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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

DONATE-FH Trial 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.Check my eligibility

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').See study design

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.

DONATE-FH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Difference in change in LDL cholesterol levels from baseline to 6 months

Secondary outcome measures

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

DONATE-FH 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,675 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,838 Previous Clinical Trials

47,851,554 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants of any age eligible for this trial?

"The criteria for this study require participants to be between 18 and 75. Additionally, there are 30 studies specifically targeting patients below the age of consent and 83 aimed at those over 65 years old."

Answered by AI

Am I eligible to be a part of this research project?

"This trial is seeking 100 adults aged 18-75 who have a lipid metabolism disorder and meet the MEDPED FH criteria. Furthermore, they must be blood donors of Carter BloodCare with a record of high cholesterol levels."

Answered by AI

What is the estimated size of this research project?

"Indeed, the digital registry hosted on clinicaltrials.gov attests that this medical trial is presently enrolling patients. This project was initially posted on February 27th 2023 and has since been updated accordingly; with the goal of recruiting one hundred participants from a single site."

Answered by AI

Have any recruitment efforts been launched for this experimentation?

"Correct. Information hosted on clinicaltrials.gov confirms that this medical evaluation, which was first made available on February 27th 2023, is currently recruiting participants. The trial's organisers are looking for a total of 100 individuals to enrol at one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Multicomponent Intervention Study- Blood Donors With High Cholesterol

Amit Khera 2023. "Multicomponent Intervention Study- Blood Donors With High Cholesterol". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05693701.

All > Cholesterol