.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Texas Southwestern Medical Center

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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