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Implementation Strategy Bundle for Lipid Disorders (DONATE-FH Trial)

N/A
Recruiting
Led By Amit Khera, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to improve cholesterol treatment for those with a genetic condition called FH.

Who is the study for?
This trial is for blood donors aged 18 to 75 who have high cholesterol that fits the MEDPED criteria for Familial Hypercholesterolemia. It's not suitable for pregnant individuals, those with a secondary cause of high lipids, liver disease, or anyone already on cholesterol-lowering meds or drugs interacting with statins.
What is being tested?
The study aims to see if an 'Implementation Strategy Bundle' can better manage cholesterol in participants compared to just notifying them about their condition ('Usual care notification').
What are the potential side effects?
Since this trial focuses on strategies rather than medications, direct side effects are not specified. However, any intervention could potentially lead to stress or anxiety related to health awareness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in change in LDL cholesterol levels from baseline to 6 months
Secondary study objectives
Difference in 6 month LDL-C values between the two treatment arms
Difference in participants' knowledge regarding FH at the end of study
Proportion of participants prescribed any statin therapy
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Intervention Group (Implementation strategy bundle)Experimental Treatment2 Interventions
Along with standard high cholesterol notification from Carter BloodCare, this arm will receive Implementation strategy bundle (educational material regarding high cholesterol levels)
Group II: Control group (Usual care)Experimental Treatment1 Intervention
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

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,083 Previous Clinical Trials
1,058,089 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,935 Previous Clinical Trials
47,792,231 Total Patients Enrolled
Amit Khera, MDPrincipal InvestigatorUT Southwestern Medical Center

Media Library

Implementation Strategy Bundle Clinical Trial Eligibility Overview. Trial Name: NCT05693701 — N/A
Lipid Disorder Research Study Groups: Control group (Usual care), Intervention Group (Implementation strategy bundle)
Lipid Disorder Clinical Trial 2023: Implementation Strategy Bundle Highlights & Side Effects. Trial Name: NCT05693701 — N/A
Implementation Strategy Bundle 2023 Treatment Timeline for Medical Study. Trial Name: NCT05693701 — N/A
~56 spots leftby Feb 2027
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