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Intervention Group (Implementation strategy bundle) for Lipid Metabolism Disorder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UT Southwestern Medical Center, Dallas, TXLipid Metabolism DisorderImplementation Strategy Bundle - Behavioral
Eligibility
18 - 75
All Sexes
What conditions do you have?
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Study Summary

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

Eligible Conditions
  • Lipid Metabolism Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 6 months

6 months
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
Proportion of participants prescribed high-intensity statin therapy
Baseline, 6 months
Difference in change in LDL cholesterol levels from baseline to 6 months

Trial Safety

Safety Progress

1 of 3

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1
Melatonin 3 mg
2
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3
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Trial Design

1 Treatment Group

Intervention Group (Implementation strategy bundle)
1 of 1

Experimental Treatment

100 Total Participants · 1 Treatment Group

Primary Treatment: Intervention Group (Implementation strategy bundle) · No Placebo Group · N/A

Intervention Group (Implementation strategy bundle)Experimental Group · 2 Interventions: Implementation Strategy Bundle, Usual care notification · Intervention Types: Behavioral, Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
962 Previous Clinical Trials
1,108,287 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,616 Previous Clinical Trials
47,118,096 Total Patients Enrolled
Amit Khera, MDPrincipal InvestigatorUT Southwestern Medical Center

Eligibility Criteria

Age 18 - 75 · All Participants · 2 Total Inclusion Criteria

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References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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